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NCT01915069 · ClinicalTrials.gov registry record · Phase 2
Cilostazol and Its Effects on Resumption of Meiosis in the Human Ovary
A Phase 2 study, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT01915069: Completed Phase 2 study, sponsored by University of Southern California.
NCT01915069 is a Phase 2 study that has completed, run by University of Southern California. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01915069, a Phase 2 study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
Combined oral contraceptive pills (COCs) are the most commonly used hormonal form of birth control in the United States with at least 87% of women of reproductive age reporting oral contraceptive use at some point in their lives (9). Despite their frequent use, the six and twelve month discontinuation rates for oral contraceptive pills are 31 and 47 % respectively (17), with common reasons for discontinuation attributed to the side effects of abnormal bleeding, headache, and weight gain. Additionally, COCs are contraindicated in certain groups of women as outlined by The Centers for Disease Control Medical Eligibility Criteria (11). Given the high prevalence of oral contraceptive users who commonly discontinue use secondary to side effects or who are not eligible for use as a result of underlying health conditions, the development of novel oral non-hormonal methods that are equally effective at pregnancy prevention are warranted. This current study aims to evaluate the effect of an FDA approved drug, Cilostazol, on human oocyte maturation. Such a study has not been conducted to date. If Cilostazol demonstrates an ability in humans to affect resumption of meiosis, then this non-hormonal agent could be uses as a possible contraceptive agent in the future. This knowledge would have profound reproductive health implications. The investigators propose that women undergoing treatment with the FDA approved dose of 100mg PO every 12 hours of Cilostazol will demonstrate an impairment of egg maturation in comparison to paired historic controls following ovarian follicle stimulation.
Primary Outcome
For the purposes of our study, oocyte maturation will be assessed using the oocyte maturational stages of prophase I, metaphase I, and metaphase II. Thus, we will be assessing the percent of oocytes aspirated from follicles during controlled ovarian stimulation that progress beyond the germinal vesicle stage (e.g. GVBD) in those women receiving cilostazol and compare this to the maturation of oocytes obtained from the same women who underwent ovarian follicle stimulation previously while not on
Interventions
- DRUG Cilostazol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-08 |
| Phase | Phase 2 |
What the finished NCT01915069 record still lists
NCT01915069 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Cilostazol is the first listed.
NCT01915069 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01915069 about?
NCT01915069 is a clinical study titled "Cilostazol and Its Effects on Resumption of Meiosis in the Human Ovary". Combined oral contraceptive pills (COCs) are the most commonly used hormonal form of birth control in the United States with at least 87% of women of reproductive age reporting oral contraceptive use at some point in their lives (9). Despite their frequent use, the six and twelve month discontinuati...
What is the current status of trial NCT01915069?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2013-07. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01915069?
The interventions under investigation include: Cilostazol (DRUG).
Who is sponsoring clinical trial NCT01915069?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01915069's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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