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

WHAT IS THE FEMALE CONDOM? The female condom being examined in this study is investigational (experimental) and is not yet approved by the Food and Drug Administration (FDA). The female condom is made up of a pouch that adjusts to the shape of the vagina. The female condom that will be used in this study is not lubricated, but a water-based lubricant will be provided for you to use with it. Also, the female condoms used in this study will be provided to you at no cost.

WHY IS THIS STUDY BEING DONE?

The purpose of this study is to find out:

* How well the female condom works to prevent pregnancy
* How well the female condom works to prevent transmission of sexually transmitted diseases
* How safe the female condom is to use
* If urinary tract infections and symptomatic vaginal infections occur while using the female condom
* How well women like the female condom
* How well the female condom performs.

WHAT DOES THE STUDY INVOLVE? There will be approximately 10 clinics in the study with about 500 women from all over the United States participating in this study. You are being asked to participate in a research study because you are a woman between the ages of 18 and 40, are in general good health, have regular menstrual cycles, do not want to become pregnant for at least the next 7 months, and are willing to rely on the female condom as your primary method of contraception during study participation.

HOW LONG DOES THE STUDY LAST? Enrollment for this study is expected to last about 12 months. You will need to come to the clinic for a screening/admission visit and then 2 or more visits. You will also be asked to complete a diary every day about your use of the female condoms. The clinical staff will help set up your planned clinical visits during the study.

This is a Phase III multicenter, open-label, non-comparative trial of the Woman's Condom to evaluate contraceptive efficacy as the primary method of contraception. Secondary evaluations include safety assessment, incidence of UTIs, symptomatic vaginal infection, performance of the Woman's Condom (clinical breakage, slippage, misdirection, and invagination) and overall acceptability of the product. We will perform a Substudy to assess the semen biomarker as a means of detecting product failure in a subset of subjects.

Eligibility Criteria:
Inclusion Criteria

To enroll into the clinical trial, potential subjects must:

1. Be healthy women, who are sexually active, at risk for pregnancy and desiring contraception.
2. Be within the age range of 18 through 40 years inclusive at enrollment.
3. Have a negative urine pregnancy test at the admission visit.
4. Have a history of regular cyclic menses with a usual length of 21 to 35 days when not using hormonal contraception.
5. Have one menses after switching from oral contraceptives to using the Woman's Condom.
6. Have at least one spontaneous menstrual cycle (two menses) following a pregnancy that ended at 14 or more weeks gestation.
7. Have at least one cycle (two menses) after an abortion at less than 14 weeks gestation.
8. Be willing to accept a risk of pregnancy.
9. Be willing to engage in at least four acts of heterosexual vaginal intercourse per month for a period of 6 months.
10. Be willing to only use the study product as the primary method of contraception over the course of the study.
11. Be capable of using the study product properly and agree to observe all study directions and requirements.
12. 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.
13. Be willing to state that, to her best knowledge, her sexual partner(s):

    1. Has not had a vasectomy or been previously diagnosed as infertile.
    2. Has not been previously diagnosed or suspected of HIV unless he has subsequently had a negative HIV test.
    3. 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.
    4. Has not shared injection drug needles in the past unless he has had a negative HIV test at least 6 weeks since last use.
    5. Has no known history of allergy or sensitivity to polyurethane (condom pouch), polyvinyl alcohol (capsule), or other water-based lubricants such as Astroglide.
14. Agree not to participate in any other clinical trials during the course of this study.
15. Be willing to give written informed consent to participate in the trial.

Exclusion Criteria

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

1. Have a history of allergy or sensitivity to polyurethane (condom pouch), polyvinyl alcohol (capsule), or other water-based lubricants such as Astroglide.
2. 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.
3. 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.
4. Be pregnant, have a suspected pregnancy or desire to become pregnant during the course of the study.
5. Have a history of infertility or pelvic inflammatory disease without a subsequent spontaneous intrauterine pregnancy.
6. Have been diagnosed with pelvic inflammatory disease (PID) without a subsequent intrauterine pregnancy.
7. Be in a monogamous relationship of less than 4 months with their partner.
8. Have any contraindications to pregnancy (medical condition) or regularly use category D or X or exclusionary medications listed in Appendix F.
9. Have shared injection drug needles in the past unless has a negative HIV test at least 6 weeks since last use.
10. Have known or suspected to have an HIV infection.
11. 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.
12. Be lactating or breastfeeding.
13. Have any clinically significant abnormal vaginal bleeding or spotting within the month prior to screening.
14. Have had vaginal or cervical biopsy or vaginal surgery within 3 months prior to screening.
15. Have used vaginal or systemic antibiotics or antifungal agents within 14 days prior to screening or enrollment.
16. Have received a Depo-Provera® injection in the 9 months prior to enrollment (this exclusionary time period can be shortened to 6 months if the subject has also had 2 spontaneous menstrual cycles \[requires minimum of 3 menses\] that meet criteria for normal menstrual cycles).
17. Have an abnormal Pap test based on the following criteria:

    * Pap test in the past 15 months with ASC-US unless:

      * less than 21 years of age;
      * a repeat Pap test at least 6 months later was normal;
      * reflex HPV testing was performed and was negative for high-risk HPV; or
      * a colposcopy (with or without biopsy) found no evidence of dysplasia requiring treatment or treatment was performed and follow-up at least 6 months after the treatment showed no evidence of disease;
    * Pap test in the past 15 months with LSIL unless:

      * less than 21 years of age;
      * a colposcopy (with or without biopsy) found no evidence of dysplasia requiring treatment or treatment was performed and follow-up at least 6 months after the treatment showed no evidence of disease;
    * Pap test in the past 15 months with ASC-H, atypical glandular cells, or HSIL unless colposcopy and/or treatment was performed and follow-up at least 6 months after the colposcopy and/or treatment showed no evidence of disease;
    * Pap test in the past 15 months with malignant cells.
18. Have a past (within 12 months) or current history of alcohol or drug \[recreational, prescription or over-the-counter (OTC)\] abuse.
19. Have taken an investigational drug or used an investigational device within the past 30 days.
20. Have previously participated in or completed this study.
21. Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study. For example, if the subject is found to have Condyloma Accuminata, the investigator can decide whether to exclude the subject or not, depending on its location and if use of the condom may be painful for the subject.