LF111 or Drospirenone Chew vs Non-hormonal Contraceptive Methods on Bone Mineral Density in Adolescent and Adult Women

About the trial

Sponsor

Insud Pharma (with Chemo Research)

Tested

drospirenone 4 mg oral tablet or drospirenone 3.5 mg chewable tablet (drug)

Dates

Started 2022-03-28; completion 2028-06

Results posted

Not yet

The primary objective of this study is to evaluate the impact of LF111 and drospirenone (DRSP) 3.5 mg chewable tablets on bone mineral density (BMD) at the lumbar spine after 12 months (13 medication cycles) of investigation in comparison to non-hormonal contraceptive methods. Secondary objectives include further evaluating the impact of LF111 and DRSP 3.5 mg chewable tablets on BMD and bone turnover after 12 months (13 medication cycles) in comparison to non-hormonal contraceptive methods and assessing the general safety and tolerability of LF111 and DRSP 3.5 mg chewable tablets in comparison to non-hormonal contraceptive methods. Exploratory objectives include evaluating the impact of L…

From ClinicalTrials.gov, last updated 2026-04-09. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Exeltis, USA Inc. reported $3.2M in research payments for this study in 2025 (592 payments).

Products named: Slynd

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.