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

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.

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.