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NCT00160199 · ClinicalTrials.gov registry record · Phase 4
Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion
A Phase 4 study, sponsored by Solvay Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 240
- Enrollment target
NCT00160199: Completed Phase 4 study, sponsored by Solvay Pharmaceuticals.
NCT00160199 is a Phase 4 study that has completed, run by Solvay Pharmaceuticals. The registered enrollment target is 240 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00160199, a Phase 4 study, has completed, sponsored by Solvay Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 240 participants
- Enrollment target
Study Summary
To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in women of reproductive age with secondary amenorrhea
Primary Outcome
Endometrial biopsy results were classified as : Secretory (Complete or partial), Non-secretory, Unable to determine or Unknown after an evaluation of morphologic criteria.
Interventions
- DRUG PROMETRIUM® 300 mg
- DRUG PROMETRIUM® 400 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2004-11 |
| Est. Completion | 2009-02 |
| Phase | Phase 4 |
What the finished NCT00160199 record still lists
NCT00160199 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 2 interventions - of which PROMETRIUM® 300 mg is the first listed.
NCT00160199 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00160199 about?
NCT00160199 is a clinical study titled "Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion". To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in women of reproductive age with secondary amenorrhea
What is the current status of trial NCT00160199?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 240 participants. The study started on 2004-11. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00160199?
The interventions under investigation include: PROMETRIUM® 300 mg (DRUG), PROMETRIUM® 400 mg (DRUG).
Who is sponsoring clinical trial NCT00160199?
This trial is sponsored by Solvay Pharmaceuticals, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00160199's enrollment target sits among peer trials
240 360th of 2000 higher than 1,635 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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