WOMEN’S HEALTH · CONTRACEPTION
LF111 Drospirenone Bone-Mineral-Density Study
A Phase 4 study comparing bone-mineral-density changes with drospirenone contraception and nonhormonal methods.
Study overview
This prospective, multicenter, open-label, controlled Phase 4 study examines bone mineral density in postmenarcheal adolescents and premenopausal adult women. Participants choosing LF111 or drospirenone 3.5 mg chewable tablets are compared with participants choosing nonhormonal contraception. The study is nonrandomized because participants select the contraception approach with appropriate clinical guidance. Separate adolescent and adult cohorts support age-appropriate analysis.
What researchers are evaluating
The primary assessments examine change in lumbar-spine bone mineral density after approximately 12 months of study participation. Researchers also evaluate bone density at other sites, bone turnover measures, body composition, safety, and tolerability. Bone density is measured with dual-energy X-ray absorptiometry, commonly called DXA. Study visits may include medical and medication reviews, pregnancy testing, physical assessments, laboratory work, DXA scans, and monitoring for adverse events. Drospirenone has prescribing restrictions and potential risks that qualified staff review before treatment.
Considering participation
Potential eligibility may depend on age, menstrual and reproductive history, contraceptive choice, bone health, current medicines, kidney, liver or adrenal function, blood-clot history, cancer history, pregnancy-related requirements, and other protocol criteria. The ClinicalTrials.gov record currently describes this study as active but not recruiting; local status must always be confirmed and may change. This page does not recommend a contraceptive method or determine whether treatment is appropriate. Participation is voluntary, and informed consent or assent explains study groups, scans, visits, foreseeable risks, possible benefits, alternatives, confidentiality, and withdrawal rights. Participants may discuss contraception choices with their own qualified clinician before deciding. Do not submit medical records, pregnancy information, insurance details, or other sensitive health information in an initial inquiry.