Safety and Efficacy of a Contraceptive Vaginal Ring Delivering Nestorone® and Ethinyl Estradiol

PHASE3CompletedINTERVENTIONAL
Enrollment

1,135

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
Contraception
Interventions
COMBINATION_PRODUCT

NES/EE CVR

This is a Phase 3, multicenter, open-label study of a 21/7-day regimen of the 150/15 NES/EE CVR, in healthy women followed on an outpatient basis up to one year (13 cycles) of treatment over one year. Because of the stop treatment date of December 31, 2008 for all participants, women enrolling or re-enrolling in 2008 may not complete a full 13 cycles of treatment. Subjects may also participate in a 6 month follow-up period after the 300B study. The ring is designed to last for 12 months.

Trial Locations (12)

10461

Montefiore Medical Center/Albert Einstein College of Medicine, The Bronx

43213

Columbus Center for Women's Heatlh Research, Columbus

60637

University of Chicago Hospitals, Chicago

90033

Women and Children's Hospital, LAC/USC Medical Center, Los Angeles

94110

University of California, San Francisco General Hospital, Department of Obstetrics & Gynecology, San Francisco

Unknown

FPA Health, Ashfield

University of Campinas, Department of Obstetrics & Gynecology, São Paulo

Instituto Chileno de Medicina Reproductiva, Santiago

Profamilia, Santo Domingo

Family Federation of Finland, Helsinki

University of Szeged, Department of Obstetrics & Gynecology, Szeged

SE 17176

Karolinska Institutet, Department of Woman and Child Health, Division of Obstetrics & Gynecology, Stockholm

All Listed Sponsors
collaborator

United States Agency for International Development (USAID)

FED

collaborator

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

NIH

collaborator

World Health Organization

OTHER

lead

Population Council

OTHER

NCT00263341 - Safety and Efficacy of a Contraceptive Vaginal Ring Delivering Nestorone® and Ethinyl Estradiol | Biotech Hunter | Biotech Hunter