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

NCT01915069 | Completed Phase 2 DMC

• 1 other identifier: SFPRF 13-14
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

contraception; Cilostazol; phosphodiesterase inhibitors; To assess the ability of Cilostazol to act as a contraceptive agent

Outcome Measures

Primary Outcomes (1)

• Oocyte maturation

  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 study drug.

  6 weeks

Other Outcomes (1)

• Serum and follicular fluid cilostazol levels

  6 weeks

Study Arms (1)

Cilostazol

EXPERIMENTAL

The primary aim of the study is to assess the affects of oral Cilostazol taken at the FDA approved dose of 100mg PO bid on human oocyte maturation.

Drug: Cilostazol

Interventions

Cilostazol DRUG

Also known as: Pletal

Cilostazol

Eligibility Criteria

• Age: 18 Years - 33 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• previous oocyte donor in USC IVF clinic within past 3 years
• age 18-33
• willingness and ability to commit to the time requirements of the study
• willingness to donate oocytes for research purposes
• willingness to discontinue current hormonal contraception
• otherwise healthy subjects

You may not qualify if:

• contraindications to combined hormonal contraceptive use (CDC MEC class 3 or 4)
• pregnancy
• history of cardiac arrhythmias
• history of heart failure
• history of bleeding disorder
• concomitant use of anti-platelet therapy such as aspirin
• current use of drugs that inhibit cytochrome P450 CYP 3A4 (erythromycin, diltiazem, ketoconazole, itraconazole) or CYP 2C19 (omeprazole) as they may lead to increased serum levels of cilostazol.

Sponsors & Collaborators

• University of Southern California: lead
• Society of Family Planning: collaborator

Study Sites (1)

University of Southern California Fertility Clinic

Los Angeles, California, 90017, United States

Location

MeSH Terms

Interventions

Cilostazol

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Family Planning Research Fellow, Department OBGYN

Study Record Dates

• First Submitted: July 5, 2013
• First Posted: August 2, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

US (1)