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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Flutamide, Estrace, Progesterone

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


Participant Flow:   Overall Study
    Flutamide, Estrace, Progesterone
STARTED   4 
COMPLETED   2 
NOT COMPLETED   2 
Physician Decision                1 
Elevated screening liver enzymes                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Flutamide, Estrace, Progesterone

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


Baseline Measures
   Flutamide, Estrace, Progesterone 
Overall Participants Analyzed 
[Units: Participants]
 4 
Age [1] 
[Units: Participants]
Count of Participants
 
<=18 years      4 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
[1] Age, Sex/Gender, Race, Ethnicity
Age 
[Units: Years]
Mean (Full Range)
 15.5 
 (14 to 17) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4 100.0% 
Male      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
White   4 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   4 


  Outcome Measures

1.  Primary:   Slope of the Percent Change in Luteinizing Hormone (LH) Pulses as a Function of Day 7 Progesterone Level   [ Time Frame: 3 weeks after flutamide treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: pcos@virginia.edu



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