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A Phase I study to evaluate the pharmacokinetic and pharmacodynamic profile of intramuscular or subcutaneous injections of levonorgestrel butanoate (LB) for female contraception

Primary Objective

This study is studying levonorgestrel butanoate (LB) as a possible long-acting and reversible injectable formulation for female contraception.

Study

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Description

Your participation in the study would include up to 36 clinic visits over a 9-month period. During your time in the study, you will have physical exams, pelvic exams, breast exams, vital sign assessments, blood tests, pregnancy tests, and possibly a PAP smear. You will also have transvaginal ultrasounds of your ovaries to determine if you are at risk for pregnancy during the study. In addition, you will also be asked about your complete medical history, including your gynecological, menstrual, reproductive and sexual history.

Details
Age

Adult

Eligibility

Women who join the study should be generally healthy with no chronic medical conditions, 18 through 40 years old, and have a regular menstrual cycle that starts every 21-35 days. They should have a uterus and at least one ovary. To join the study, you should not be pregnant and must not have had any unprotected heterosexual intercourse during the previous 10 days. You cannot be at risk for pregnancy during the duration of the study.

Detailed Eligibility: 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.

Phase

I - Research Studies that focus on the safety of a drug. The goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These studies usually involve a small number of participants.

Type of Study

Outcomes Research

Location

Comprehensive Women's Health Center

Principal Investigator
Stephanie Teal

Stephanie Teal

Study ID

Protocol Number: 19-2820

ClinicalTrials.gov: NCT04143659

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