Trial Outcomes & Findings for Determining How Quickly Progesterone Slows LH Pulse Frequency (NCT NCT00594217)
NCT ID: NCT00594217
Last Updated: 2025-03-28
Results Overview
The primary endpoint is the change in the number of LH pulses (over 10 hours) attributable to progesterone.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
85 participants
Primary outcome timeframe
10 hours before and after administration of micronized progesterone and placebo
Results posted on
2025-03-28
Participant Flow
85 subjects enrolled in this study. 29 women initiated formal study procedures. However, for personal reasons, 4 women dropped out of the study after completing only 1 admission. In addition, data from one woman was excluded from analysis because her study was unintentionally performed during the luteal phase. Thus, data for 24 women were formally analyzed. 56 women were withdrawn from study prior to being assigned to an arm of intervention.
Participant milestones
| Measure |
PCOS Women
PCOS women: women were considered to have PCOS if they had evidence of clinical and/or biochemical hyperandrogenism plus oligo-amenorrhea in the absence of other identifiable causes.
|
Normal Controls
Normal controls: non-PCOS women with regular menstrual cycles and without evidence of hyperandrogenism.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
16
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
PCOS Women
PCOS women: women were considered to have PCOS if they had evidence of clinical and/or biochemical hyperandrogenism plus oligo-amenorrhea in the absence of other identifiable causes.
|
Normal Controls
Normal controls: non-PCOS women with regular menstrual cycles and without evidence of hyperandrogenism.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Determining How Quickly Progesterone Slows LH Pulse Frequency
Baseline characteristics by cohort
| Measure |
PCOS Women
n=12 Participants
PCOS women: women were considered to have PCOS if they had evidence of clinical and/or biochemical hyperandrogenism plus oligo-/amenorrhea in the absence of other identifiable causes.
oral micronized progesterone suspension: oral micronized progesterone suspension, single 100 mg oral dose
Placebo: Placebo contains only inert ingredients and is not expected to exert any direct physiological effects
|
Normal Controls
n=12 Participants
Normal control women: women with regular menstrual cycles without evidence of hyperandrogenism.
oral micronized progesterone suspension: oral micronized progesterone suspension, single 100 mg oral dose
Placebo: Placebo contains only inert ingredients and is not expected to exert any direct physiological effects
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
12 participants
n=107 Participants
|
24 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 10 hours before and after administration of micronized progesterone and placeboThe primary endpoint is the change in the number of LH pulses (over 10 hours) attributable to progesterone.
Outcome measures
| Measure |
PCOS Women
n=12 Participants
PCOS women: women were considered to have PCOS if they had evidence of clinical and/or biochemical hyperandrogenism plus oligo-amenorrhea in the absence of other identifiable causes.
|
Normal Controls
n=12 Participants
Normal controls: non-PCOS women with regular menstrual cycles and without evidence of hyperandrogenism.
|
|---|---|---|
|
LH Pulse Frequency
Placebo 20:00-06:00 (pre-pbo)
|
1.31 pulses/hour
Interval 1.01 to 1.88
|
0.91 pulses/hour
Interval 0.81 to 1.44
|
|
LH Pulse Frequency
Placebo 10:00-20:00 (post-pbo)
|
1.33 pulses/hour
Interval 1.24 to 1.85
|
1.19 pulses/hour
Interval 1.04 to 1.52
|
|
LH Pulse Frequency
Progesterone 20:00-06:00 (pre-P4)
|
0.99 pulses/hour
Interval 0.8 to 1.85
|
0.98 pulses/hour
Interval 0.86 to 1.44
|
|
LH Pulse Frequency
Progesterone 10:00-20:00 (post-P4)
|
1.18 pulses/hour
Interval 0.97 to 1.76
|
1.05 pulses/hour
Interval 1.01 to 1.44
|
SECONDARY outcome
Timeframe: 10 hours before and after administration of micronized progesterone and placeboA secondary endpoint is the change in mean LH concentration (over 10 hours) attributable to progesterone.
Outcome measures
| Measure |
PCOS Women
n=12 Participants
PCOS women: women were considered to have PCOS if they had evidence of clinical and/or biochemical hyperandrogenism plus oligo-amenorrhea in the absence of other identifiable causes.
|
Normal Controls
n=12 Participants
Normal controls: non-PCOS women with regular menstrual cycles and without evidence of hyperandrogenism.
|
|---|---|---|
|
Mean LH
Placebo 20:00-06:00 (pre-pbo)
|
8.2 IU/L
Interval 7.8 to 34.4
|
6.4 IU/L
Interval 3.9 to 10.3
|
|
Mean LH
Placebo 10:00-20:00 (post-pbo)
|
12.0 IU/L
Interval 9.6 to 36.0
|
8.8 IU/L
Interval 7.1 to 16.5
|
|
Mean LH
Progesterone 20:00-06:00 (pre-P4)
|
8.6 IU/L
Interval 7.6 to 18.1
|
5.6 IU/L
Interval 2.5 to 17.6
|
|
Mean LH
Progesterone 10:00-20:00 (post-P4)
|
26.6 IU/L
Interval 20.9 to 50.0
|
20.7 IU/L
Interval 10.6 to 54.9
|
SECONDARY outcome
Timeframe: 10 hours before and after administration of micronized progesterone and placeboA secondary endpoint is the change in LH pulse mass (a correlate of LH pulse amplitude) attributable to progesterone.
Outcome measures
| Measure |
PCOS Women
n=12 Participants
PCOS women: women were considered to have PCOS if they had evidence of clinical and/or biochemical hyperandrogenism plus oligo-amenorrhea in the absence of other identifiable causes.
|
Normal Controls
n=12 Participants
Normal controls: non-PCOS women with regular menstrual cycles and without evidence of hyperandrogenism.
|
|---|---|---|
|
LH Pulse Mass
Placebo 20:00-06:00 (pre-pbo)
|
3.6 IU/L
Interval 2.5 to 6.7
|
4.85 IU/L
Interval 4.0 to 13.6
|
|
LH Pulse Mass
Placebo 10:00-20:00 (post-pbo)
|
4.3 IU/L
Interval 2.9 to 8.2
|
7.51 IU/L
Interval 5.3 to 26.4
|
|
LH Pulse Mass
Progesterone 20:00-06:00 (pre-p4)
|
3.6 IU/L
Interval 1.7 to 11.1
|
5.47 IU/L
Interval 3.8 to 15.8
|
|
LH Pulse Mass
Progesterone 10:00-20:00 (post-p4)
|
13.9 IU/L
Interval 7.5 to 32.2
|
13.96 IU/L
Interval 9.3 to 35.4
|
SECONDARY outcome
Timeframe: 10 hours before and after administration of micronized progesterone and placeboA secondary endpoint is the change in mean FSH concentration (over 10 hours) attributable to progesterone.
Outcome measures
| Measure |
PCOS Women
n=12 Participants
PCOS women: women were considered to have PCOS if they had evidence of clinical and/or biochemical hyperandrogenism plus oligo-amenorrhea in the absence of other identifiable causes.
|
Normal Controls
n=12 Participants
Normal controls: non-PCOS women with regular menstrual cycles and without evidence of hyperandrogenism.
|
|---|---|---|
|
Mean FSH
Placebo 10:00-20:00 (post-pbo)
|
3.9 IU/L
Interval 3.3 to 9.0
|
4.5 IU/L
Interval 3.8 to 7.0
|
|
Mean FSH
Placebo 20:00-06:00 (pre-pbo)
|
4.5 IU/L
Interval 3.0 to 6.3
|
3.5 IU/L
Interval 3.1 to 5.4
|
|
Mean FSH
Progesterone 20:00-06:00 (pre-p4)
|
4.2 IU/L
Interval 3.0 to 6.4
|
4.4 IU/L
Interval 2.5 to 5.9
|
|
Mean FSH
Progesterone 10:00-20:00 (post-p4)
|
6.3 IU/L
Interval 4.4 to 9.1
|
8.0 IU/L
Interval 5.63 to 14.6
|
Adverse Events
PCOS Women
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Normal Controls
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PCOS Women
n=13 participants at risk
PCOS women: women were considered to have PCOS if they had evidence of clinical and/or biochemical hyperandrogenism plus oligo-amenorrhea in the absence of other identifiable causes.
|
Normal Controls
n=16 participants at risk
Normal controls: non-PCOS women with regular menstrual cycles and without evidence of hyperandrogenism.
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
7.7%
1/13 • Adverse event data were collected beginning after subjects began study drug/intervention/study-related procedures/specimen collection up until the end of the study drug/intervention/participation; an average of 6 months.
|
0.00%
0/16 • Adverse event data were collected beginning after subjects began study drug/intervention/study-related procedures/specimen collection up until the end of the study drug/intervention/participation; an average of 6 months.
|
|
Reproductive system and breast disorders
Spotting
|
0.00%
0/13 • Adverse event data were collected beginning after subjects began study drug/intervention/study-related procedures/specimen collection up until the end of the study drug/intervention/participation; an average of 6 months.
|
12.5%
2/16 • Adverse event data were collected beginning after subjects began study drug/intervention/study-related procedures/specimen collection up until the end of the study drug/intervention/participation; an average of 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
7.7%
1/13 • Adverse event data were collected beginning after subjects began study drug/intervention/study-related procedures/specimen collection up until the end of the study drug/intervention/participation; an average of 6 months.
|
0.00%
0/16 • Adverse event data were collected beginning after subjects began study drug/intervention/study-related procedures/specimen collection up until the end of the study drug/intervention/participation; an average of 6 months.
|
|
General disorders
fatigue
|
7.7%
1/13 • Adverse event data were collected beginning after subjects began study drug/intervention/study-related procedures/specimen collection up until the end of the study drug/intervention/participation; an average of 6 months.
|
0.00%
0/16 • Adverse event data were collected beginning after subjects began study drug/intervention/study-related procedures/specimen collection up until the end of the study drug/intervention/participation; an average of 6 months.
|
|
Skin and subcutaneous tissue disorders
swelling at IV site
|
0.00%
0/13 • Adverse event data were collected beginning after subjects began study drug/intervention/study-related procedures/specimen collection up until the end of the study drug/intervention/participation; an average of 6 months.
|
6.2%
1/16 • Adverse event data were collected beginning after subjects began study drug/intervention/study-related procedures/specimen collection up until the end of the study drug/intervention/participation; an average of 6 months.
|
Additional Information
Dr. Christopher R. McCartney
University of Virginia Center for Research in Reproduction
Phone: 4342436911
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place