LF111 or Drospirenone Chew vs Non-hormonal Contraceptive Methods on Bone Mineral Density in Adolescent and Adult Women (NCT05303636)
A Multicenter, Open-label, Controlled Study to Investigate the Effect of Either LF111 or Drospirenone Chewable Tablets on Bone Mineral Density (BMD) in Adolescent and Adult Women in Comparison With Non-users of Hormonal Contraceptive Methods
🩺 Plain-English Summary (8th-Grade Level)
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 LF111 and DRSP 3.5 mg chewable tablets on body fat and lean mass after 12 months (13 medication cycles) of investigation.
Who can join: Review the eligibility criteria below.
Location: Phoenix Childrens Hospital — Phoenix, Arizona
Age range: 14 Years to 45 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (37 Sites)
Showing the first 25 of 37 sites.
- Phoenix Childrens Hospital — Phoenix, Arizona
- University of Colorado Denver - School of Medicine - Anschutz Medical Campus — Aurora, Colorado
- Encore Medical Research of Boynton Beach LLC — Boynton Beach, Florida
- Advanced Clinical Research Network — Coral Gables, Florida
- BioMD Research — Coral Gables, Florida
- Direct Helpers Research Center — Hialeah, Florida
- Health Care Family Rehab & Research Center — Hialeah, Florida
- Vital Pharma Research — Hialeah, Florida
- Encore Medical Research, LLC — Hollywood, Florida
- Cornerstone Research Institute — Longwood, Florida
- D&H National Research Centers — Miami, Florida
- Miami Clinical Research — Miami, Florida
- Felicidad Medical Research, LLC — Miami, Florida
- New Age Medical Research Corporation — Miami, Florida
- KM International Research Operation LLC — Saint Cloud, Florida
- Florida Pharmaceutical Research and Associates, Inc. — South Miami, Florida
- Encore Medical Research of Weston LLC — Weston, Florida
- Clinical Trials Management, LLC - Southshore — Metairie, Louisiana
- University of Michigan C.S. Mott Children's Hospital — Ann Arbor, Michigan
- Meridian Clinical Research — Norfolk, Nebraska
- Lillestol Research LLC — Fargo, North Dakota
- OB/GYN Associates of Erie — Erie, Pennsylvania
- Signature Gyn Services — Fort Worth, Texas
- TMC Life Research, Inc. — Houston, Texas
- Tidewater Clinical Research, Inc. — Norfolk, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Change in Bone Mineral Density clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.