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NCT01602679 · ClinicalTrials.gov registry record · Phase 1
Acute Effects of Progesterone on LH Pulses During the Follicular Phase (CRM006)
A Phase 1 study, sponsored by University of Virginia.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01602679: Clinical Trial Phase 1 study, sponsored by University of Virginia.
NCT01602679 is a Phase 1 study that was terminated before completion, run by University of Virginia. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01602679, a Phase 1 study, was terminated before completion, sponsored by University of Virginia.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The rapidity with which progesterone slows LH (and by inference GnRH) pulse frequency in women is unclear. The investigators hypothesize that progesterone slows LH pulse frequency within 10 hours. The investigators propose to assess this further with a randomized, cross-over, placebo-controlled study. Regularly cycling women without hyperandrogenism will be admitted to the Clinical Research Unit on cycle day 5-9 (mid-follicular phase) for a 10 hour frequent sampling study to observe LH, FSH, estradiol, progesterone, and testosterone. Either oral micronized progesterone suspension or placebo will be administered at 0900 h. During a subsequent menstrual cycle, subjects will undergo another study identical to the first except that oral progesterone will be exchanged for placebo or vice versa in accordance with a crossover design.
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG oral micronized progesterone suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-07-31 |
| Phase | Phase 1 |
Why NCT01602679 stopped before completion
NCT01602679 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01602679 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01602679 about?
NCT01602679 is a clinical study titled "Acute Effects of Progesterone on LH Pulses During the Follicular Phase (CRM006)". The rapidity with which progesterone slows LH (and by inference GnRH) pulse frequency in women is unclear. The investigators hypothesize that progesterone slows LH pulse frequency within 10 hours. The investigators propose to assess this further with a randomized, cross-over, placebo-controlled stud...
What is the current status of trial NCT01602679?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2012-05. Estimated completion is 2015-07-31.
What interventions are being tested in trial NCT01602679?
The interventions under investigation include: Placebo (DRUG), oral micronized progesterone suspension (DRUG).
Who is sponsoring clinical trial NCT01602679?
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 NCT01602679's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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
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