Open Label Study of the Safety and Contraceptive Efficacy of BufferGel® With Diaphragm

ReProtect Inc

Status and phase

Completed

Phase 3

Phase 2

Conditions

Contraception

Treatments

Drug: Drug: BufferGel® with diaphragm

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT00397670

CCN 003OL

Details and patient eligibility

About

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

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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
be willing to only use the test product with diaphragm as the primary method of contraception over the course of the study [with the exception of emergency contraception pills (ECPs), when indicated]
be capable of using the product and diaphragm properly and agree to observe all study directions and requirements

Exclusion criteria

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
have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence (initial episode) within the 3 months prior to screening, or have clinical evidence of HSV on exam
have been diagnosed with any other STDs (including trichomonas) in the 6 months prior to the screening visit
be lactating or breastfeeding have had a Depo-Provera injection in the 10 months prior to screening
have a vaginal or cervical abnormality that would interfere with the proper placement and retention of test product and diaphragm

In addition, in order to be eligible to participate in the trial, potential subjects must state that, to her best knowledge, her sexual partner meets the following criteria:

is not infertile
has not been treated for Chlamydia trachomatis or N. gonorrhoeae in the past 6 months
has not been previously diagnosed with, or suspected to have, HIV infection
has not had more than one sexual partner in the past 4 months
has not engaged in homosexual intercourse in the past 10 years
has not shared injection drug needles in the past 10 years
has no history of allergy or sensitivity to spermicides or products containing N-9
has no history of allergy or sensitivity to products containing latex