Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00594217 · ClinicalTrials.gov registry record · Phase 1
Determining How Quickly Progesterone Slows LH Pulse Frequency
A Phase 1 study, sponsored by University of Virginia.
- Completed
- Registry status
- Phase 1
- Development phase
- 85
- Enrollment target
NCT00594217: Completed Phase 1 study, sponsored by University of Virginia.
NCT00594217 is a Phase 1 study that has completed, run by University of Virginia. The registered enrollment target is 85 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00594217, a Phase 1 study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 85 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The primary endpoint is the change in the number of LH pulses (over 10 hours) attributable to progesterone.
Interventions
- OTHER Placebo
- DRUG oral micronized progesterone suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2007-11-29 |
| Est. Completion | 2020-01-18 |
| Phase | Phase 1 |
What the finished NCT00594217 record still lists
NCT00594217 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00594217 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00594217 about?
NCT00594217 is a clinical study titled "Determining How Quickly Progesterone Slows LH Pulse Frequency". 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 o...
What is the current status of trial NCT00594217?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2007-11-29. Estimated completion is 2020-01-18.
What interventions are being tested in trial NCT00594217?
The interventions under investigation include: Placebo (OTHER), oral micronized progesterone suspension (DRUG).
Who is sponsoring clinical trial NCT00594217?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00594217's enrollment target sits among peer trials
85 656th of 2000 higher than 1,342 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00842283 · 85 participants
Role of Angiogenesis in Dermatologic Diseases: A Potential Therapeutic Target
- NCT02133196 · 85 participants · Phase 2
T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer
- NCT03823144 · 85 participants · NA
Intravital Microscopy in Human Solid Tumors
- NCT03875638 · 85 participants · Phase 2
Treating Hyperexcitability in AD With Levetiracetam
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI