Efficacy, Safety, and Tolerability of LPRI-CF113 as an Oral Contraceptive in Females
Completed · Phase 3 · NCT05461573
Conditions: Contraception, Change in Bone Mineral Density
At a glance
- Research payments reported, 2025
- $1.5M
- U.S. investigators named
- 44
- Sites paid
- 32
- Planned or actual enrollment
- 1,542
About the trial
- Sponsor
- Insud Pharma (with Chemo Research)
- Tested
- Drospirenone (drug)
- Dates
- Started 2022-08-02; completion 2025-05-27
- Results posted
- Not yet
This study will be in two parts, Part A and Part B. The primary objective of Part A is to evaluate the contraceptive efficacy of LPRI-CF113. The secondary objective of Part A is to evaluate the safety and tolerability of LPRI-CF113. The primary objective of Part B is to evaluate the impact of LPRI-CF113 on bone mineral density (BMD) at the lumbar spine (L1-L4) after 12 months (13 medication cycles). The secondary objective of Part B is to evaluate the impact of LPRI-CF113 on BMD and bone turnover after 12 months (13 medication cycles) at the femoral neck, total hip, and total body.
From ClinicalTrials.gov, last updated 2025-10-08. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Exeltis, USA Inc. reported $1.5M in research payments for this study in 2025 (265 payments).
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.
U.S. investigators named on this study
- Ronald W. Orso, MD OB-GYN (Obstetrics & Gynecology) · Birmingham, AL
- Earl M. Simmons III, MD OB-GYN (Obstetrics & Gynecology) · Alabaster, AL
- Catherine P. Brainard, MD OB-GYN (Obstetrics & Gynecology) · Tucson, AZ
- Ronald T. Ackerman SR., MD OB-GYN (Obstetrics & Gynecology) · West Palm Beach, FL
- Gerard F. Acloque JR., M.D. Internal Medicine · Hollywood, FL
- Jude A. Acloque, M.D. Internal Medicine · Boynton Beach, FL
- Michael Akpeke, MD Internal Medicine · Orlando, FL
- Sandro Bacchelli, MD Family Medicine · Hollywood, FL
- Celestino P. Castellon, MD PA OB-GYN (Obstetrics & Gynecology) · Hialeah, FL
- Jose A. Cobiella, M.D. PA Internal Medicine · Homestead, FL
- Karen Figueredo Reyes, MD Family Medicine · Palmetto Bay, FL
- Rafael E. Garcia-ocasio, M.D OB-GYN (Obstetrics & Gynecology) · Hialeah, FL
- Janet K. Gersten, M.D. OB-GYN (Obstetrics & Gynecology) · Miami, FL
- Harvey A. Glasser, MD OB-GYN (Obstetrics & Gynecology) · Aventura, FL
- George L. Herrera, M.D OB-GYN (Obstetrics & Gynecology) · Doral, FL
- Erick Juarez, M.D. Family Medicine · Miami, FL
- Samuel N. Lederman, M.D. OB-GYN (Obstetrics & Gynecology) · Lake Worth, FL
- Jorge Pando, M.D. FACOG Specialist · Miami Lakes, FL
- Mark D. Sanchez, M.D. Fertility (Reproductive Endocrinology) · Tampa, FL
- Jeffrey B. Baker, M.D. Family Medicine · Idaho Falls, ID
- Glenn R. Leavitt, DO OB-GYN (Obstetrics & Gynecology) · Idaho Falls, ID
- Steven W. Robison, MD OB-GYN (Obstetrics & Gynecology) · Idaho Falls, ID
- Samuel M. Alexander, M.D. OB-GYN (Obstetrics & Gynecology) · Metairie, LA
- Clifton S. Nicholson-uhl, M.D OB-GYN (Obstetrics & Gynecology) · Marrero, LA
- Brandon L. Perez, M.D. OB-GYN (Obstetrics & Gynecology) · Marrero, LA
- Ann S. Collins, MD OB-GYN (Obstetrics & Gynecology) · Raleigh, NC
- Jeffrey A. Michelson, M.D. OB-GYN (Obstetrics & Gynecology) · New Bern, NC
- Robert L. Parker JR., MD OB-GYN (Obstetrics & Gynecology) · Winston-salem, NC
- Abner Cordero, M.D. OB-GYN (Obstetrics & Gynecology) · Tiffin, OH
- Harold N. Green, MD OB-GYN (Obstetrics & Gynecology) · Columbus, OH
- Eugene Andruczyk, D.O. OB-GYN (Obstetrics & Gynecology) · Philadelphia, PA
- Harlicia Farley, MD Family Medicine · Greenville, SC
- Heather S. Schwartzberg, MD OB-GYN (Obstetrics & Gynecology) · Summerville, SC
- Patricia A. Thompson, MD OB-GYN (Obstetrics & Gynecology) · Beaufort, SC
- Daniel S. Harnsberger, M.D. OB-GYN (Obstetrics & Gynecology) · Chattanooga, TN
- Valentin Almendarez JR., M.D. OB-GYN (Obstetrics & Gynecology) · San Antonio, TX
- Cynthia C. Brinson, M.D. Family Medicine · Austin, TX
- Vanna S. Gold, D.O. Family Medicine · Lampasas, TX
- Kristen J. Hansen-peterman, MD OB-GYN (Obstetrics & Gynecology) · Austin, TX
- Mark A. Jacobs, M.D. OB-GYN (Obstetrics & Gynecology) · Houston, TX
- Bassem Maximos, MD, MPH, PA OB-GYN (Obstetrics & Gynecology) · League City, TX
- A. J. Staub, M.D. OB-GYN (Obstetrics & Gynecology) · Dallas, TX
- Harish N. Thakkar, M.D. Internal Medicine · Sugar Land, TX
- Camilla C. Hersh, M.D. OB-GYN (Obstetrics & Gynecology) · Reston, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Encore Medical Research of Weston LLC $244,060
- Elias Research Associates LLC $211,561
- Encore Medical Research LLC $161,976
- Inpatient Research Clinic LLC $137,049
- Florida International Medical Research LLC $117,403
- Encore Medical Research of Boynton Beach LLC $102,359
- New Age Medical Research Corporation $84,634
- Global Research Associates LLC $69,727
- Interspond LLC $64,197
- Elligo Health Research Inc $47,978
- Del Sol Research Management LLC $30,473
- Unified Women's Clinical Research $22,089
- Cornerstone Research Institute $22,053
- Innovation Medical Research Center Inc $21,260
- Tmc Life Research Inc $18,397
- Fellows Research Alliance Inc $18,195
- Clinical Research Philadelphia LLC $15,374
- Abner Cordero $14,706
- Clinical Trials of Texas LLC $14,462
- Chattanooga Medical Research LLC $14,319
- Dct-Hcwcllc DBA Discovery Clinical Trials $13,760
- Coastal Carolina Research Center LLC $10,519
- Bassem Maximos MD Mph PA $9,734
- Gmg Clinical Research LLC $8,751
- The Research Center of the Upstate $8,611
- Women's Healthcare Associates $8,292
- Medisync Clinical Research LLC $4,866
- Altus Clinical Research LLC $4,739
- Comprehensive Clinical Research LLC $2,984
- Mt Olympus Medical Research $1,100
- Emad Ghaly DBA Focus Clinical Research Solutions LLC $850
- Women's Medical Research Group $850
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.