A Study to Evaluate the PK and PD of IM or SQ Injections of Levonorgestrel Butanoate (LB) for Female Contraception

Inclusion Criteria:

1. Good general health with no chronic medical conditions that result in periodicexacerbations that require significant medical care.

2. Age between 18 and 40 years inclusive at the injection visit.

3. BMI < 40 kg/m2.

4. Intact uterus with at least one ovary.

5. Pap test within ASCCP or ACOG guidelines such that additional treatment will not berequired during the study period. If a copy of a Pap test (and indicated follow-uptesting) is not available and the subject is 21 years or older, a Pap test should bedone during the screening period.

6. Regular menstrual cycles that occur every 21-35 days:

6a. If subject is postpartum or post-second trimester abortion, she must have 3 menses (2 cycles) prior to enrollment.

6b. If subject had a first trimester abortion or pregnancy loss, she must have one spontaneous menses prior to enrollment.

7. Have a negative urine pregnancy test at the injection visit and no unprotected heterosexual intercourse for the previous 10 days.

8. Not at risk for pregnancy for the duration of study participation (screening through last phone contact), defined as one of the following: 8a. heterosexually abstinent; 8b. previous female permanent contraception procedure; 8c. in a monogamous relationship with a vasectomized partner; 8d. consistent use of a non-hormonal barrier method with every act of intercourse (e.g. condoms or diaphragm + spermicide).

8e. use copper IUD 9. Subjects must be ovulatory as confirmed by a documented screening progesterone (P4) level ≥ 3 ng/ml by local laboratory.

10. In the opinion of the investigator, subject is willing and able to comply with the protocol requirements.

11. Willing to record requested information in the daily diary. 12. Lives within the study site catchment area or within a reasonable distance from the site.

12. Understands and signs an Institutional Review Board (IRB) approved informed consent form prior to undergoing any screening assessments (including fasting blood draw).

13. Agrees not to participate in any other clinical trials during the course of this study.

Exclusion Criteria:

1. Known hypersensitivity or contraindication to progestins.

2. Abnormal Transvaginal Ultrasound (TVUS) or safety labs done during the screeningperiod recognized as clinically significant by the investigator (or medicallyqualified designee).

3. Greater than 10% body weight change over previous year or planned significant weightloss during the study related to bariatric surgery, dieting or other causes.

4. Known or suspected current alcohol dependence syndrome, chronic marijuana use or anyillicit drug use that may affect metabolism of the study product or studycompliance.

5. Undiagnosed abnormal genital bleeding.

6. Undiagnosed vaginal discharge, lesions or abnormalities. Subjects diagnosed atscreening with Chlamydia, or gonococcus infection may be included in the trialfollowing treatment completion. In accordance with PI/medical designee assessmentand local standards of practice, women with a history of genital herpes can beincluded if outbreaks are infrequent. Antiviral prophylactic therapy is permitted.

7. Uncontrolled thyroid disorder.

8. Current use of hormonal contraception including hormonal intrauterine device.

9. Use of a long-acting injectable hormonal contraceptive (e.g., cyclofem ordepomedroxyprogesterone acetate) within the past 9 months prior to enrollment unlessthe subject has had at least one spontaneous menstrual cycle (at least two menses)since the last injection.

10. Recent use of hormonal oral, patch, intravaginal or intrauterine contraceptionunless that subject has had at least one complete menstrual cycle (at least twomenses) since discontinuation before the treatment injection.

11. Women who are breastfeeding or are within 30 days of discontinuing breastfeedingunless the subject has already had a menses following discontinuation ofbreastfeeding.

12. Women planning to undergo major surgery during study participation.

13. Women planning pregnancy during their anticipated months of study participation.

14. Women who smoke > 15 cigarettes per day or who use >1 ml/day of nicotine-containingliquid for electronic cigarette must be evaluated by the PI for inclusion based onrisk factors that would increase their risk for cardiovascular disease (CVD) andthromboembolism.

15. Current or past deep vein thrombophlebitis or thromboembolic disorders.

16. Known history of thrombophilia.

17. Cerebrovascular or cardiovascular disease or increased risk for arterial thrombosis.

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

19. Current or past medically diagnosed severe depression, which, in the opinion of theinvestigator, could be exacerbated by use of a hormonal contraceptive, unless she isstable on antidepressant medication.

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

21. History of any other carcinoma (excluding basal cell carcinomas) unless in remissionfor more than 5 years.

22. Active liver disease or screening LFTs greater than twice the upper limit or normal.

23. Diastolic blood pressure (DBP) > 95 and Systolic blood pressure (SBP) > 145 mm Hg.

24. Clinically significant abnormal serum chemistry or hematology values according tothe Principal Investigator's judgment.

25. Participation in another clinical trial involving an investigational drug or devicewithin last the three months before treatment injection or planning to participatein another clinical trial during this study.

26. A Z-Score of ≤ -2.0 on baseline Dual-energy X-ray absorptiometry (DXA) scan (within 90 days prior to the injection visit).

27. Known HIV infection.

28. Women who use any medications on the Exclusionary Medication List (see Appendix 2)OR have used any within 90 days prior to the Injection visit.

29. Have issues or concerns (in the judgement of the investigator) that may compromisethe safety of the subject or confound the reliability of compliance and informationacquired in this study.

30. Have known hypersensitivity to the active substance LB or any of the excipients ofthe study treatment.

31. Use any medications that can interfere with the metabolism of hormonalcontraceptives, antibiotics that can interfere with metabolism of hormonalcontraceptives, or any drugs designated by the FDA as falling in the Pregnancy andLactation narrative subsections (formerly Category D or X medications).

32. Have previously participated in the study. A waiver may be requested to allowsubjects to re-enroll, but only in a separate stage from the prior enrollment(s).Subjects must have had clear documentation of ovulation based on a rise inprogesterone in their previous enrollment.

33. Be a site staff member with delegated study responsibilities or a family member of,or have a close relationship with, a site staff member with delegated studyresponsibilities.