drugset / Trial / NCT00827632
Obesity, Oral Contraception, and Ovarian Suppression
Phase 4
Completed
226 enrolled
Columbia University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This study proposes a double blind randomized clinical trial to include normal weight and obese women who have normal ovulatory function at baseline; the investigators will randomize women to 2 widely used OCs and evaluate ovarian follicle development and circulating progesterone to assess ovarian suppression during OC use.
Timeline
- Start
- 2006-07
- Primary completion
- 2008-12
- Completion
- 2008-12
Publications
- Mayeda ER, Torgal AH, Westhoff CL. Weight and body composition changes during oral contraceptive use in obese and normal weight women. J Womens Health (Larchmt). 2014 Jan;23(1):38-43. doi: 10.1089/jwh.2012.4241. Epub 2013 Oct 24.
- Westhoff CL, Torgal AH, Mayeda ER, Stanczyk FZ, Lerner JP, Benn EKT, Paik M. Ovarian suppression in normal-weight and obese women during oral contraceptive use: a randomized controlled trial. Obstet Gynecol. 2010 Aug;116(2 Pt 1):275-283. doi: 10.1097/AOG.0b013e3181e79440.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Levonorgestrel | Small molecule | 100 ug | Oral |
| Comparator | Levonorgestrel | Small molecule | 150 ug | Oral |
| Comparator | ethinyl estradiol | Small molecule | 20 ug | Oral |
| Comparator | ethinyl estradiol | Small molecule | 30 ug | Oral |