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 range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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.
. 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.