Adults 18 to 35, female only, with Normal or PCOS. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
LH Pulse FrequencyPrimary· 10 hours before and after administration of micronized progesterone and placebo
The primary endpoint is the change in the number of LH pulses (over 10 hours) attributable to progesterone.
Placebo 20:00-06:00 (pre-pbo)
Group
Value
95% CI
PCOS Women
1.31
1.01 – 1.88
Normal Controls
0.91
0.81 – 1.44
Placebo 10:00-20:00 (post-pbo)
Group
Value
95% CI
PCOS Women
1.33
1.24 – 1.85
Normal Controls
1.19
1.04 – 1.52
Progesterone 20:00-06:00 (pre-P4)
Group
Value
95% CI
PCOS Women
0.99
0.80 – 1.85
Normal Controls
0.98
0.86 – 1.44
Progesterone 10:00-20:00 (post-P4)
Group
Value
95% CI
PCOS Women
1.18
.97 – 1.76
Normal Controls
1.05
1.01 – 1.44
Mean LHSecondary· 10 hours before and after administration of micronized progesterone and placebo
A secondary endpoint is the change in mean LH concentration (over 10 hours) attributable to progesterone.
Placebo 20:00-06:00 (pre-pbo)
Group
Value
95% CI
PCOS Women
8.2
7.8 – 34.4
Normal Controls
6.4
3.9 – 10.3
Placebo 10:00-20:00 (post-pbo)
Group
Value
95% CI
PCOS Women
12.0
9.6 – 36.0
Normal Controls
8.8
7.1 – 16.5
Progesterone 20:00-06:00 (pre-P4)
Group
Value
95% CI
PCOS Women
8.6
7.6 – 18.1
Normal Controls
5.6
2.5 – 17.6
Progesterone 10:00-20:00 (post-P4)
Group
Value
95% CI
PCOS Women
26.6
20.9 – 50.0
Normal Controls
20.7
10.6 – 54.9
LH Pulse MassSecondary· 10 hours before and after administration of micronized progesterone and placebo
A secondary endpoint is the change in LH pulse mass (a correlate of LH pulse amplitude) attributable to progesterone.
Placebo 20:00-06:00 (pre-pbo)
Group
Value
95% CI
PCOS Women
3.6
2.5 – 6.7
Normal Controls
4.85
4.0 – 13.6
Placebo 10:00-20:00 (post-pbo)
Group
Value
95% CI
PCOS Women
4.3
2.9 – 8.2
Normal Controls
7.51
5.3 – 26.4
Progesterone 20:00-06:00 (pre-p4)
Group
Value
95% CI
PCOS Women
3.6
1.7 – 11.1
Normal Controls
5.47
3.8 – 15.8
Progesterone 10:00-20:00 (post-p4)
Group
Value
95% CI
PCOS Women
13.9
7.5 – 32.2
Normal Controls
13.96
9.3 – 35.4
Mean FSHSecondary· 10 hours before and after administration of micronized progesterone and placebo
A secondary endpoint is the change in mean FSH concentration (over 10 hours) attributable to progesterone.
Placebo 20:00-06:00 (pre-pbo)
Group
Value
95% CI
PCOS Women
4.5
3.0 – 6.3
Normal Controls
3.5
3.1 – 5.4
Placebo 10:00-20:00 (post-pbo)
Group
Value
95% CI
PCOS Women
3.9
3.3 – 9.0
Normal Controls
4.5
3.8 – 7.0
Progesterone 20:00-06:00 (pre-p4)
Group
Value
95% CI
PCOS Women
4.2
3.0 – 6.4
Normal Controls
4.4
2.5 – 5.9
Progesterone 10:00-20:00 (post-p4)
Group
Value
95% CI
PCOS Women
6.3
4.4 – 9.1
Normal Controls
8.0
5.63 – 14.6
Adverse events — posted to ClinicalTrials.gov
Time frame: 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..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The rapidity with which progesterone (P) suppresses daytime lutenizing hormone (LH) (and by inference gonadotropin releasing hormone (GnRH)) pulse frequency is unknown. We propose to assess this further using a randomized, cross-over, placebo-controlled study. Ovulatory women will begin E2 patches on day 4-8 of the cycle, while women with PCOS will begin E2 patches either on day 4-8 of the cycle or at least 8 weeks post-menses. After 3 d of E2 administration, women will undergo a 24-h sampling study in the GCRC. Beginning at 2000 h, blood for LH, FSH, E2, P, and T will be obtained over a 24-h period. After 10 h of sampling, either oral micronized P (100 mg p.o.) suspension or placebo suspension will be administered (according to randomization). At the completion of sampling, E2 patches will be discontinued. During a subsequent menstrual cycle (or after at least 3 weeks in oligomenorrheic PCOS), subjects will undergo another GCRC study identical to the first (including pretreatment with E2) except that oral P will be exchanged for placebo or vice versa in accordance with the crossover design. We will assess the acute effects of progesterone on LH frequency, with secondary endpoints being mean LH, LH pulse amplitude, and mean follicle-stimulating hormone (FSH). We propose two primary hypotheses: (1) administration of P (at 0600 h) to normally cycling adult women during the follicular phase will result in a demonstrable suppression of daytime LH (and by inference GnRH) pulse frequency within 12 hours; (2) administration of P (at 0600 h) to women with PCOS will result in less suppression of daytime LH pulse frequency than in ovulatory women without PCOS. A secondary hypothesis is that augmentation of LH amplitude after P administration will be less in PCOS compared to normal controls.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07055152 — Retinal OCTA for Microvascular Dysfunction Evaluation and Outcome Prediction in MINOCA Patients
· recruiting
Other University of Virginia trials
Trials by the same sponsor.
NCT05880355 — Multimodality Cardiovascular Imaging for the Translation of Therapies for Vascular Activation After MI
· EARLY_PHASE1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Virginia
Last refreshed: 28 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00594217.