Clinical trial NCT01166412 (phase 1/phase 2, status: completed)
Conditions: contraception
ICD codes: Z92.0, Z30.012, Z30.09
Drugs: levonorgestrel patch with bmi 32 kg/m2 to <40 kg/m2, levonorgestrel patch with bmi <32 kg/m2, levonorgestrel patch with bmi 32 kg/m2 to <40 kg/m2, levonorgestrel patch with bmi <32 kg/m2
SMILES: [H][C@@]12CC[C@@](O)(C#C)[C@@]1(CC)CC[C@]1([H])[C@@]3([H])CCC(=O)C=C3CC[C@@]21[H], [H][C@@]12CC[C@@](O)(C#C)[C@@]1(CC)CC[C@]1([H])[C@@]3([H])CCC(=O)C=C3CC[C@@]21[H], [H][C@@]12CC[C@@](O)(C#C)[C@@]1(CC)CC[C@]1([H])[C@@]3([H])CCC(=O)C=C3CC[C@@]21[H], [H][C@@]12CC[C@@](O)(C#C)[C@@]1(CC)CC[C@]1([H])[C@@]3([H])CCC(=O)C=C3CC[C@@]21[H]
Eligibility criteria:

        Inclusion Criteria:

          -  1. Good general health.

          -  2. Aged 18-44 years, inclusive, at the enrollment visit.

          -  3. Intact uterus with at least one ovary.

          -  4. Pap test within the last 12 months or undergo a Pap test at screening prior to
             enrollment. If a potential subject states that she has had a Pap test within the last
             12 months, then she will need to provide documentation of acceptable test results.

          -  5. Cervical mucus score of >7, which is based on the modified Insler scoring system
             during the screening cycle. The cervical mucus is collected by aspiration and the
             assessment is based on the modified Insler scoring system (the volume and pH of the
             mucus are not included in the total scoring) yielding a total possible score of 12 (3,
             4).

          -  6. Regular menstrual cycles that occur every 28 ± 7 days.

               1. If subject is postpartum or post-abortal (with abortion in second trimester), she
                  will be required to have two normal menstrual cycles prior to screening.

               2. If subject had an abortion in the first trimester, she will be required to have
                  at least one menstrual cycle (two menses) prior to screening.

          -  7. Heterosexually abstinent or, if heterosexually active, must have undergone previous
             tubal sterilization, be in monogamous relationship with a vasectomized partner, or
             only use male or female condoms (use of condoms that are pre-lubricated with or
             without spermicide is acceptable) for the entire duration of the study. Use of a
             spermicide applied separately is not allowed. Cervical caps or diaphragms are not
             allowed during study participation.

          -  8. In the opinion of the investigator, able to comply with the protocol, willing to
             record requested information in the daily diary, and live within the study site
             catchment area or within a reasonable distance from the site.

          -  9. Understand and sign an IRB approved informed consent form prior to screening
             activities (including fasting blood draw).

          -  10. Willing to refrain from use of skin lotions/creams/gels on area of patch
             application and not use any vaginal creams, lubricants, gels, or spermicides for 3
             days prior to study admission through to the end of the study.

          -  11. Agree not to participate in any other clinical trials during the course of this
             study.

        Exclusion Criteria:

        Contraindications for enrollment will be the same as those for use of combined hormonal
        contraceptives as referenced in the World Health Organization (WHO) Medical Eligibility
        Criteria(MEC category 1 or 2) (1), in addition to contra-indications specific to this
        clinical trial including:

          -  1. Known hypersensitivity or contraindication to progestins.

          -  2. Known or suspected pregnancy.

          -  3. Prior hysterectomy or bilateral oophorectomy.

          -  4. Prior cervical surgery (LEEP, Cone biopsy, Cryosurgery).

          -  5. A history (within prior 12 months) or drug or alcohol abuse.

          -  6. Undiagnosed abnormal genital bleeding.

          -  7. Undiagnosed vaginal discharge or vaginal lesions or abnormalities. Subjects
             diagnosed at screening with a Chlamydia or gonococcus infection may not be included in
             the trial unless they are treated and proof of cure is documented after treatment
             (i.e. repeat test with negative results). In accordance with PI/medical designee
             assessment and local standards of practice, women with a history of genital herpes can
             be included if outbreaks are infrequent. Antiviral prophylactic therapy is permitted.

          -  8. Uncontrolled thyroid disorder.

          -  9. History or presence of dermal hypersensitivity in response to topical application.
             Specifically any reaction to application of a plastic bandage (Band-Aid), surgical or
             bandage tape, other skin patches, or adhesives.

          -  10. Any Pap test finding that would require additional workup or treatment during the
             study interval. HPV testing will not be done at screening for these subjects.

          -  11. Use of an injectable hormonal contraceptive (Depo-Provera®) within the past 10
             months.

          -  12. Use of oral contraceptives, contraceptive implants, or other sex steroid hormones
             within 30 days prior to screening visit.

          -  13. Women who are breastfeeding or within 30 days of discontinuing breast feeding.

          -  14. Women planning to undergo major surgery within four months of study enrollment.

          -  15. Women planning pregnancy within their months of study enrollment.

          -  16. Smoking in women who are ages 18-44 years old that smoke 15 cigarettes or more per
             day must be evaluated by the PI for inclusion based on risk factors that would
             increase their risk for CVD and thromboembolism.

          -  17. Current or past deep vein thrombophlebitis or thromboembolic disorders.

          -  18. History of known thrombophilia in a first-degree relative <45 years of age
             suggesting familial defect in blood coagulation system, which in the opinion of the
             principal investigator, suggests use of a hormonal contraceptive could pose a
             significant risk.

          -  19. Cerebrovascular or cardiovascular disease or increased risk for arterial
             thrombosis.

          -  20. History of retinal vascular lesions, unexplained partial or complete loss of
             vision.

          -  21. Known or suspected carcinoma of the breast, endometrium, or any other known or
             suspected progestin-dependent neoplasia.

          -  22. Past history of any other carcinoma (excluding basal cell carcinomas) unless in
             remission for more than 5 years.

          -  23. Current or past medically diagnosed severe depression, which, in the opinion of
             the investigator, could be exacerbated by use of a hormonal contraceptive, unless she
             is stable on antidepressant medication.

          -  24. Headaches with focal neurological symptoms only in women over 35 years old.

          -  25. History of cholestatic jaundice of pregnancy or jaundice with prior steroid use or
             other benign or malignant liver tumors; active liver disease.

          -  26. Systolic BP > 140 mm Hg and/or Diastolic blood pressure (BP) > 90 mm Hg after 5-10
             minutes rest.

          -  27. Clinically significant abnormal serum chemistry values according to the Principal
             Investigator's judgment.

          -  28. Participation in another clinical trial involving an investigational drug or
             device within last 30 days (prior to screening).

          -  29. Use of liver enzyme inducers within last 90 days (prior to screening) or intention
             to use liver enzyme inducers during the study (see Appendix 2 Exclusionary Medication
             List).

          -  30. Known HIV infection.

          -  31. Women at high risk of contracting HIV, e.g. women with multiple sex partners who
             need to use condoms consistently, injection drug users. Women enrolled in the study,
             who use condoms to protect against STIs or pregnancy, should be instructed that they
             can use condoms that are pre-lubricated with spermicide or lubricated, but they cannot
             use a spermicide applied separately and they should record all condom use in their
             diaries.

          -  32. Women who use any medications on the Exclusionary Medication List (see Appendix 2)
             OR used any within the past three months prior to the screening visit.

          -  33. Women with BMI ≥40 kg/m2 are excluded.