A Dose-finding Study to Evaluate the Effect of a Contraceptive Vaginal Ring, Releasing Nestorone® and Estradiol, on Cycle Control, Ovulation Inhibition, and Pharmacokinetics in Normal Cycling Women

PHASE2CompletedINTERVENTIONAL
Enrollment

197

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

May 31, 2015

Study Completion Date

May 31, 2015

Conditions
Suppression of Ovulation
Interventions
DRUG

10 µg/day E2 with NES 200® µg/day

10 µg/day E2 with NES 200® µg/day delivered by CVR continuously for 6 months (180 days)

DRUG

20 µg/day E2 with NES 200® µg/day

20 µg/day E2 with NES 200® µg/day delivered by CVR continuously for 6 months (180 days)

DRUG

40 µg/day E2 with NES 200® µg/day

40 µg/day E2 with NES 200® µg/day delivered by CVR continuously for 6 months (180 days)

Trial Locations (8)

10016

NYU School of Medicine, New York

10032

Columbia University, New York

15213

Univeristy of Pittsburgh School of Medicine, Pittsburgh

19104

University of Pennsylvania School of Medicine, Philadelphia

21224

Johns Hopkins School of Medicine, Baltimore

23507

Eastern Virginia Medical School, Norfolk

45267

University of Cincinnati, Cincinnati

97239

Oregon Health & Science University, Portland

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Premier Research

OTHER