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NCT03819140 · ClinicalTrials.gov registry record · Phase 4
Continuous Versus Cyclical OCP Use in PCOS
A Phase 4 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 4
- Development phase
- 51
- Enrollment target
NCT03819140 is a Phase 4 study that has completed, run by University of California, San Francisco. The registered enrollment target is 51 participants.
The verdict
NCT03819140, a Phase 4 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 51 participants
- Enrollment target
Study Summary
The mainstay treatment for females with Polycystic Ovary Syndrome (PCOS) has long been a combination of an oral contraceptive pill or OCP (containing both estrogen and progestin) along with an anti-androgen medication (such as Spironolactone) to not only prevent chronic anovulation but also suppress elevated testosterone levels and its clinical effects on the body. While there are multiple OCPs available on the market today and several studies that look at different progestins and their anti-androgenicity, not much is known about whether the length of active pills in OCP therapy (3 weeks versus 6 months) has any further benefit in continued suppression of testosterone and subsequently improvement in clinical findings of hyperandrogenism in the PCOS population. In this pilot randomized open label clinical trial, females between the ages of 16 and 35 years diagnosed with PCOS based on the Rotterdam Criteria, and not currently on medical therapy with an OCP will be enrolled in the study and randomized to either a continuous 6 month OCP or cyclical 21 day active OCP therapy. Our aim is to conduct a pilot randomized clinical trial to determine the effect of 6 months of active monophasic OCPs on testosterone levels and cutaneous findings of hyperandrogenism (hirsutism and acne) as compared to a traditional 21 day active/7 day placebo OCP in women with PCOS. These findings will be compared over a 6 month period.
Interventions
- DRUG Yasmin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2022-10-16 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03819140
The ClinicalTrials.gov registry entry for NCT03819140 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Yasmin is the first listed.
NCT03819140 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03819140 about?
NCT03819140 is a clinical study titled "Continuous Versus Cyclical OCP Use in PCOS". The mainstay treatment for females with Polycystic Ovary Syndrome (PCOS) has long been a combination of an oral contraceptive pill or OCP (containing both estrogen and progestin) along with an anti-androgen medication (such as Spironolactone) to not only prevent chronic anovulation but also suppress...
What is the current status of trial NCT03819140?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 51 participants. The study started on 2019-04-01. Estimated completion is 2022-10-16.
What interventions are being tested in trial NCT03819140?
The interventions under investigation include: Yasmin (DRUG).
Who is sponsoring clinical trial NCT03819140?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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