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NCT03380091 · ClinicalTrials.gov registry record · Phase 4
Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial
A Phase 4 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT03380091: Clinical Trial Phase 4 study, sponsored by University of California, San Francisco.
NCT03380091 is a Phase 4 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 5 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03380091, a Phase 4 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study Summary
Open-label randomized clinical trial assessing the efficacy of Metformin versus Vitamin D in improving symptoms of depressed mood in polycystic ovary syndrome.
Primary Outcome
BDI-II is a validated self-reported instrument of 21 questions which are each scored 0-3. Total scores range from 0-63, with higher score totals indicating more severe depression symptoms. {0-9: indicates minimal depression; 0-18: indicates mild depression; 19-29: indicates moderate depression; 30-63: indicates severe depression}. Change = Week 12 total score - Baseline week score
Interventions
- DRUG Metformin
- DRUG Vitamin D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2017-12-12 |
| Est. Completion | 2019-09-01 |
| Phase | Phase 4 |
Why NCT03380091 stopped before completion
NCT03380091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Metformin is the first listed.
NCT03380091 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03380091 about?
NCT03380091 is a clinical study titled "Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial". Open-label randomized clinical trial assessing the efficacy of Metformin versus Vitamin D in improving symptoms of depressed mood in polycystic ovary syndrome.
What is the current status of trial NCT03380091?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2017-12-12. Estimated completion is 2019-09-01.
What interventions are being tested in trial NCT03380091?
The interventions under investigation include: Metformin (DRUG), Vitamin D (DRUG).
Who is sponsoring clinical trial NCT03380091?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03380091's enrollment target sits among peer trials
5 1989th of 2000 higher than 7 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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