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Trial record 3 of 51 for:    "Hypogonadism" | "Estrogens"

Estrogen Dosing in Turner Syndrome: Pharmacology and Metabolism

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ClinicalTrials.gov Identifier: NCT00837616
Recruitment Status : Completed
First Posted : February 5, 2009
Results First Posted : February 10, 2014
Last Update Posted : March 27, 2014
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Nelly Mauras, Nemours Children's Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Turner Syndrome
Hypogonadism
Premature Ovarian Failure
Interventions Drug: 17 B estradiol orally
Drug: 17 B estradiol
Enrollment 41
Recruitment Details Forty-one girls with Turner Syndrome (45X and related karyotypes), between 13 and 20 years were recruited and followed among the 3 participating centers at the Nemours Children’s Clinic, Jacksonville (coordinating center), Nemours Jefferson, and Clínica las Condes/University of Chile, Santiago, Chile.
Pre-assignment Details Any previous growth hormone (GH) therapy was discontinued at least 6 months prior to study participation. Estrogen replacement therapy was discontinued for at least 6 weeks prior to baseline studies. Subjects with significant obesity (BMI > 36 kg/m2) or history of systemic illness were excluded.
Arm/Group Title Oral Estradiol Transdermal Estradiol
Hide Arm/Group Description Group A received the oral estradiol for 12 months Group B received the transdermal estradiol for 12 months
Period Title: Overall Study
Started 20 21
Completed 20 20
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title Group A Group B Total
Hide Arm/Group Description Group A received the oral estradiol for 12 months Group B received the transdermal estradiol for 12 months Total of all reporting groups
Overall Number of Baseline Participants 20 21 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
<=18 years
16
  80.0%
15
  71.4%
31
  75.6%
Between 18 and 65 years
4
  20.0%
6
  28.6%
10
  24.4%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 21 participants 41 participants
16.7  (1.7) 16.7  (1.8) 16.7  (1.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
Female
20
 100.0%
21
 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
Number Analyzed 20 participants 21 participants 41 participants
United States 11 14 25
Chile 9 7 16
1.Primary Outcome
Title Change in Weight From Baseline at 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Estradiol Transdermal Estradiol
Hide Arm/Group Description:
Group A received the oral estradiol for 12 months
Group B received the transdermal estradiol for 12 months
Overall Number of Participants Analyzed 20 20
Mean (Standard Error)
Unit of Measure: kilograms
1.1  (0.6) 1.9  (0.6)
2.Primary Outcome
Title Change in Body Mass Index From Baseline at 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Estradiol Transdermal Estradiol
Hide Arm/Group Description:
Group A received the oral estradiol for 12 months
Group B received the transdermal estradiol for 12 months
Overall Number of Participants Analyzed 20 20
Mean (Standard Error)
Unit of Measure: kg/m2
0.075  (0.38) 0.65  (0.38)
3.Primary Outcome
Title Change in Percent Fat Mass From Baseline in 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Estradiol Transdermal Estradiol
Hide Arm/Group Description:
Group A received the oral estradiol for 12 months
Group B received the transdermal estradiol for 12 months
Overall Number of Participants Analyzed 20 20
Mean (Standard Error)
Unit of Measure: percent fat mass
-0.14  (0.56) -0.64  (0.56)
4.Primary Outcome
Title Change in Fat Free Mass From Baseline at 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Estradiol Transdermal Estradiol
Hide Arm/Group Description:
Group A received the oral estradiol for 12 months
Group B received the transdermal estradiol for 12 months
Overall Number of Participants Analyzed 20 20
Mean (Standard Error)
Unit of Measure: kg
1.03  (0.37) 1.67  (0.4)
5.Primary Outcome
Title Characterize PK/PD and Relative Biological Potency of Different Oral vs TD Estrogen Preparations
Hide Description [Not Specified]
Time Frame 6 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Changes in Insulin Growth Factor-I From Baseline at 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Estradiol Transdermal Estradiol
Hide Arm/Group Description:
Group A received the oral estradiol for 12 months
Group B received the transdermal estradiol for 12 months
Overall Number of Participants Analyzed 20 20
Mean (Standard Error)
Unit of Measure: ng/ml
-16  (12) 28  (12)
7.Secondary Outcome
Title Lipids Concentrations After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Estradiol Transdermal Estradiol
Hide Arm/Group Description:
Group A received the oral estradiol for 12 months
Group B received the transdermal estradiol for 12 months
Overall Number of Participants Analyzed 20 20
Mean (Standard Error)
Unit of Measure: mg/dl
Total Cholesterol 168  (7) 153  (6)
Low Density Lipoprotein 93  (4) 88  (5)
High Density Lipoprotein 56  (3) 50  (2)
Triglycerides 95  (19) 70  (9)
8.Secondary Outcome
Title Rates of Lipid Oxidation After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Estradiol Transdermal Estradiol
Hide Arm/Group Description:
Group A received the oral estradiol for 12 months
Group B received the transdermal estradiol for 12 months
Overall Number of Participants Analyzed 20 20
Mean (Standard Error)
Unit of Measure: Kcal/Fat Free Mass/day
10  (2.8) 7.3  (1.6)
9.Secondary Outcome
Title Serum 17B Estradiol Concentrations After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Estradiol Transdermal Estradiol
Hide Arm/Group Description:
Group A received the oral estradiol for 12 months
Group B received the transdermal estradiol for 12 months
Overall Number of Participants Analyzed 20 20
Mean (Standard Error)
Unit of Measure: pg/ml
124  (19) 74  (17)
10.Secondary Outcome
Title Serum Estrone Concentrations After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Estradiol Transdermal Estradiol
Hide Arm/Group Description:
Group A received the oral estradiol for 12 months
Group B received the transdermal estradiol for 12 months
Overall Number of Participants Analyzed 20 20
Mean (Standard Error)
Unit of Measure: pg/mL
504  (80) 43  (7)
11.Secondary Outcome
Title Serum Estrone Sulfate Concentrations After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Estradiol Transdermal Estradiol
Hide Arm/Group Description:
Group A received the oral estradiol for 12 months
Group B received the transdermal estradiol for 12 months
Overall Number of Participants Analyzed 20 20
Mean (Standard Error)
Unit of Measure: pg/mL
63638  (21088) 1875  (414)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A Group B
Hide Arm/Group Description Group A received the oral estradiol for 12 months Group B received the transdermal estradiol for 12 months
All-Cause Mortality
Group A Group B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group A Group B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A Group B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/21 (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
Layout table for Results Point of Contact information
Name/Title: Dr. Nelly Mauras
Organization: Nemours Children's Clinic
Phone: (904) 697-3674
EMail: nmauras@nemours.org
Layout table for additonal information
Responsible Party: Nelly Mauras, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT00837616     History of Changes
Other Study ID Numbers: 908-M01
First Submitted: February 3, 2009
First Posted: February 5, 2009
Results First Submitted: May 28, 2013
Results First Posted: February 10, 2014
Last Update Posted: March 27, 2014