Status:
NOT_YET_RECRUITING
A Study to Evaluate the Efficacy and Safety of Subcutaneous Levonorgestrel Butanoate for Female Contraception
Lead Sponsor:
Premier Research
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Healthy Women
Female Contraception
Eligibility:
FEMALE
18-35 years
Phase:
PHASE2
Brief 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 st...
Eligibility Criteria
Inclusion
- Participant understands and signs an ICF approved by the institutional review board prior to any screening activities.
- Female and 18 to 35 years of age, inclusive, at enrollment (Visit 2, Day 1).
- Good general overall health with no chronic medical conditions that result in periodic exacerbations requiring significant medical care.
- Menstrual cycles of 21 to 35 days in length with typical variation in cycle length of 5 days or less when not using hormonal contraception.
- Intact uterus and at least 1 ovary.
- If used a hormonal contraceptive or intra-uterine device (IUD) prior to enrollment, the participant meets the appropriate criteria for time since last use:
- Oral, transdermal, vaginal, copper or LNG IUD or implantable hormonal contraceptives: participants must have discontinued hormone use ≥4 days prior to start of study treatment, experienced bleeding that is consistent with menses in the opinion of the investigator and not have had unprotected intercourse since discontinuing the method.
- Injectable contraception (e.g., DMPA): No injection during the 10 months prior to the Screening Visit, unless the participant has returned to normal menses (i.e., 2 consecutive menses) since last injection.
- Negative urine pregnancy test at enrollment (Visit 2, Day 1).
- Body mass index \<40 kg/m2.
- Willing to use the study method as the primary method of contraception until the end of the Treatment Period.
- At risk for pregnancy defined as:
- Expecting to have ≥1 act of heterosexual intercourse each month during study participation until the end of the Treatment Period.
- No medical history suggesting possible infertility or hypofertility, including but not limited to, ectopic pregnancy or pelvic infection (unless has had a subsequent intra-uterine pregnancy).
- Has a sexual partner with no known problems with infertility orhypofertility.
Exclusion
- Planning pregnancy during study participation through the End -of -Treatment Visit (Visit 11, Day 240).
- Is post-partum and has not had 2 spontaneous menses (1 cycle) since delivery or 1 menses since first or second trimester abortion or miscarriage.
- Breastfeeding or within 30 days of discontinuing breastfeeding unless the participant has already had 2 menses (1 cycle) following discontinuation of breastfeeding.
- Undiagnosed abnormal genital bleeding.
- Undiagnosed vaginal discharge, lesions, or abnormalities.
- Participating in another clinical study involving an IP or device within 30 days prior to the Screening Visit or planning to participate in another clinical study during this study.
- Not living in the catchment area of the study site.
- Known hypersensitivity or contraindication to progestins, including the active substance LB or any excipients of the study treatment.
- Current need for therapeutic anticoagulation or known history of thrombophilia.
- Use or planned use of exogenous reproductive hormones during study participation.
- Body weight change exceeding 10% over the previous year or planned significant weight loss during the study related to bariatric surgery, dieting, or planned treatment.
- Uncontrolled hypertension, in which diastolic blood pressure remains ≥95 mmHg or systolic blood pressure remains ≥145 mmHg.
- Smoking nicotine (e.g., cigarettes or electronic cigarettes) AND has at least 1 of the following comorbidities or conditions (at the discretion of the investigator):
- Current or history of venous thrombophlebitis or thromboembolic disorders (including deep vein thrombosis and pulmonary embolism).
- Current or history of cerebrovascular or coronary-artery disease.
- Valvular heart disease with thrombogenic complications.
- Diabetes with vascular involvement.
- Known inherited or acquired predisposition to venous thromboembolism or arterial thromboembolism (e.g., factor VLeiden, prothrombin mutation, antiphospholipid antibodies) or bruising within the last 12 months prior to consent.
- Current or past cerebrovascular or cardiovascular disease or at risk of clotting disorders.
- Impaired mobility (e.g., is wheelchair bound or bedridden) that, in the investigator's opinion, places the participant at increased risk of thrombosis.
- Known or suspected carcinoma of the breast or suspected progestin-dependent neoplasia.
- Known or suspected pelvic organ carcinoma.
- Known Papanicolaou (Pap) or human papillomavirus (HPV) test abnormality that would require a repeat evaluation or treatment during study participation based on standard of care guidelines (American Society for Colposcopy and Cervical Pathology or American College of Obstetricians and Gynecologists).
- Known benign or malignant liver tumors, renal disease, or active liver disease.
- Invasive cancer (past history of any carcinoma or sarcoma, except non-melanoma skin cancer) unless in remission for \>5 years.
- Current or past medically diagnosed severe depression, which, in the investigator's opinion, could be exacerbated by use of a hormonal contraceptive, unless participant is on stable antidepressant medication.
- Known or suspected current alcohol dependence syndrome or any recreational drug use that may affect metabolism of the IP or study compliance.
- Abnormal screening laboratory values defined as:
- Fasting clinical chemistry values or CBC values designated clinically significant by the investigator.
- Liver function test results \>twice the upper limit of normal.
- Uncontrolled thyroid disorder.
Key Trial Info
Start Date :
April 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2029
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT07222228
Start Date
April 1 2026
End Date
March 31 2029
Last Update
October 29 2025
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