Phase II Study of Ovulation in Obese Women

Inclusion Criteria:

1. Female in good general health with no chronic medical conditions that result inperiodic exacerbations that require significant medical care.

2. Age between 18 to 40 years inclusive at time of enrollment.

3. BMI ≥30 kg/m² and no recent rapid weight loss or gain.

4. Intact uterus with both ovaries intact.

5. Papanicolaou test within American Society for Colposcopy and Cervical Pathology (ASCCP), or American College of Obstetricians and Gynecologists (ACOG) guidelinessuch that additional testing or evaluation will not be required during the studyperiod. If there is no copy of a recent Papanicolaou test and the subject is 21years or older a Papanicolaou test should be done during the screening visit.

6. Regular menstrual cycles with an interval of 24 to 32 days:

7. If postpartum or post-second trimester abortion, she must have 2 spontaneousmenses prior to enrollment.

8. If the subject has had a first trimester pregnancy loss or abortion, she musthave one spontaneous menses prior to enrollment.

9. Have a negative urine pregnancy test on menstrual cycle day 9 pre-treatment visit.

10. Not at risk of pregnancy for the duration of the study defined as heterosexuallyabstinent, prior female or male permanent contraception, non-hormonal intrauterinedevice or willing to use a non-hormonal barrier contraceptive method with each actof intercourse until study exit.

11. Subject is willing and able in the Investigators opinion of complying with protocolrequirements.

12. Subject is willing to collect daily first morning urines and store them untilbrought to the study site.

13. Lives within the study catchment area or a reasonable distance from the study site.

14. Understands and signs the IRB approved informed consent prior to undergoing anyscreening assessment.

15. Agrees not to participate in any other clinical trials during the course of thisstudy.

16. Screening serum progesterone level greater than 3 ng/ml.-

Exclusion Criteria:

1. Known hypersensitivity or contraindications to progestins.

2. Abnormal transvaginal ultrasound or safety laboratory results evaluated during thescreening period recognized as clinically significant by the investigator ormedically qualified designee.

3. Known or suspected alcohol or marijuana abuse.

4. Undiagnosed abnormal genital bleeding.

5. Undiagnosed vaginal discharge, lesions or abnormalities.

6. Women with a history of genital herpes can be included if the outbreaks areinfrequent. Antiviral prophylaxis is allowed.

7. Uncontrolled Thyroid disorder.

8. Current use of hormonal contraception or a levonorgestrel releasing intrauterinedevice.

9. Use of a long-acting injectable hormonal contraceptive within the past 6 monthsunless has had at least one spontaneous menstrual cycle (two menstrual bleedingepisodes) since the last injection.

10. Breastfeeding women or those who have not had a spontaneous menstrual bleed sincediscontinuing breastfeeding.

11. Women who plan a major surgical procedure during the study.

12. Women who plan to become pregnant during their participation in the study.

13. Women who smoke >15 cigarettes per day or who use >1 mL/day of nicotine-containingliquid for electronic cigarettes.

14. Current or history of ischemic heart disease or stroke while pregnant or during useof hormonal contraception.

15. Current or past deep vein thrombosis or thromboembolic disorder.

16. Personal or family history of thrombophilia

17. History of retinal vascular lesions or partial or complete loss of vision.

18. Known or suspected carcinoma of the breast, endometrium, or other suspectedprogestin sensitive neoplasia.

19. History of other carcinomas excluding basal cell cancers unless in remission for > 5years.

20. Current or past medically diagnosed severe depression unless the potentialparticipant is on stable medication or in the opinion of the Principal Investigatorcould be exacerbated using a hormonal contraceptive.

21. History of headaches with focal neurologic symptoms.

22. Have a current need for exogenous hormones or therapeutic anticoagulants.

23. History of cholestatic jaundice of pregnancy or jaundice with prior steroid hormoneuse.

24. Other benign or malignant liver tumors or active liver disease.

25. Systolic BP ≥145 mm Hg and/or diastolic BP ≥96 mm Hg after 5 -10 minutes of rest ina sitting position. If the initial BP values are above these cut-offs, a total of 3measurements may be taken and the results averaged. If the averaged BP is below thecut-off levels, the participant may be allowed into the study. Hypertension that istreated and controlled may be allowed based on the Investigator's discretion.

26. Clinically significant abnormal serum chemistry value based on the Investigator'sjudgement.

27. Participation in another clinical trial involving an investigational drug or devicewithin the past two months before anticipated enrollment or is planning toparticipate in another clinical study during this study.

28. Use of any liver enzyme inducers or plans to use such medication during the study.

29. Known HIV infection.

30. History of a gastrointestinal ulcer or bleeding.

31. Women who are using medication on the Exclusionary medication list (See Appendix).

32. Have issues or concerns, in the opinion of the Investigator, that may compromise thestudy or confound the reliability of compliance and information that is required inthis study.

33. Have a known hypersensitivity to either levonorgestrel or a non-steroidalanti-inflammatory drug.

34. Use of any medication that could interfere with the metabolism of a hormonalcontraceptive or the non-steroidal anti-inflammatory drugs or any drug that falls inFDA Pregnancy and Lactation narrative subsections (Formerly Category D or Xmedications).

35. Be a site member with delegated study responsibilities or a family member of, orhave a close relationship with, a site staff member who will be delegated studyresponsibilities.