Safety, Efficacy, Tolerability and Pharmacokinetics of LF111 (Drospirenone 4.0 mg) During 13 Cycles

PHASE3CompletedINTERVENTIONAL
Enrollment

1,552

Participants

Timeline

Start Date

October 9, 2014

Primary Completion Date

October 4, 2017

Study Completion Date

October 4, 2017

Conditions
Contraception
Interventions
DRUG

LF111 (drospirenone)

One LF111 tablet once per day for 24 days followed by 4 placebo tablets for 4 days equals one cycle.

Trial Locations (37)

10016

NYU School of Medicine, New York

19104

University of Pennsylvania School of Medicine, Philadelphia

19114

Clinical Research Of Philadelphia, Philadelphia

21224

Johns Hopkins School of Medicine, Baltimore

23507

Eastern Virginia Medical School, Norfolk

27103

Hawthorne Medical Research, Inc., Winston-Salem

27612

Wake Research Associates, Raleigh

28562

Eastern Carolina Women's Center, New Bern

29910

Fellows Research Alliance, Inc., Bluffton

31406

Fellows Research Alliance, Inc., Savannah

33143

Miami Research Associates, Miami

33161

Segal Institute for Clinical Research, North Miami

33409

Comprehensive Clinical Trials, LLC, West Palm Beach

33461

Altus Research, Lake Worth

33606

Meridien Research - Tampa, Tampa

33709

Meridien Research - St. Petersburg, St. Petersburg

35235

Alabama Clinical Therapeutics, Birmingham

40291

Bluegrass Clinical Research, Inc, Louisville

43213

Columbus Obstetricians-Gynecology, Inc./Radiant Research, Inc., Columbus

45267

University of Cincinnati, Cincinnati

49009

Beyer Research, Kalamazoo

75230

Practice Research Organization, Dallas

77054

TMC Life Research, Inc., Houston

78414

Advanced Research Associates, Corpus Christi

80209

Downtown Women's Health Care, Denver

80220

Horizons Clinical Research Center, LLC, Denver

83404

Rosemark WomenCare Specialists, Idaho Falls

84020

Physicians' Research Options, Draper

84062

Physicians' Research Options, Pleasant Grove

87109

Southwest Clinical Research, Albuquerque

92123

Women's Health Care Research Corp., San Diego

92626

WCCT Global, Costa Mesa

92801

Anaheim Clinical Trials, LLC, Anaheim

98105

Seattle Women's Health, Research, Gynecology, Seattle

06095

Stamford Therapeutics Consortium, Stamford

08648

Lawrence OBGYN Clinical Research, LLC, Lawrenceville

08536

The Center for Women's Health & Wellness, LLC, Plainsboro

All Listed Sponsors
collaborator

Chemo France

INDUSTRY

lead

Laboratories Leon Farma, S.A.

INDUSTRY

NCT02269241 - Safety, Efficacy, Tolerability and Pharmacokinetics of LF111 (Drospirenone 4.0 mg) During 13 Cycles | Biotech Hunter | Biotech Hunter