Pregnancy Clinical Trial
Official title:
A Randomized, Controlled Trial of the Efficacy, Safety, and Acceptability of BufferGel
Verified date | August 2016 |
Source | Health Decisions |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
BufferGel is a new contraceptive gel designed to be used with a diaphragm. In addition to preventing pregnancy, BufferGel may also prevent some types of sexually transmitted diseases (STDs). This study will compare BufferGel to Gynol II, a currently available contraceptive gel.
Status | Completed |
Enrollment | 975 |
Est. completion date | April 2005 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria - General good health - Sexually active, at risk for pregnancy, and desiring contraception - Low-risk for HIV or STD infection - Single sexual partner who is at low-risk for HIV or STD infection for 6 months prior to study entry - Expect to have same sexual partner for duration of the study - Normal cyclic menses with a usual length of 21 to 35 days - Documented history of at least two spontaneous, normal menstrual cycles since delivery, abortion, or after discontinuing hormonal contraception/hormonal therapy - Willing to accept a risk of pregnancy - Willing to engage in an average of 1 to 2 acts of heterosexual vaginal intercourse per week for a period of 6 months - 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 - Willing to only use the test product with diaphragm as the sole method of contraception over the course of the study (with the exception of emergency contraceptive pills when indicated) - Capable of using the product and diaphragm properly - Willing to keep a diary to record coital information, product use information, information about the use of other vaginal products, and sign and symptom data for self and partner - Agree not to participate in any other clinical trials during the course of the study - Written informed consent to participate in the trial Participant's Sexual Partner Must Not Be/Have - Infertile - Treated for Chlamydia trachomatis or Neisseria gonorrhoeae in the 6 months prior to study entry - HIV infected - More than one sexual partner in the 4 months prior to study entry - Engaged in homosexual intercourse - Shared injection drug needles in the 6 months prior to study entry - Allergy or sensitivity to spermicides or products containing Nonoxynol 9 or latex Exclusion Criteria - Pregnant or desire to become pregnant during the course of the study - History of infertility or conditions that may lead to infertility - Allergy or sensitivity to spermicides or products containing Nonoxynol 9 or latex - History of toxic shock syndrome (TSS) - Two or more urinary tract infections (UTIs) in the 12 months prior to study entry - Current suspected or diagnosed urinary tract infection or vaginitis - Contraindications to pregnancy (medical condition or chronic use of medications contraindicated for pregnancy) - Treated with antibiotics for pelvic inflammatory disease (PID) without a subsequent intrauterine pregnancy - More than one sexual partner in the 4 months prior to study entry - Shared injection drug needles in the 6 months prior to study entry - HIV infected or suspected HIV infection - Genital herpes simplex virus (HSV) infection with the first occurrence (initial episode) within 3 months prior to study entry or have clinical evidence of HSV on exam - Sexually transmitted diseases (STDs) in the 3 months prior to study entry - Lactating or breastfeeding - Abnormal vaginal bleeding or spotting in the month prior to study entry - Lower abdominal or pelvic pain in the month prior to study entry - Abnormal finding on pelvic examination which, in the view of the study investigator, precludes participation in study - Vaginal or cervical irritation, including vaginal or cervical epithelial disruption, ulceration, bleeding, petechiae, sloughing, or areas of obvious erythema - Vaginal or cervical biopsy or surgery in the 3 months prior to study entry - Vaginal or systemic antibiotics, antivirals, or antifungals in the 14 days prior to study entry - Depo-Provera injection in the 10 months prior to study - Vaginal or cervical abnormality that would interfere with the proper placement and retention of test product and diaphragm - Abnormal Pap smear in the 12 months prior to study entry - Consume (on average) greater than 2 to 3 alcoholic beverages per day - Drug abuse (recreational, prescription, or OTC) in the 12 months prior to study entry - Investigational drug or device use in the month prior to study entry - Previously participated in or completed this study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | California Family Health Council | Berkeley | California |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | University of Colorado | Denver | Colorado |
United States | California Family Health Council | Los Angeles | California |
United States | Columbia University | New York | New York |
United States | New York University | New York | New York |
United States | Eastern Virginia Medical School | Norfolk | Virginia |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Health Decisions | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
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