NCT07222228

A Study to Evaluate the Efficacy and Safety of Subcutaneous Levonorgestrel Butanoate for Female Contraception

A Phase 2b Study to Evaluate the Efficacy and Safety of Subcutaneous Levonorgestrel Butanoate for Female Contraception

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: Premier Research · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

This is a multicenter, open-label, Phase 2b study to evaluate the efficacy and safety of 2 LB SQ injections administered at a 4-month (approximately 17 weeks) interval for female contraception.

Detailed description

This is a multicenter, open-label, Phase 2b study to evaluate the efficacy and safety of 2 LB SQ injections administered at a 4-month (approximately 17 weeks) interval for female contraception. The study plans to enroll approximately 165 female participants, 18 to 35 years of age, inclusive, at enrollment (Visit 2, Day 1), who have good general overall health. They also must have menstrual cycles of 21 to 35 days when not using hormonal contraception with typical variation in cycle length of 5 days or less, have an intact uterus and at least 1 ovary, expect to have heterosexual intercourse at least once per month during the study, and agree to use no additional methods of contraception during the study. Participants will be excluded if they are planning pregnancy during study participation through the End-of-Treatment Visit (Visit 11, Day 240). In addition, participants must have had 2 spontaneous menses (1 cycle) since delivery, 1 menses following first or second trimester abortion or miscarriage, must not be breastfeeding, or be within 30 days of discontinuing breastfeeding unless the participant has already had 1 cycle (2 menses) following discontinuation of breastfeeding. The primary aim of the study is to evaluate the contraceptive efficacy of LB SQ injections over 8 cycles. Additionally, LB safety will be assessed based on the incidence of AEs (including weight increase) and injection site reactions and changes from baseline laboratory parameters. The number of bleeding and spotting days per 30-, 90-, and 120-day intervals, as well as responses from the acceptability and satisfaction questionnaire at Day 240 (Month 8), are also secondary endpoints of the study.

Conditions

• Healthy Women
• Female Contraception

Interventions

Type	Name	Description
DRUG	Levonorgestrel butanoate	60 mg SQ (70 mg/mL)

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-12-31
• Completion: 2029-03-31
• First posted: 2025-10-29
• Last updated: 2025-10-29

Regulatory

• FDA-regulated drug study