Status:
COMPLETED
Open Label Study of the Safety and Contraceptive Efficacy of BufferGel® With Diaphragm
Lead Sponsor:
ReProtect Inc
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Premier Research
Conditions:
Contraception
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to study the safety and contraceptive effectiveness of BufferGel used with a contraceptive diaphragm.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00397670
Start Date
January 1 2004
End Date
May 1 2006
Last Update
November 9 2006
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