A Multicenter Open-Label Study of the Safety and Contraceptive Efficacy of BufferGel® Spermicide Used With Diaphragm

ReProtect Inc0 sites200 target enrollmentJanuary 2004

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Contraception
Sponsor: ReProtect Inc
Enrollment: 200
Primary Endpoint: Contraceptive efficacy (pregnancy rate) at six months (183 days).
Status: Completed
Last Updated: 19 years ago

The purpose of this study is to study the safety and contraceptive effectiveness of BufferGel used with a contraceptive diaphragm.

Registry

clinicaltrials.gov

Start Date

January 2004

End Date

May 2006

Last Updated

19 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Sponsor

•be healthy women, who are sexually active, at risk for pregnancy and desiring contraception
•be within the age range of 18 through 40 years inclusive
•be at low-risk for human immunodeficiency virus (HIV) or sexually transmitted disease (STD) infection, currently have (≥4 months) a single sexual partner who is also at low-risk for HIV or STD infection and expect to have the same partner for the duration of the study
•have a negative urine pregnancy test at the admission visit
•have normal cyclic menses with a usual length of 24 to 35 days over the last 2 months
•have a documented history of at least one spontaneous, normal menstrual cycle (two menses) since delivery, abortion, or after discontinuing hormonal contraception/hormonal therapy
•be willing to accept a risk of pregnancy
•be willing to engage in at least 4 acts of heterosexual vaginal intercourse per cycle for a period of approximately seven months
•be willing to be randomized to either study treatment as applicable
•be willing to be fitted with a diaphragm and use the diaphragm with test product during all acts of heterosexual vaginal intercourse for the duration of the study

•have a history of allergy or sensitivity to spermicides, products containing N-9, and/or products containing latex
•have a history of toxic shock syndrome
•have had two or more UTIs in the past year or currently have a suspected or diagnosed UTI or vaginitis by dipstick urinalysis or wet mount, unless treated and proof of cure is documented
•be pregnant, have a suspected pregnancy or desire to become pregnant during the course of the study
•have a history of infertility or conditions which may lead to infertility
•have contraindications to pregnancy (medical condition) or chronic use of class D or X medications
•have been hospitalized for pelvic inflammatory disease without a subsequent intrauterine pregnancy
•have had more than one sexual partner in the past 4 months
•have shared injection drug needles within the past 6 months
•have, or suspected to have, HIV infection