Improving Contraceptive Effectiveness in Obese Women

NCT01170390 Phase 4 COMPLETED Results posted

The main hypothesis for this study is that increased Body Mass Index (BMI) alters oral contraceptive metabolism in a manner which results in decreased effectiveness in obese women.

Details

Lead sponsor	Oregon Health and Science University
Phase	Phase 4
Status	COMPLETED
Enrolment	32
Start date	2009-09
Completion	2011-12

Conditions

• Body Weight
• Contraceptive Usage

Interventions

• All participants (Aviane)
• Portia
• Aviane

Primary outcomes

• LNG Steady State at Baseline and Then Post-randomization — baseline (2 months) and post-randomization (4 months)
  The main goal is to test whether key pharmacokinetic parameters of levonordestrel (LNG) differ between obese women taking traditionally dosed OCs versus the interventional arms (i.e. using each obese subject as their own control).

Countries

United States