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Effects of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone

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ClinicalTrials.gov Identifier: NCT01428193
Recruitment Status : Terminated (Haven't enrolled participants since 2010)
First Posted : September 2, 2011
Results First Posted : June 4, 2018
Last Update Posted : June 4, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
John Marshall, University of Virginia

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Polycystic Ovary Syndrome
Hyperandrogenism
Interventions Drug: Flutamide
Drug: Progesterone
Drug: estrace
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Flutamide, Estrace, Progesterone
Hide Arm/Group Description

For flutamide, subjects weighing > 50 kg will receive 250 mg orally twice a day, and subjects weighing < 50 kg will receive 125 mg orally twice a day for approximately 3 weeks.

Subjects will be given oral estrace, 0.5-1 mg once a day for 7 days following the first overnight study admission.

Subjects will be given oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days following the first overnight study admission.

Flutamide: Subjects weighing > 50 kg will receive 250 mg orally twice a day, and subjects weighing < 50 kg will receive 125 mg orally twice a day.

Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days

estrace: 0.5-1 mg once a day for seven days

Period Title: Overall Study
Started 4
Completed 2
Not Completed 2
Reason Not Completed
Physician Decision             1
Elevated screening liver enzymes             1
Arm/Group Title Flutamide, Estrace, Progesterone
Hide Arm/Group Description

For flutamide, subjects weighing > 50 kg will receive 250 mg orally twice a day, and subjects weighing < 50 kg will receive 125 mg orally twice a day for approximately 3 weeks.

Subjects will be given oral estrace, 0.5-1 mg once a day for 7 days following the first overnight study admission.

Subjects will be given oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days following the first overnight study admission.

Flutamide: Subjects weighing > 50 kg will receive 250 mg orally twice a day, and subjects weighing < 50 kg will receive 125 mg orally twice a day.

Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days

estrace: 0.5-1 mg once a day for seven days

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
4
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
[1]
Measure Description: Age, Sex/Gender, Race, Ethnicity
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
15.5
(14 to 17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
4
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 4 participants
4
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
 100.0%
1.Primary Outcome
Title Slope of the Percent Change in Luteinizing Hormone (LH) Pulses as a Function of Day 7 Progesterone Level
Hide Description The primary outcome variable for the study is the slope of the percent change in LH pulses as a function of day 7 progesterone level.
Time Frame 3 weeks after flutamide treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject completed the study but had not taken the study medication so her data is unusable. The second subject completed the study. However, no data were formally analyzed. We were subsequently unable to recruit any additional subjects.
Arm/Group Title Flutamide, Estrace, Progesterone
Hide Arm/Group Description:

For flutamide, subjects weighing > 50 kg will receive 250 mg orally twice a day, and subjects weighing < 50 kg will receive 125 mg orally twice a day for approximately 3 weeks.

Subjects will be given oral estrace, 0.5-1 mg once a day for 7 days following the first overnight study admission.

Subjects will be given oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days following the first overnight study admission.

Flutamide: Subjects weighing > 50 kg will receive 250 mg orally twice a day, and subjects weighing < 50 kg will receive 125 mg orally twice a day.

Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days

estrace: 0.5-1 mg once a day for seven days

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: percentage of slope change
-0.55
Time Frame Two weeks post study drug intervention, at time of last blood draw.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Flutamide, Estrace, Progesterone
Hide Arm/Group Description

For flutamide, subjects weighing > 50 kg will receive 250 mg orally twice a day, and subjects weighing < 50 kg will receive 125 mg orally twice a day for approximately 3 weeks.

Subjects will be given oral estrace, 0.5-1 mg once a day for 7 days following the first overnight study admission.

Subjects will be given oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days following the first overnight study admission.

Flutamide: Subjects weighing > 50 kg will receive 250 mg orally twice a day, and subjects weighing < 50 kg will receive 125 mg orally twice a day.

Progesterone: oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days

estrace: 0.5-1 mg once a day for seven days

All-Cause Mortality
Flutamide, Estrace, Progesterone
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Flutamide, Estrace, Progesterone
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Flutamide, Estrace, Progesterone
Affected / at Risk (%)
Total   1/4 (25.00%) 
Social circumstances   
Mood change, sadness *  1/4 (25.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Clinical Research Coordinator
Organization: University of Virginia
Phone: 434-243-6911
Responsible Party: John Marshall, University of Virginia
ClinicalTrials.gov Identifier: NCT01428193     History of Changes
Other Study ID Numbers: 12632
U54HD028934-18 ( U.S. NIH Grant/Contract )
First Submitted: August 29, 2011
First Posted: September 2, 2011
Results First Submitted: September 8, 2017
Results First Posted: June 4, 2018
Last Update Posted: June 4, 2018