A Multicenter, Open-Label, Non-Comparative Study of the Safety and Contraceptive Efficacy of the Woman's Condom

Inclusion Criteria

To enroll into the clinical trial, potential subjects must:

• 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 at enrollment.
• Have a negative urine pregnancy test at the admission visit.
• Have a history of regular cyclic menses with a usual length of 21 to 35 days when not using hormonal contraception.
• Have one menses after switching from oral contraceptives to using the Woman's Condom.
• Have at least one spontaneous menstrual cycle (two menses) following a pregnancy that ended at 14 or more weeks gestation.
• Have at least one cycle (two menses) after an abortion at less than 14 weeks gestation.
• Be willing to accept a risk of pregnancy.
• Be willing to engage in at least four acts of heterosexual vaginal intercourse per month for a period of 6 months.
• Be willing to only use the study product as the primary method of contraception over the course of the study.
• Be capable of using the study product properly and agree to observe all study directions and requirements.
• Be willing to keep a diary to record coital information, product use information, information about the use of other vaginal products, and any symptoms, which occurred in her or her partner over the course of study participation.
• Be willing to state that, to her best knowledge, her sexual partner(s):
• Has not had a vasectomy or been previously diagnosed as infertile.
• Has not been previously diagnosed or suspected of HIV unless he has subsequently had a negative HIV test.
• Has not been known to have engaged in homosexual intercourse in the past 5 years unless he has had negative HIV test results since then.
• Has not shared injection drug needles in the past unless he has had a negative HIV test at least 6 weeks since last use.
• Has no known history of allergy or sensitivity to polyurethane (condom pouch), polyvinyl alcohol (capsule), or other water-based lubricants such as Astroglide.
• Agree not to participate in any other clinical trials during the course of this study.
• Be willing to give written informed consent to participate in the trial.

Exclusion Criteria

To enroll into the clinical trial, potential subjects must not:

• Have a history of allergy or sensitivity to polyurethane (condom pouch), polyvinyl alcohol (capsule), or other water-based lubricants such as Astroglide.
• Have current UTI or symptomatic vaginal infection as confirmed by dipstick urinalysis, or if needed by a urine culture or wet mount (see Schedule of Assessments for definitions), unless treated and proof of cure is documented by a negative test result performed at least 2 weeks post-treatment.
• Have evidence of Chlamydia trachomatis or Neisseria gonorrhea infection unless she and her partner(s) complete treatment and proof of cure is documented for the subject only by a negative test result performed at least 3 weeks post-treatment.
• Be pregnant, have a suspected pregnancy or desire to become pregnant during the course of the study.
• Have a history of infertility or pelvic inflammatory disease without a subsequent spontaneous intrauterine pregnancy.
• Have been diagnosed with pelvic inflammatory disease (PID) without a subsequent intrauterine pregnancy.
• Be in a monogamous relationship of less than 4 months with their partner.
• Have any contraindications to pregnancy (medical condition) or regularly use category D or X or exclusionary medications listed in Appendix F.
• Have shared injection drug needles in the past unless has a negative HIV test at least 6 weeks since last use.
• Have known or suspected to have an HIV infection.
• Have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence (initial episode) within 3 months prior to screening or have clinical evidence of HSV on exam.
• Be lactating or breastfeeding.
• Have any clinically significant abnormal vaginal bl