Effectiveness of BufferGel as a Vaginal Contraceptive
Completed · Phase 2/Phase 3
Conditions studied: Pregnancy
In brief
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.
Key facts
- Study ID
- NCT00065858
- Run by
- Premier Research
- People needed
- 975
- Starts
- 2001-09-01
- Expected to finish
- 2005-04-01
- Last updated by the study team
- 2016-08-19
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- California Family Health Council — Berkeley, California, United States
- California Family Health Council — Los Angeles, California, United States
- University of Colorado — Denver, Colorado, United States
- New York University — New York, New York, United States
- Columbia University — New York, New York, United States
- University of Cincinnati — Cincinnati, Ohio, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
- Eastern Virginia Medical School — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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