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Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition (JCM026)

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ClinicalTrials.gov Identifier: NCT01428245
Recruitment Status : Terminated (The research questions was changed/de-prioritized. Only one subject completed.)
First Posted : September 2, 2011
Results First Posted : December 30, 2020
Last Update Posted : December 30, 2020
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 Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Hyperandrogenemia
Polycystic Ovary Syndrome
Interventions Drug: Progesterone
Drug: Estrace (estrogen)
Enrollment 3
Recruitment Details  
Pre-assignment Details 3 subjects enrolled in this study. 2 subjects completed screening procedures only (these 2 subjects were withdrawn from study prior to being assigned to an arm of intervention).
Arm/Group Title Progesterone, Estrace
Hide Arm/Group Description

oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr to achieve mean plasma concentrations over the range of 2-8 ng/ml for seven days

oral estrace, 0.5-1 mg once a day for seven days

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

Estrace (estrogen): oral estrace, 0.5-1 mg once a day for seven days

Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Progesterone, Estrace
Hide Arm/Group Description

oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr to achieve mean plasma concentrations over the range of 2-8 ng/ml for seven days

oral estrace, 0.5-1 mg once a day for seven days

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

Estrace (estrogen): oral estrace, 0.5-1 mg once a day for seven days

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
1
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
1
 100.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title LH Pulse Frequency as a Function of Day 7 Progesterone
Hide Description number of LH pulses per 11 hours on Day 7 of progesterone
Time Frame 7 days following oral estrace and progesterone administration
Hide Outcome Measure Data
Hide Analysis Population Description
Only one subject completed study.
Arm/Group Title Progesterone, Estrace
Hide Arm/Group Description:

oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr to achieve mean plasma concentrations over the range of 2-8 ng/ml for seven days

oral estrace, 0.5-1 mg once a day for seven days

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

Estrace (estrogen): oral estrace, 0.5-1 mg once a day for seven days

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: number of LH pulses/11hr
0
Time Frame 30 days post study drug intervention
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Progesterone, Estrace
Hide Arm/Group Description

oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr to achieve mean plasma concentrations over the range of 2-8 ng/ml for seven days

oral estrace, 0.5-1 mg once a day for seven days

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

Estrace (estrogen): oral estrace, 0.5-1 mg once a day for seven days

All-Cause Mortality
Progesterone, Estrace
Affected / at Risk (%)
Total   0/1 (0.00%) 
Hide Serious Adverse Events
Progesterone, Estrace
Affected / at Risk (%)
Total   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Progesterone, Estrace
Affected / at Risk (%)
Total   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Research Coordinator
Organization: University of Virginia
Phone: 434-243-6911
EMail: pcos@virginia.edu
Layout table for additonal information
Responsible Party: John Marshall, University of Virginia
ClinicalTrials.gov Identifier: NCT01428245    
Other Study ID Numbers: 14100
U54HD028934 ( U.S. NIH Grant/Contract )
P50HD028934 ( U.S. NIH Grant/Contract )
First Submitted: August 31, 2011
First Posted: September 2, 2011
Results First Submitted: November 10, 2020
Results First Posted: December 30, 2020
Last Update Posted: December 30, 2020