Effectiveness of BufferGel as a Vaginal Contraceptive

- 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

- 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