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Trial record 5 of 17 for:    "Ovarian Cyst" | "Testosterone"

Sex Steroids, Sleep, and Metabolic Dysfunction in Women (SCOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00805207
Recruitment Status : Completed
First Posted : December 9, 2008
Results First Posted : August 1, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Polycystic Ovary Syndrome (PCOS)
Obstructive Sleep Apnea
Obesity
Interventions Drug: Progesterone
Drug: testosterone
Drug: glucocorticoid
Device: continuous positive airway pressure
Drug: Estrogen
Other: Control
Enrollment 61
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Progesterone - PCOS Progesterone - Postmenopausal Women Testosterone - Premenopausal Women Testosterone - Postmenopausal Women Continuous Positive Airway Pressure Glucocorticoid Estrogen Control Control - Baseline Testing Only
Hide Arm/Group Description

Women with obesity and polycystic ovary syndrome

Progesterone: Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.

Postmenopausal women

Progesterone: Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.

Healthy premenopausal women

Testosterone: Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Postmenopausal women

Testosterone: Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Obese women and men with obstructive sleep apnea

continuous positive airway pressure: Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks

Lean and obese healthy women, and obese men

glucocorticoid: Dexamethasone 0.013 mg/kg fat-free mass daily, 21 days

Postmenopausal women

Estrogens: Estrogen treatment (100 ug Estradiol daily) administered 14 days followed by 14 days without treatment. Repeat this cycle 3 times.

Postmenopausal women - tested before and after no treatment. Duration between before and after testing ranged from 31 to 78 days with an average of 46 days between visits Baseline testing only in pre- and postmenopausal women
Period Title: Overall Study
Started 1 9 12 6 3 12 6 6 6
Completed 1 7 11 6 2 9 6 6 6
Not Completed 0 2 1 0 1 3 0 0 0
Reason Not Completed
Protocol Violation             0             0             1             0             0             0             0             0             0
Physician Decision             0             1             0             0             0             1             0             0             0
Withdrawal by Subject             0             1             0             0             1             2             0             0             0
Arm/Group Title Testosterone - Premenopausal Women Testosterone - Postmenopausal Women Progesterone - PCOS Progesterone - Postmenopausal Women Continuous Positive Airway Pressure Glucocorticoid Estrogen Control Control - Baseline Testing Only Total
Hide Arm/Group Description

Healthy, premenopausal women

Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention

Postmenopausal women

Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Women with obesity and polycystic ovary syndrome

Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.

Postmenopausal women

Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.

Women and men with obesity and obstructive sleep apnea

continuous positive airway pressure: Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks

Lean and obese healthy women, and obese men

Dexamethasone 0.013 mg/kg fat-free mass daily taken orally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Postmenopausal women

Estrogen treatment (100 ug Estradiol daily) administered transdermally by using continuous delivery patches. The intervention lasted 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment.

Postmenopausal women

Tested before and after no treatment. Duration between before and after testing ranged from 31 to 78 days with an average of 46 days between visits

Healthy men and women

Baseline testing only

Total of all reporting groups
Overall Number of Baseline Participants 12 6 1 9 3 12 6 6 6 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 6 participants 1 participants 9 participants 3 participants 12 participants 6 participants 6 participants 6 participants 61 participants
35  (8) 57  (6) 22  (0) 63  (7) 62  (12) 38  (13) 59  (10) 64  (6) 41  (15) 49  (16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 6 participants 1 participants 9 participants 3 participants 12 participants 6 participants 6 participants 6 participants 61 participants
Female
12
 100.0%
6
 100.0%
1
 100.0%
9
 100.0%
2
  66.7%
9
  75.0%
6
 100.0%
6
 100.0%
5
  83.3%
56
  91.8%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
3
  25.0%
0
   0.0%
0
   0.0%
1
  16.7%
5
   8.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 6 participants 1 participants 9 participants 3 participants 12 participants 6 participants 6 participants 6 participants 61 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  58.3%
2
  33.3%
0
   0.0%
2
  22.2%
2
  66.7%
3
  25.0%
0
   0.0%
0
   0.0%
3
  50.0%
19
  31.1%
White
5
  41.7%
4
  66.7%
1
 100.0%
7
  77.8%
1
  33.3%
8
  66.7%
6
 100.0%
6
 100.0%
3
  50.0%
41
  67.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 6 participants 1 participants 9 participants 3 participants 12 participants 6 participants 6 participants 6 participants 61 participants
12 6 1 9 3 12 6 6 6 61
1.Primary Outcome
Title Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Secretion Rate
Hide Description VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The hepatic (liver) secretion rates of VLDL-TG was calculated by multiplying the fractional turnover rates of VLDL-TG by the of VLDL-TG concentration.
Time Frame Before and at the end of interventions
Hide Outcome Measure Data
Hide Analysis Population Description

Not included in final analysis:

Withdrawn/withdrew= Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3.

VLDL-TG fractional turnover rate was 3 Standard Deviations from the mean = Testosterone - premenopausal women x 1.

Undetectable VLDL-TG concentration = Progesterone - Postmenopausal women x 1.

Arm/Group Title Testosterone - Premenopausal Women Testosterone - Postmenopausal Women Progesterone - PCOS Progesterone - Postmenopausal Women Continuous Positive Airway Pressure Glucocorticoid Estrogen Control Control - Baseline Testing Only
Hide Arm/Group Description:

Healthy, premenopausal women.

Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Postmenopausal women

Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Women with obesity and polycystic ovary syndrome

Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.

Postmenopausal women

Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.

Women and men with obesity and obstructive sleep apnea

Continuous positive airway pressure: Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks

Lean and obese healthy women, and obese men

Dexamethasone 0.013 mg/kg fat-free mass daily taken orally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Postmenopausal women

Estrogen treatment (100 ug Estradiol daily) administered transdermally by using continuous delivery patches. The intervention lasted 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment.

Postmenopausal women

Tested before and after no treatment. Duration between before and after testing ranged from 31 to 78 days with an average of 46 days between visits

Healthy men and women

Baseline testing only

Overall Number of Participants Analyzed 10 6 1 6 2 9 6 6 6
Mean (Standard Deviation)
Unit of Measure: umol/min/L plasma
Before Number Analyzed 10 participants 6 participants 1 participants 6 participants 2 participants 9 participants 6 participants 6 participants 6 participants
3.13  (2.11) 2.03  (0.35) 4.66 3.36  (1.65) 2.87  (0.03) 3.80  (1.52) 2.87  (0.86) 2.47  (0.85) 3.53  (2.88)
After Number Analyzed 10 participants 6 participants 1 participants 6 participants 2 participants 9 participants 6 participants 6 participants 0 participants
3.00  (1.58) 2.11  (0.80) 7.77 3.24  (1.55) 3.94  (0.42) 3.42  (2.01) 2.94  (1.40) 2.57  (1.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Testosterone - Premenopausal Women
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Glucocorticoid
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Testosterone - Postmenopausal Women, Progesterone - Postmenopausal Women, Estrogen, Control
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments P-value is the main effect of treatment (i.e., Before vs. After) from ANOVA
Method ANOVA
Comments VLDL-TG secretion rates were skewed and log transformed prior to performing ANOVA
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Testosterone - Postmenopausal Women, Progesterone - Postmenopausal Women, Estrogen, Control
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments P-value is the main effect of group (i.e., Testosterone, Progesterone, Estrogen and Control) from ANOVA
Method ANOVA
Comments VLDL-TG secretion rates were skewed and log transformed prior to performing ANOVA
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Testosterone - Postmenopausal Women, Progesterone - Postmenopausal Women, Estrogen, Control
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments P value is the group by treatment interaction from the ANOVA
Method ANOVA
Comments VLDL-TG secretion rates were skewed and log transformed prior to performing ANOVA
2.Secondary Outcome
Title Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentration
Hide Description VLDL was isolated from plasma by ultracentrifugation with VLDL-TG concentration measured by using a colorimetric enzymatic kit (Sigma-Aldrich, St. Louis, MO).
Time Frame Before and at the end of the interventions
Hide Outcome Measure Data
Hide Analysis Population Description

Not included in final analysis:

Withdrawn/withdrew = Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3.

VLDL-TG fractional turnover rate was 3 Standard Deviations from the mean = Testosterone - premenopausal women x 1.

Undetectable VLDL-TG concentration = Progesterone - Postmenopausal women x 1.

Arm/Group Title Testosterone - Premenopausal Women Testosterone - Postmenopausal Women Progesterone - PCOS Progesterone - Postmenopausal Women Continuous Positive Airway Pressure Glucocorticoid Estrogen Control Control - Baseline Testing Only
Hide Arm/Group Description:

Healthy, premenopausal women.

Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Postmenopausal women

Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Women with obesity and polycystic ovary syndrome

Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.

Postmenopausal women

Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.

Women and men with obesity and obstructive sleep apnea

Continuous positive airway pressure: Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks

Lean and obese healthy women, and obese men

Dexamethasone 0.013 mg/kg fat-free mass daily taken orally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Postmenopausal women

Estrogen treatment (100 ug Estradiol daily) administered transdermally by using continuous delivery patches. The intervention lasted 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment.

Postmenopausal women

Tested before and after no treatment. Duration between before and after testing ranged from 31 to 78 days with an average of 46 days between visits

Healthy men and women

Baseline testing only

Overall Number of Participants Analyzed 10 6 1 6 2 9 6 6 6
Mean (Standard Deviation)
Unit of Measure: mmol/L
Before Number Analyzed 10 participants 6 participants 1 participants 6 participants 2 participants 9 participants 6 participants 6 participants 6 participants
0.31  (0.29) 0.18  (0.09) 0.75 0.42  (0.18) 0.50  (0.06) 0.35  (0.16) 0.50  (0.28) 0.30  (0.15) 0.32  (0.17)
After Number Analyzed 10 participants 6 participants 1 participants 6 participants 2 participants 9 participants 6 participants 6 participants 0 participants
0.40  (0.50) 0.18  (0.10) 1.03 0.44  (0.36) 0.64  (0.18) 0.33  (0.22) 0.35  (0.22) 0.28  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Testosterone - Premenopausal Women
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Glucocorticoid
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Estrogen, Control
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Progesterone - Postmenopausal Women, Control
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Testosterone - Postmenopausal Women, Control
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title VLDL-TG Plasma Clearance Rate (Means)
Hide Description VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The plasma clearance rate of VLDL-TG was calculated by dividing the VLDL-TG secretion rate by the VLDL-TG concentration.
Time Frame Before and at the end of the interventions
Hide Outcome Measure Data
Hide Analysis Population Description

Not included in final analysis:

Withdrawn/withdrew= Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3.

VLDL-TG fractional turnover rate was 3 Standard Deviations from the mean = Testosterone - premenopausal women x 1.

Undetectable VLDL-TG concentration = Progesterone - Postmenopausal women x 1.

Arm/Group Title Testosterone - Premenopausal Women Testosterone - Postmenopausal Women Progesterone - PCOS Progesterone - Postmenopausal Women Continuous Positive Airway Pressure Glucocorticoid Estrogen Control Control - Baseline Testing Only
Hide Arm/Group Description:

Healthy premenopausal women.

Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Postmenopausal women

Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Women with obesity and polycystic ovary syndrome

Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.

Postmenopausal women

Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.

Obese women and men with obstructive sleep apnea

continuous positive airway pressure: Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks

Lean and obese healthy women, and obese men

Dexamethasone 0.013 mg/kg fat-free mass daily taken orally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Postmenopausal women

Estrogen treatment (100 ug Estradiol daily) administered transdermally by using continuous delivery patches. The intervention lasted 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment.

Postmenopausal women

Postmenopausal women - tested before and after no treatment. Duration between before and after testing ranged from 31 to 78 days with an average of 46 days between visits

Healthy men and women

Baseline testing only

Overall Number of Participants Analyzed 10 6 1 6 3 9 6 6 6
Mean (Standard Deviation)
Unit of Measure: mL/min
Before Number Analyzed 10 participants 6 participants 1 participants 6 participants 2 participants 9 participants 6 participants 6 participants 4 participants
42.2  (16.3) 35.1  (16.5) 20.3 21.2  (7.5) 19.1  (2.7) 33.8  (11.3) 17.4  (6.7) 22.6  (9.0) 33.1  (13.1)
After Number Analyzed 10 participants 6 participants 1 participants 6 participants 2 participants 9 participants 6 participants 6 participants 0 participants
58.1  (51.6) 34.5  (15.8) 24.6 24.9  (15.3) 20.8  (2.8) 34.3  (21.9) 25.1  (6.1) 23.3  (5.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glucocorticoid
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.94
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Estrogen, Control
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Progesterone - Postmenopausal Women, Control
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Testosterone - Postmenopausal Women, Control
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title VLDL-TG Plasma Clearance Rate (Medians)
Hide Description VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The plasma clearance rate of VLDL-TG was calculated by dividing the VLDL-TG secretion rate by the VLDL-TG concentration.
Time Frame Before and at the end of the interventions
Hide Outcome Measure Data
Hide Analysis Population Description

Not included in final analysis:

Withdrawn/withdrew= Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3.

VLDL-TG fractional turnover rate was 3 Standard Deviations from the mean = Testosterone - premenopausal women x 1.

Undetectable VLDL-TG concentration = Progesterone - Postmenopausal women x 1.

Arm/Group Title Testosterone - Premenopausal Women Testosterone - Postmenopausal Women Progesterone - PCOS Progesterone - Postmenopausal Women Continuous Positive Airway Pressure Glucocorticoid Estrogen Control Control - Baseline Testing Only
Hide Arm/Group Description:

Healthy premenopausal women.

Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Postmenopausal women

Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Women with obesity and polycystic ovary syndrome

Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.

Postmenopausal women

Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.

Obese women and men with obstructive sleep apnea

continuous positive airway pressure: Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks

Lean and obese healthy women, and obese men

Dexamethasone 0.013 mg/kg fat-free mass daily taken orally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Postmenopausal women

Estrogen treatment (100 ug Estradiol daily) administered transdermally by using continuous delivery patches. The intervention lasted 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment.

Postmenopausal women

Postmenopausal women - tested before and after no treatment. Duration between before and after testing ranged from 31 to 78 days with an average of 46 days between visits

Healthy men and women

Baseline testing only

Overall Number of Participants Analyzed 10 6 1 6 3 9 6 6 6
Median (Inter-Quartile Range)
Unit of Measure: mL/min
Before Number Analyzed 10 participants 6 participants 1 participants 6 participants 3 participants 9 participants 6 participants 6 participants 4 participants
40.6
(33.8 to 52.9)
32.1
(23.1 to 47.8)
20.3
20.8
(15.4 to 25.4)
19.1
(18.1 to 20.1)
35.8
(29.6 to 40.5)
14.4
(12.7 to 20.5)
19.6
(16.6 to 26.8)
33.4
(22.8 to 43.7)
After Number Analyzed 10 participants 6 participants 1 participants 6 participants 3 participants 9 participants 6 participants 6 participants 0 participants
43.6
(19.4 to 63.5)
32.7
(24.4 to 48.1)
20.3
22.8
(15.7 to 34.3)
20.8
(19.9 to 21.8)
27.4
(21.5 to 38.7)
24.2
(22.0 to 29.1)
22.3
(19.0 to 26.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Testosterone - Premenopausal Women
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Basal, Postabsorptive Fractional Synthesis Rates of Muscle Protein Synthesis
Hide Description

The fractional synthesis rate (FSR) of muscle protein synthesis was determined by assessing the incorporation of [5,5,5-2H3]leucine into muscle proteins. [5,5,5-2H3]leucine was infused for 5 hours with muscle biopsies obtained from the vastus lateralis muscle in the thigh 2 and 5 hours. The leucine tracer-to-tracee ratio (TTR) in muscle protein and the muscle free leucine pool was determined by gas chromatography-mass spectrometry (GCMS) and the FSR of muscle proteins calculated using a standard precursor-product model.

The FSR was calculated as %/h, which reflects the percent of all proteins in the muscle that were synthesized (made) per hour.

Time Frame Before and at the end of the intervention
Hide Outcome Measure Data
Hide Analysis Population Description

Not included in final analysis:

Withdrawn/withdrew = Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3.

Muscle not obtained = Testosterone - premenopausal women x 1; Progesterone postmenopausal women x 1; CPAP x 3; Glucocorticoid x 6; Control - baseline testing only x 6.

Arm/Group Title Testosterone - Premenopausal Women Testosterone - Postmenopausal Women Progesterone - PCOS Progesterone - Postmenopausal Women Continuous Positive Airway Pressure Glucocorticoid Estrogen Control Control - Baseline Testing Only
Hide Arm/Group Description:

Healthy premenopausal women.

Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Postmenopausal women

Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Women with obesity and polycystic ovary syndrome

Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.

Postmenopausal women

Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.

Women and men with obesity and obstructive sleep apnea

continuous positive airway pressure: Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks

Lean and obese healthy women, and obese men

Dexamethasone 0.013 mg/kg fat-free mass daily taken orally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Postmenopausal women

Estrogen treatment (100 ug Estradiol daily) administered transdermally by using continuous delivery patches. The intervention lasted 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment.

Postmenopausal women

Tested before and after no treatment. Duration between before and after testing ranged from 31 to 78 days with an average of 46 days between visits

Healthy men and women

Baseline testing only

Overall Number of Participants Analyzed 10 6 1 6 0 3 6 6 0
Mean (Standard Deviation)
Unit of Measure: %/h
Before 0.064  (0.023) 0.056  (0.007) 0.049 0.054  (0.12) 0.059  (0.007) 0.063  (0.016) 0.064  (0.012)
After 0.092  (0.024) 0.079  (0.030) 0.083 0.085  (0.018) 0.061  (0.037) 0.063  (0.026) 0.067  (0.011)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Testosterone - Premenopausal Women
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Testosterone - Postmenopausal Women, Progesterone - Postmenopausal Women, Estrogen, Control
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments P-value is the main effect of treatment (i.e., Before vs. After) from ANOVA
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Testosterone - Postmenopausal Women, Progesterone - Postmenopausal Women, Estrogen, Control
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments P-value is the main effect of group (i.e., Testosterone, Progesterone, Estrogen and Control) from ANOVA
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Testosterone - Postmenopausal Women, Progesterone - Postmenopausal Women, Estrogen, Control
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments P value is the group by treatment interaction from the ANOVA
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Testosterone - Postmenopausal Women
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Tukey test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Progesterone - Postmenopausal Women
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Tukey test
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Estrogen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.10
Comments [Not Specified]
Method Tukey test
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Control
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.10
Comments [Not Specified]
Method Tukey test
Comments [Not Specified]
Time Frame Adverse events were monitored over the following periods; Estrogen = 70 days (consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment.); Testosterone = 21 days; continuous positive airway pressure = 6 weeks; Dexamethasone = 21 days; Progesterone = 70 days (consisted of 14 days on, 14 days off, 14 days on, 14 days off and a final 14 days on treatment); Control (no treatment) = 31 to 72 days between testing visits.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Testosterone - Premenopausal Women Testosterone - Postmenopausal Women Progesterone - PCOS Progesterone - Postmenopausal Women Continuous Positive Airway Pressure Glucocorticoid Estrogen Control Control - Baseline Testing Only
Hide Arm/Group Description

Healthy, premenopausal women.

Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Postmenopausal women

Testosterone gel 1250 ug/d applied transdermally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Women with obesity and polycystic ovary syndrome

Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.

Postmenopausal women

Micronized progesterone, 100 mg/d vaginally. The intervention lasts 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment. Testing is performed before and at the end of the 70 day intervention.

Obese women and men with obstructive sleep apnea

Breathe through the mask of a continuous positive airway pressure device every night when sleep, for 6 weeks. Testing is performed before and at the end of the 6 week intervention.

Lean and obese healthy women, and obese men

Dexamethasone 0.013 mg/kg fat-free mass daily taken orally for a total of 21 days. Testing is performed before and at the end of the 21 day intervention.

Postmenopausal women

Estrogen treatment (100 ug Estradiol daily) administered transdermally by using continuous delivery patches. The intervention lasted 70 days in total and consisted of 14 days on treatment, 14 days off treatment, 14 days on treatment, 14 days off treatment and a final 14 days on treatment.

Postmenopausal women

Tested before and after no treatment. Duration between before and after testing ranged from 31 to 78 days with an average of 46 days between visits

Healthy men and women

Baseline testing only

All-Cause Mortality
Testosterone - Premenopausal Women Testosterone - Postmenopausal Women Progesterone - PCOS Progesterone - Postmenopausal Women Continuous Positive Airway Pressure Glucocorticoid Estrogen Control Control - Baseline Testing Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/6 (0.00%)      0/1 (0.00%)      0/9 (0.00%)      0/3 (0.00%)      0/12 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Testosterone - Premenopausal Women Testosterone - Postmenopausal Women Progesterone - PCOS Progesterone - Postmenopausal Women Continuous Positive Airway Pressure Glucocorticoid Estrogen Control Control - Baseline Testing Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/6 (0.00%)      0/1 (0.00%)      0/9 (0.00%)      0/3 (0.00%)      0/12 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Testosterone - Premenopausal Women Testosterone - Postmenopausal Women Progesterone - PCOS Progesterone - Postmenopausal Women Continuous Positive Airway Pressure Glucocorticoid Estrogen Control Control - Baseline Testing Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/6 (0.00%)      0/3 (0.00%)      3/9 (33.33%)      0/3 (0.00%)      0/12 (0.00%)      1/6 (16.67%)      0/6 (0.00%)      0/6 (0.00%)    
Gastrointestinal disorders                   
Vomiting * [1]  0/12 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/3 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Diarrhea * [2]  0/12 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/3 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders                   
Shaking * [3]  0/12 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/3 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Broken ankle * [4]  0/12 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/3 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Reproductive system and breast disorders                   
Vaginal discharge * [5]  0/12 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/3 (0.00%)  0 0/12 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders                   
Acne * [6]  0/12 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/9 (0.00%)  0 0/3 (0.00%)  0 0/12 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Itchiness * [7]  0/12 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/9 (11.11%)  1 0/3 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
One subject in the progesterone group contacted us saying that she was vomiting while not on treatment. Unrelated to treatment was probably due to a viral infection.
[2]
One subject in the progesterone group contacted us saying that she had diarrhea while not on treatment. Unrelated to treatment was probably due to a viral infection.
[3]
One subject in the progesterone group contacted us saying that she was shaking violently while not on treatment. Unrelated to treatment was probably due to a viral infection.
[4]
Subject in Progesterone group broke her ankle while on treatment but unrelated to treatment
[5]
One subject reported that she had a small amount of vaginal discharge while taking estrogen
[6]
One subject reported that she had more acne that usual while taking estrogen
[7]
On subject reported her ankles were itchy while on progesterone
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gordon Smith, PhD
Organization: Washington University in St Louis
Phone: 314-362-4375
EMail: gsmith@wustl.edu
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00805207     History of Changes
Other Study ID Numbers: 07-0692
NIH P50 HD057796
First Submitted: December 5, 2008
First Posted: December 9, 2008
Results First Submitted: February 5, 2018
Results First Posted: August 1, 2018
Last Update Posted: August 1, 2018