Oral Contraceptives and Body Mass Index

Phase 4 Completed 32 enrolled Oregon Health and Science University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab

RandomizedParallel-groupOpen-labelDiagnostic

Summary

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.

Timeline

Start: 2009-09
Primary completion: 2011-03
Completion: 2011-12

Publications

Edelman AB, Cherala G, Munar MY, McInnis M, Stanczyk FZ, Jensen JT. Correcting oral contraceptive pharmacokinetic alterations due to obesity: a randomized controlled trial. Contraception. 2014 Nov;90(5):550-6. doi: 10.1016/j.contraception.2014.06.033. Epub 2014 Jun 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levonorgestrel	Small molecule	0.1 mg	Oral
Subject	Levonorgestrel	Small molecule	0.15 mg	Oral
Subject	ethinyl estradiol	Small molecule	20 ug	Oral
Subject	ethinyl estradiol	Small molecule	30 ug	Oral

Indications

No indication recorded.