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Trial record 87 of 566 for:    "Polycystic Ovary Syndrome"

Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome

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: NCT00989781
Recruitment Status : Completed
First Posted : October 6, 2009
Results First Posted : October 17, 2017
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Jeffrey Chang, MD, University of California, San Diego

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition Polycystic Ovary Syndrome
Interventions Radiation: 3-D Ultrasound
Drug: recombinant human chorionic gonadotropin
Drug: Recombinant human follicle stimulating hormone
Drug: Adrenocorticotropin
Drug: Dexamethasone
Drug: Glucose
Enrollment 41
Recruitment Details Subjects were recruited from UC San Dego clinics and by advertisement in the community. Recruitment began in the summer of 2011 and was completed in Septemebr 2013. Explanation of the research protocol was done by phone and in person.
Pre-assignment Details 41 subjects recruited. 5 dropped out prior to study. Of 36 eligible for adrenal study, 8 dropped out before study,
Arm/Group Title PCOS Women Normal Women
Hide Arm/Group Description

Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).

After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.

After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.

Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).

After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.

After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.

Period Title: Ovarian Response to hCG
Started 21 20
Completed 18 18
Not Completed 3 2
Reason Not Completed
Lost to Follow-up             3             2
Period Title: Adrenal Response ot ACTH
Started 18 [1] 18 [1]
Completed 13 [2] 15 [3]
Not Completed 5 3
[1]
15 subjects that completed part 1 elected to participate in Part 2
[2]
Of 18 eligible, 15 consented. 2 dropped out and 13 completed study
[3]
Of 18 eligible, 15 consented and completed study
Arm/Group Title PCOS Women Normal Women Total
Hide Arm/Group Description

Each subject will undergo pelvic 3D ultrasound followed by an iv recombinant human chorionic gonadotropin (r-hCG) stimulation test. One month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).

After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.

After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT as described above.

Each subject will undergo pelvic 3D ultrasound followed by an iv recombinant human chorionic gonadotropin (r-hCG) stimulation test. One month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).

After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.

After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT as described above.

Total of all reporting groups
Overall Number of Baseline Participants 21 20 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 41 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
 100.0%
20
 100.0%
41
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 41 participants
Female
21
 100.0%
20
 100.0%
41
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 20 participants 41 participants
21 20 41
1.Primary Outcome
Title 17-hydroxyprogesterone Responses to hCG in PCOS Women and Normal Controls
Hide Description Change from baseline in 17-hydroxyprogesterone at 24 hours after hCG injection
Time Frame Baseline and 24 hours after hCG
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NR-PCOS Women HR-PCOS Women Normal Women
Hide Arm/Group Description:

PCOS women with normal 17-OHP responses to hCG are designated as NR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).

After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.

After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.

PCOS women with exaggerated 17-OHP responses to hCG are designated as HR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).

After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.

After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.

Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).

After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.

After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.

Overall Number of Participants Analyzed 10 8 18
Mean (Standard Error)
Unit of Measure: ng/ml
1.3  (0.2) 3  (1) 1.1  (0.2)
2.Secondary Outcome
Title Adrenal 17-hydroxyprogesterone Response to ACTH in PCOS Women and Normal Controls
Hide Description 17-hydroxyprogesterone response to ACTH infusion in women with PCOS and normal women. Response is reported as a single value generated by summing the data at end time frame.
Time Frame Baseline and 1, 2, 3, 4, 5, and 6 hours after ACTH
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NR-PCOS Women HR-PCOS Women Normal Women
Hide Arm/Group Description:

PCOS women with normal 17-OHP responses to hCG are designated as NR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).

After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.

After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.

PCOS women with exaggerated 17-OHP responses to hCG are designated as HR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).

After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.

After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.

Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).

After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.

After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.

Overall Number of Participants Analyzed 6 7 15
Mean (Standard Error)
Unit of Measure: ng/ml
6.0  (0.8) 8.1  (0.4) 6.2  (0.4)
3.Secondary Outcome
Title 17 Hydroxyprogesterone Response to hCG Injection After Lowered Insulin Levels.
Hide Description 17 hydroxyprogesterone levels
Time Frame Baseline and 24 after hCG
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NR-PCOS Women HR-PCOS Women Normal Women
Hide Arm/Group Description:

PCOS women with normal 17-OHP responses to hCG are designated as NR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).

After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.

After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.

PCOS women with exaggerated 17-OHP responses to hCG are designated as HR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).

After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.

After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.

Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).

After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.

After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.

Overall Number of Participants Analyzed 0 2 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Anti-Mullerian Hormone (AMH)
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NR-PCOS Women HR-PCOS Women Normal Women
Hide Arm/Group Description:

PCOS women with normal 17-OHP responses to hCG are designated as NR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).

After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.

After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.

PCOS women with exaggerated 17-OHP responses to hCG are designated as HR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).

After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.

After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.

Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).

After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.

After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.

Overall Number of Participants Analyzed 10 8 18
Mean (Standard Error)
Unit of Measure: ng/ml
16.0  (1.5) 6.7  (1.5) 5.3  (1.0)
5.Other Pre-specified Outcome
Title Follicle Count on 3-D Ultrasound in PCOS Women and Normal Controls
Hide Description 3-D ultrasound was not assessed; instead 2-D ultrasound was performed
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NR-PCOS Women HR-PCOS Women Normal Women
Hide Arm/Group Description:

PCOS women with normal 17-OHP responses to hCG are designated as NR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).

After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.

After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.

PCOS women with exaggerated 17-OHP responses to hCG are designated as HR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).

After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.

After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.

Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).

After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.

After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.

Overall Number of Participants Analyzed 10 8 18
Mean (Standard Error)
Unit of Measure: Antral Follicle Count
64.4  (9.5) 49.3  (5.6) 31.8  (3.4)
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PCOS Women Normal Women
Hide Arm/Group Description

Each subject will undergo pelvic 3D ultrasound and an iv recombinant human chorionic gonadotropin (r-hCG) stimulation test. One month later r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).

After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given before ACTH.

After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals, the r-hCG stimulation test and OGTT will be repeated as described above.

3-D Ultrasound: One time pelvic ultrasound

recombinant human chorionic gonadotropin: Recombinant human chorionic gonadotropin will be given iv and blood samples obtained before and 24 hr afterwards

Recombinant human follicle stimulating

Each subject will undergo pelvic 3D ultrasound and an iv recombinant human chorionic gonadotropin (r-hCG) stimulation test. One month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).

After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.

After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals, the r-hCG stimulation test and OGTT will be repeated as described above.

3-D Ultrasound: One time pelvic ultrasound

recombinant human chorionic gonadotropin: Recombinant human chorionic gonadotropin will be given iv and blood samples obtained before and 24 hr afterwards

Recombinant human follicle stimulati

All-Cause Mortality
PCOS Women Normal Women
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PCOS Women Normal Women
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PCOS Women Normal Women
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%) 
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
Name/Title: R. Jeffrey Chang, M.D.
Organization: UCSD
Phone: 858-534-8930
Responsible Party: Jeffrey Chang, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00989781     History of Changes
Other Study ID Numbers: 090560
First Submitted: October 5, 2009
First Posted: October 6, 2009
Results First Submitted: June 18, 2015
Results First Posted: October 17, 2017
Last Update Posted: June 4, 2018