Birth Control Hormonal Injection/Shot Study
This study is studying levonorgestrel butanoate (LB) as a possible long-acting and reversible injectable formulation for female contraception.
-36 visits over 9 months -Physical Exam, Pelvic Exam-On screening Visit and Exit visit only -Trans-Vaginal Ultrasound, Blood draws-On every visit -Bleeding Diaries-will be filled collected weekly after Visit 3
18 to 40 years
? Age: 18-40 ? Regular periods ? Not on hormonal Birth Control
1. Be in good general overall health with no chronic medical conditions that result in periodic exacerbations that require significant medical care. 2. Between 18 and 40 years inclusive at the enrollment 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 be required during the study period. If a copy of a Pap test (and indicated follow-up testing) is not available and the subject is 21 years or older, a Pap test should be done during the screening period. 6. Regular menstrual cycles that occur every 21-35 days: a. If subject is postpartum or post-second trimester abortion, she must have 3 menses (2 cycles) prior to enrollment. b. 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: a. heterosexually abstinent; b. previous female permanent contraception procedure; c. in a monogamous relationship with a vasectomized partner; d. consistent use of a non-hormonal barrier method with every act of intercourse (e.g. condoms or diaphragm + spermicide). e. use copper IUD 9. In the opinion of the investigator, subject is willing and able to comply with the protocol requirements. 10. Subject is willing to record requested information in the daily diary. 11. Lives within the study site catchment area or within a reasonable distance from the site. 12. Understand and sign an IRB approved informed consent form prior to undergoing any screening assessments (including fasting blood draw). 13. Agree not to participate in any other clinical trials during the course of this study.
Aaron Lazorwitz, MD, MSCS
Protocol Number: 19-2820
More information available at ClinicalTrials.gov: NCT04143659
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