A Study to Evaluate the Efficacy and Safety of Subcutaneous Levonorgestrel Butanoate for Female Contraception
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorPremier Research
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Levonorgestrel butanoate
Treatment groups
165 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Premier Research
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov