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

PHASE4RecruitingINTERVENTIONAL
Enrollment

1,710

Participants

Timeline

Start Date

March 28, 2022

Primary Completion Date

July 31, 2026

Study Completion Date

March 31, 2027

Conditions
Change in Bone Mineral DensityBone Loss
Interventions
DRUG

LF111 (drospirenone 4 mg oral tablet) or drospirenone (DRSP) 3.5 mg chewable tablet

LF111 (drospirenone 4 mg tablet orally daily on days 1-24, followed by placebo tablet orally daily on days 25-28) or drospirenone (DRSP) 3.5 mg chewable tablet chewed daily on days 1-24, followed by placebo tablet chewed daily on days 25-28) (USA only). Subjects in the USA who choose to use the hormonal contraceptive method may choose between LF111 and DRSP 3.5 mg chewable tablets. The DRSP 3.5 mg chewable tablets are not available to subjects in Europe. Subjects in Europe who choose to use the hormonal contraceptive method will only receive LF111.

Trial Locations (20)

27612

RECRUITING

M3 Wake Research, Raleigh

30328

RECRUITING

M3 Wake Research, Inc., Sandy Springs

32750

RECRUITING

Cornerstone Research Institute, Longwood

33015

RECRUITING

Health Care Family Rehab & Research Center, Hialeah

33016

RECRUITING

Vital Pharma Research, Hialeah

33134

RECRUITING

Advanced Clinical Research Network, Coral Gables

33143

RECRUITING

Florida Pharmaceutical Research and Associates, Inc., South Miami

33186

RECRUITING

New Age Medical Research Corporation, Miami

33409

RECRUITING

Comprehensive Clinical Research, LLC, West Palm Beach

58104

RECRUITING

Lillestol Research LLC, Fargo

68701

RECRUITING

Meridian Clinical Research, Norfolk

70006

RECRUITING

Clinical Trials Management, LLC - Southshore, Metairie

70072

RECRUITING

Tandem Clinical Research, Marrero

76104

RECRUITING

Signature Gyn Services, Fort Worth

77054

RECRUITING

TMC Life Research, Inc., Houston

78412

RECRUITING

Corpus Christi Women's Clinic, Corpus Christi

80209

RECRUITING

Velocity Clinical Research, Denver

83704

RECRUITING

Family Care Research, Boise

85014

RECRUITING

Cactus Clinical Research, Inc., Phoenix

98105

RECRUITING

Seattle Clinical Research Center, Seattle

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Chemo Research

INDUSTRY

lead

Insud Pharma

INDUSTRY

NCT05303636 - LF111 or Drospirenone Chew vs Non-hormonal Contraceptive Methods on Bone Mineral Density in Adolescent and Adult Women | Biotech Hunter | Biotech Hunter