Oral Levonorgestrel Plus Meloxicam, IG-002 Delays Ovulation in Normal Menstruating Women by Seven Days

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 norecent rapid weight loss or gain. 4. Intact uterus with both ovaries intact. 5. PAPtest within ASCCP or ACOG guidelines such that additional testing or evaluation willnot be required during the study period. If there is no copy of a recent PAP test andthe subject is 21 years or older a Pap test should be done during the screening visit.
3. Regular menstrual cycles with an interval of 24 to 32 days:
4. If postpartum of post-second trimester abortion, she must have 5 menses prior toenrollment.
5. If the subject has had a first trimester pregnancy loss or abortion, she musthave one spontaneous menses prior to enrollment.
6. Have a negative urine pregnancy test on menstrual cycle day 9 pre-treatmentvisit.
7. Not at risk of pregnancy for the duration of the study defined asheterosexually abstinent, prior female or male permanent contraception,non-hormonal intrauterine device or willing to use a non-hormonal barriercontraceptive method with each act of intercourse until study exit.
8. Subject is willing and able in the Investigators opinion of complying withprotocol requirement's 10. Subject is willing to collect daily urine firstmorning urine and store them until collected.
9. Lives within the study catchment area or a reasonable distance from the studysite.
10. Understands and signs the IRB approved informed consents prior to undergoingany screening assessment.
11. Agrees not to participate in any other clinical trials during the course ofthis study.
12. 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 evaluatedduring the screening period recognized as clinically significant aby theinvestigator or medically qualified designee.
3. Known or suspected alcohol or marijuana abuse.
4. Undiagnosed abnormal genital bleeding.
5. Undiagnosed vaginal discharge, lesions or abnormalities. Women with ahistory of genital herpes can be included if the outbreaks are infrequent.Antiviral prophylaxis is allowed.
6. Uncontrolled Thyroid disorder.
7. Current use of hormonal contraception or a levonorgestrel releasingintrauterine device.
8. Use of a long-acting injectable hormonal contraceptive within the past 6months unless has had at least one spontaneous menstrual cycle (twomenstrual bleeding episodes) since the last injection.
9. Breastfeeding women or those who have not had a spontaneous menstrual bleedsince discontinuing breastfeeding.
10. Women who plan a major surgical procedure during the study.
11. Women who plan to become pregnant during their participation in the study.
12. Women who smoke >15 cigarettes per day or who use >1 mL/day ofnicotine-containing liquid for electronic cigarettes.
13. Current or history of ischemic heart disease or stroke while pregnant orduring use of hormonal contraception.
14. Current or past deep vein thrombosis or thromboembolic disorder.
15. Personal or family history of thrombophilia
16. History of retinal vascular lesions or partial or complete loss of vision.
17. Known or suspected carcinoma of the breast, endometrium, or other suspectedprogestin sensitive neoplasia.
18. History of other carcinomas excluding basal cell cancers unless in remissionfor > 5 years.
19. Current or past medically diagnosed severe depression unless the potentialparticipant is on stable medication or in the opinion of the PrincipalInvestigator could be exacerbated by the use of a hormonal contraceptive.
20. History of headaches with focal neurologic symptoms.
21. Have a current need for exogenous hormones or therapeutic anticoagulants .
22. History of cholestatic jaundice of pregnancy or jaundice with prior steroidhormone use.
23. Other benign or malignant liver tumors or active liver disease.
24. Systolic BP ≥145 mm Hg and/or diastolic BP ≥96 mm Hg after 5 -10 minutes ofrest in a sitting position. If the initial BP values are above thesecut-offs, a total of 3 measurements may be taken and the results averaged.If the averaged BP is below the cut-off levels, the participant may beallowed into the study. Hypertension that is treated and controlled may beallowed based on Investigator's discretion.
25. Clinically significant abnormal serum chemistry value based on theInvestigator's judgement.
26. Participation in another clinical trial involving an investigational drug ordevice within the past two months before anticipated enrollment or isplanning to participate in another clinical study during this study.
27. Use of any liver enzyme inducers or plans to use such medication during thestudy.
28. Known HIV infection.
29. History of gastrointestinal ulcers or bleeding.
30. Women who are using medication on the Exclusionary medication list (SeeAppendix).
31. Have issues or concerns in the opinion of the Investigator that maycompromise the sturdy or confound the reliability of compliance andinformation that is required in this study.
32. Have a known hypersensitivity to either levonorgestrel or a non-steroidalanti-inflammatory drug.
33. Use of any medication that could interfere with the metabolism of a hormonalcontraceptive or the non-steroidal anti-inflammatory drugs or any drug thatfalls in FDA Pregnancy and Lactation narrative subsections (FormerlyCategory D or X medications).
34. Be a site member with delegated study responsibilities or a family memberof, or have a close relationship with, a site staff member who will bedelegated study responsibilities.