A Study to Evaluate the PK and PD of IM or SQ Injections of Levonorgestrel Butanoate (LB) for Fem… (NCT04143659) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Evaluate the PK and PD of IM or SQ Injections of Levonorgestrel Butanoate (LB) for Female Contraception
United States136 participantsStarted 2020-03-03
Plain-language summary
This is a Phase I multicenter, open-label, dose-ranging, three-dose PK and PD study of injectable LB administered as an IM or SQ injection at 40 mg, and subsequently at 50mg SQ and then 60 mg SQ depending on the preliminary pharmacokinetic and pharmacodynamic results obtained with 40 mg dosing.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Good general health with no chronic medical conditions that result in periodic exacerbations that require significant medical care.
✓. Age between 18 and 40 years inclusive at the injection visit.
✓. BMI \< 40 kg/m2.
✓. Intact uterus with at least one ovary.
✓. 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.
✓. Regular menstrual cycles that occur every 21-35 days:
Exclusion criteria
✕. Known hypersensitivity or contraindication to progestins.
✕. Abnormal Transvaginal Ultrasound (TVUS) or safety labs done during the screening period recognized as clinically significant by the investigator (or medically qualified designee).
✕. Greater than 10% body weight change over previous year or planned significant weight loss during the study related to bariatric surgery, dieting or other causes.
✕. Known or suspected current alcohol dependence syndrome, chronic marijuana use or any illicit drug use that may affect metabolism of the study product or study compliance.
✕. Undiagnosed abnormal genital bleeding.
What they're measuring
1
Measurement of levonorgestrel serum concentrations
Timeframe: 0, 2, 4, 6, 8, 24, 48, 96, 168, and 240 hours. Then weekly for up to 26 weeks.
✕. Undiagnosed vaginal discharge, lesions or abnormalities. Subjects diagnosed at screening with Chlamydia, or gonococcus infection may be included in the trial following treatment completion. In accordance with PI/medical designee assessment and local standards of practice, women with a history of genital herpes can be included if outbreaks are infrequent. Antiviral prophylactic therapy is permitted.
✕. Uncontrolled thyroid disorder.
✕. Current use of hormonal contraception including hormonal intrauterine device.