Efficacy, Safety, and Tolerability of LPRI-CF113 as an Oral Contraceptive in Females

PHASE3CompletedINTERVENTIONAL
Enrollment

1,542

Participants

Timeline

Start Date

August 2, 2022

Primary Completion Date

August 5, 2024

Study Completion Date

May 27, 2025

Conditions
ContraceptionChange in Bone Mineral Density
Interventions
DRUG

Drospirenone

LPRI-CF113 consists of 24 active white tablets containing drospirenone (DRSP) 4 mg followed by 4 active pink tablets containing DRSP 2.8 mg, taken orally once daily for 28 consecutive days, in consecutive cycles for 12 months (13 medication cycles) without a break in daily tablet intake.

Trial Locations (47)

19114

Clinical Research of Philadelphia, Philadelphia

20190

Virginia Women's Health Associates, Reston

23507

Eastern Virginia Medical School (EVMS), Norfolk

27103

Unified Women's Clinical Research - Winston-Salem, Winston-Salem

27607

Unified Women's Clinical Research - Raleigh, Raleigh

28562

Eastern Carolina Women's Center, New Bern

29405

Coastal Carolina Research Center, North Charleston

29607

The Research Center of the Upstate, Greenville

31406

Fellows Research Alliance, Savannah

32701

Cornerstone Research Institute - Longwood, Altamonte Springs

33012

Direct Helpers Research Center, Hialeah

33013

Inpatient Research Clinic, LLC, Hialeah

33016

Vital Pharma Research, Inc., Hialeah

33021

Encore Medical Research, LLC, Hollywood

33027

American Research Centers of Florida, Pembroke Pines

33030

Global Research Associates, Homestead

33155

Florida International Medical Research, Miami

33161

Segal Institute for Clinical Research, North Miami

33186

New Age Medical Research Corporation, Miami

SJ Research Institute, Miami

33331

Encore Medical Research of Weston LLC, Weston

33409

Comprehensive Clinical Trials, West Palm Beach

33436

Encore Medical Research of Boynton Beach LLC., Boynton Beach

33461

Altus Research, Lake Worth

33759

Women's Medical Research Group, Clearwater

35007

Alabama Clinical Therapeutics, LLC, Alabaster

35235

Alabama Clinical Therapeutics, LLC, Birmingham

37404

Chattanooga Medical Research, Chattanooga

43213

Clinohio Research Services, Columbus

44883

AC Clinical Research, Tiffin

70001

Southern Clinical Research Associates, Metairie

70072

Praetorian Pharmaceutical Research, Marrero

70127

Eastern Clinical Research Associates, New Orleans

75225

Discovery Clinical Trials, Dallas

76550

FMC Science, Lampasas

77054

TMC Life Research, Houston

77479

Mt. Olympus Medical Research- Sugar Land Texas, Sugar Land

77573

Maximos OB/GYN, League City

78229

Clinical Trials of Texas, LLC, San Antonio

78660

Austin Regional Clinic ARC Clinical Research at Kelly Lan, Pflugerville

78705

Central Texas Clinical Research, Austin

83404

Clinical Research Prime, Idaho Falls

Leavitt Clinical Research, Idaho Falls

Rosemark WomenCare Specialists, Idaho Falls

85715

Del Sol Research Management, Tucson

85745

Eclipse Clinical Research, Tucson

G1V 3M7

Clinique RS, Québec

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Chemo Research

INDUSTRY

lead

Insud Pharma

INDUSTRY

NCT05461573 - Efficacy, Safety, and Tolerability of LPRI-CF113 as an Oral Contraceptive in Females | Biotech Hunter | Biotech Hunter