Study of the Safety, Efficacy and Cycle Control of a Contraceptive Vaginal Ring

Inclusion Criteria

• Healthy women, aged 18- 1.0 year in woman or her male partner.
• History of vasectomy or sterility in male partner; tubal ligation (sterilization) in women
• Undiagnosed abnormal genital bleeding.
• Undiagnosed vaginal discharge or vaginal lesions or abnormalities. (Subjects diagnosed at screening with Chlamydia or gonorrhea may be included in the trial following treatment; partner treatment is also recommended. Investigators should make a determination if subjects are at high risk for reinfection, e.g. multiple sex partners, untreated partner, and whether such subjects can be included.)
• History of pelvic inflammatory disease since last pregnancy episode.
• History of toxic shock syndrome.
• Current abnormal Pap smear (women who have abnormal Paps but are ASCUS HPV negative may participate provided there is follow up for this finding per standard of care).
• Cystoceles or rectoceles or other anatomical abnormality that would preclude use of a vaginal ring.
• Women planning to undergo major surgery.
• Smoking in women who are 35 years and over or will be 35 years during the course of the trial; Women 95 kg or >209 lbs.
• Use of liver enzyme inducers on a regular basis.
• Use of monthly injectable contraceptives (e.g. cyclofem) unless suspended 2 months before initiation of treatment. Use of Depo-Proveraâ [depo-medroxyprogesterone (DMPA)] unless suspended 6 months before treatment.
• Current use of implanted hormonal contraceptives, including Mirenaâ [progestin containing intrauterine system (IUS)], Jadelleâ, Norplantâ or Implanonâ (subjects using any of these methods who request removal for reasons unrelated to the purpose of enrollment in this study may be considered for participation).
• Current use of a non-hormonal IUD. Subjects with IUDs who request removal for reasons unrelated to the purpose of enrollment in this study may be considered for participation.
• Known HIV infection.
• Women at high risk of contracting HIV, e.g. women with multiple sex partners who need to use condoms consistently, injection drug users. If women enrolled in the study do use condoms to protect against STIs, they should be instructed that this occasional use should be with non-N-9 containing condoms and they should record condom use in their diaries. Women found to have an STI at screening will be treated prior to inclusion in the study (with the exception of those infected with HIV).