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Acute Effects of Progesterone on LH Pulses During the Follicular Phase (CRM006)

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ClinicalTrials.gov Identifier: NCT01602679
Recruitment Status : Terminated (Interim analysis suggested futility.)
First Posted : May 21, 2012
Results First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Chris McCartney, University of Virginia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Female Reproductive Physiology
Interventions Drug: oral micronized progesterone suspension
Drug: Placebo
Enrollment 12
Recruitment Details  
Pre-assignment Details 12 subjects enrolled in this study. 5 subjects completed screening procedures only (these 5 subjects were withdrawn from study prior to being assigned to an arm of intervention).
Arm/Group Title Oral Micronized Progesterone Suspension, Then Placebo Placebo, Then Oral Micronized Progesterone Suspension
Hide Arm/Group Description

Participants first received oral micronized progesterone (100 mg p.o.) suspension. After a washout period of approximately 20 days, they then received placebo.

oral micronized progesterone suspension: oral micronized progesterone (100 mg p.o.) suspension

Participants first received Placebo. After a washout period of approximately 20 days, they then received oral micronized progesterone suspension. Placebo contains only inert ingredients and is not expected to exert any direct physiological effects

Placebo: Placebo contains only inert ingredients and is not expected to exert any direct physiological effects

Period Title: Overall Study
Started 4 3
Completed 4 3
Not Completed 0 0
Arm/Group Title Oral Micronized Progesterone Suspension, Then Placebo Placebo, Then Oral Micronized Progesterone Suspension Total
Hide Arm/Group Description

Participants first received oral micronized progesterone (100 mg p.o.) suspension. After a washout period of approximately 20 days, they then received Placebo.

oral micronized progesterone suspension: oral micronized progesterone (100 mg p.o.) suspension Placebo: Placebo contains only inert ingredients and is not expected to exert any direct physiological effects

Participants first received Placebo. After a washout period of approximately 20 days, they then received oral micronized progesterone suspension. Placebo contains only inert ingredients and is not expected to exert any direct physiological effects

Placebo: Placebo contains only inert ingredients and is not expected to exert any direct physiological effects oral micronized progesterone suspension: oral micronized progesterone (100 mg p.o.) suspension

Total of all reporting groups
Overall Number of Baseline Participants 4 3 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
3
 100.0%
7
 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 4 participants 3 participants 7 participants
Female
4
 100.0%
3
 100.0%
7
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
 100.0%
3
 100.0%
7
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 3 participants 7 participants
4 3 7
1.Primary Outcome
Title Change in Number of LH Pulses Per Hour
Hide Description The primary endpoint is the change in the number of LH pulses per hour (over 10 h), comparing (a) number of LH pulses at baseline to (b) number of LH pulses immediately after progesterone or placebo administration
Time Frame 10 hours following administration of micronized progesterone or placebo
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Micronized Progesterone Suspension Placebo
Hide Arm/Group Description:

oral micronized progesterone (100 mg p.o.) suspension

oral micronized progesterone suspension: oral micronized progesterone (100 mg p.o.) suspension

Placebo contains only inert ingredients and is not expected to exert any direct physiological effects

Placebo: Placebo contains only inert ingredients and is not expected to exert any direct physiological effects

Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: pulses/h
0.77  (0.28) 0.79  (0.35)
2.Secondary Outcome
Title Change in Mean LH
Hide Description This secondary endpoint is the change of the mean LH (over 10 h), comparing (a) mean LH at baseline to (b) mean LH immediately after progesterone or placebo administration
Time Frame 10 hours following administration of micronized progesterone or placebo
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Micronized Progesterone Suspension Placebo
Hide Arm/Group Description:

oral micronized progesterone (100 mg p.o.) suspension

oral micronized progesterone suspension: oral micronized progesterone (100 mg p.o.) suspension

Placebo contains only inert ingredients and is not expected to exert any direct physiological effects

Placebo: Placebo contains only inert ingredients and is not expected to exert any direct physiological effects

Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: IU/L
5.8  (2.2) 4.6  (2.3)
3.Secondary Outcome
Title Change in Mean LH Amplitude
Hide Description This secondary endpoint is the change in the mean LH amplitude (over 10 h), comparing (a) mean LH amplitude at baseline to (b) mean LH amplitude immediately after progesterone or placebo administration
Time Frame 10 hours following administration of micronized progesterone or placebo
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Micronized Progesterone Suspension Placebo
Hide Arm/Group Description:

oral micronized progesterone (100 mg p.o.) suspension

oral micronized progesterone suspension: oral micronized progesterone (100 mg p.o.) suspension

Placebo contains only inert ingredients and is not expected to exert any direct physiological effects

Placebo: Placebo contains only inert ingredients and is not expected to exert any direct physiological effects

Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: IU/L
4.3  (2.8) 3.6  (2.8)
Time Frame From start of study procedures until end of study participation, up to 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oral Micronized Progesterone Suspension Placebo
Hide Arm/Group Description Oral micronized progesterone (100 mg) suspension Placebo contains only inert ingredients and is not expected to exert any direct physiological effects
All-Cause Mortality
Oral Micronized Progesterone Suspension Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/3 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Oral Micronized Progesterone Suspension Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oral Micronized Progesterone Suspension Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      0/3 (0.00%)    
Reproductive system and breast disorders     
Irregular Menstrual Bleeding * [1]  1/4 (25.00%)  1 0/3 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Temporary spotting
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: Dr. Christopher R. McCartney
Organization: University of Virginia Center for Research in Reproduction
Phone: 4342430329
Responsible Party: Chris McCartney, University of Virginia
ClinicalTrials.gov Identifier: NCT01602679     History of Changes
Other Study ID Numbers: 16085
R01HD058671 ( U.S. NIH Grant/Contract )
First Submitted: May 17, 2012
First Posted: May 21, 2012
Results First Submitted: July 31, 2018
Results First Posted: October 16, 2018
Last Update Posted: October 16, 2018