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Cilostazol and Its Effects on Resumption of Meiosis in the Human Ovary

NCT01915069 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2015-05-12

No results posted yet for this 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.

Conditions

  • Contraception

Interventions

DRUG

Cilostazol

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
33 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01915069 on ClinicalTrials.gov