Trial Outcomes & Findings for Acute Effects of Progesterone on LH Pulses During the Follicular Phase (CRM006) (NCT NCT01602679)
NCT ID: NCT01602679
Last Updated: 2018-10-16
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
10 hours following administration of micronized progesterone or placebo
Results posted on
2018-10-16
Participant Flow
12 subjects enrolled in this study. 5 subjects completed screening procedures only (these 5 subjects were withdrawn from study prior to being assigned to an arm of intervention).
Participant milestones
| Measure |
Oral Micronized Progesterone Suspension, Then Placebo
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, Then Oral Micronized Progesterone 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
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acute Effects of Progesterone on LH Pulses During the Follicular Phase (CRM006)
Baseline characteristics by cohort
| Measure |
Oral Micronized Progesterone Suspension, Then Placebo
n=4 Participants
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
|
Placebo, Then Oral Micronized Progesterone Suspension
n=3 Participants
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
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 hours following administration of micronized progesterone or placeboThe 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
Outcome measures
| Measure |
Oral Micronized Progesterone Suspension
n=7 Participants
oral micronized progesterone (100 mg p.o.) suspension
oral micronized progesterone suspension: oral micronized progesterone (100 mg p.o.) suspension
|
Placebo
n=7 Participants
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
|
|---|---|---|
|
Change in Number of LH Pulses Per Hour
|
0.77 pulses/h
Standard Deviation 0.28
|
0.79 pulses/h
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: 10 hours following administration of micronized progesterone or placeboThis 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
Outcome measures
| Measure |
Oral Micronized Progesterone Suspension
n=7 Participants
oral micronized progesterone (100 mg p.o.) suspension
oral micronized progesterone suspension: oral micronized progesterone (100 mg p.o.) suspension
|
Placebo
n=7 Participants
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
|
|---|---|---|
|
Change in Mean LH
|
5.8 IU/L
Standard Deviation 2.2
|
4.6 IU/L
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 10 hours following administration of micronized progesterone or placeboThis 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
Outcome measures
| Measure |
Oral Micronized Progesterone Suspension
n=7 Participants
oral micronized progesterone (100 mg p.o.) suspension
oral micronized progesterone suspension: oral micronized progesterone (100 mg p.o.) suspension
|
Placebo
n=7 Participants
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
|
|---|---|---|
|
Change in Mean LH Amplitude
|
4.3 IU/L
Standard Deviation 2.8
|
3.6 IU/L
Standard Deviation 2.8
|
Adverse Events
Oral Micronized Progesterone Suspension
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oral Micronized Progesterone Suspension
n=4 participants at risk
Oral micronized progesterone (100 mg) suspension
|
Placebo
n=3 participants at risk
Placebo contains only inert ingredients and is not expected to exert any direct physiological effects
|
|---|---|---|
|
Reproductive system and breast disorders
Irregular Menstrual Bleeding
|
25.0%
1/4 • Number of events 1 • From start of study procedures until end of study participation, up to 6 months
|
0.00%
0/3 • From start of study procedures until end of study participation, up to 6 months
|
Additional Information
Dr. Christopher R. McCartney
University of Virginia Center for Research in Reproduction
Phone: 4342430329
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place