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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 is a Phase 1 study that was terminated before completion, run by University of Virginia. The registered enrollment target is 12 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01602679
The ClinicalTrials.gov registry entry for NCT01602679 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01602679 reports 0 study locations.
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.
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