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

NCT00397670 | Completed Phase 2

• 1 other identifier: CCN 003OL
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• Contraceptive efficacy (pregnancy rate) at six months (183 days).

Interventions

Drug: BufferGel® with diaphragm DRUG

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• ReProtect Inc: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Premier Research: collaborator

MeSH Terms

Interventions

BufferGel; Contraceptive Devices, Female

Intervention Hierarchy (Ancestors)

Contraceptive Devices; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 8, 2006
• First Posted: November 9, 2006
• Study Start: January 1, 2004
• Study Completion: May 1, 2006
• Last Updated: November 9, 2006

Record last verified: 2006-11