NCT01166412View on ClinicalTrials.gov

A Multi-center, Open-label, Randomized, Parallel Group Study to Evaluate Pharmacokinetic Profile, Effects on the Mechanisms of Contraceptive Efficacy and Safety of Two Progestin-only Patches Containing Different Doses of Levonorgestrel (LNG)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

121

Participants

Timeline

Start Date

December 31, 2010

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2012

Conditions
Contraception
Interventions
DRUG

levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2

6.5mg patch daily for 11 weeks

DRUG

levonorgestrel patch with BMI <32 kg/m2

6.5mg patch daily for 11 weeks

DRUG

levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2

12.5mg patch daily for 11 weeks

DRUG

levonorgestrel patch with BMI <32 kg/m2

12.5mg patch daily for 11 weeks

Trial Locations (6)

10032

Columbia University, New York

15213

Magee-Womens Hospital, Pittsburgh

19104

University of Pennsylvania Medical Center, Philadelphia

45267

University of Cincinnati College of Medicine, Cincinnati

80045

University of Colorado - Adv. Repro. Med., Aurora

97239

Oregon Health Sciences University, Portland

Sponsors

Lead Sponsor

Premier Research
All Listed Sponsors
collaborator

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

NIH

lead

Premier Research

OTHER

NCT01166412 - A Multi-center, Open-label, Randomized, Parallel Group Study to Evaluate Pharmacokinetic Profile, Effects on the Mechanisms of Contraceptive Efficacy and Safety of Two Progestin-only Patches Containing Different Doses of Levonorgestrel (LNG) | Biotech Hunter | Biotech Hunter