Clinical trial NCT00827632: Obesity, Oral Contraception, and Ovarian Suppression
Official title: Oral Contraception and Ovarian Suppression in Women With Different Weights
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ovarian Suppression
Keywords: Ovarian Suppression
Oral Contraceptives
Obese and Normal BMI
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2009-01-23
Enrollment: 226
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: There is a large gap between lowest expected failure rates of about 1.5% and typical use failure rates of about 7% per year. This gap may be due to incorrect use or to decreased oral contraceptive (OC) effectiveness in population subgroups. Recent reports suggest greater OC failure among heavier women, particularly those using the lowest doses. The prevalence of obesity in the US population has recently increased to about 23% in women aged 20-29, peak years for OC use. OC physiology and effectiveness have not been evaluated in obese women.

Eligibility criteria: Inclusion Criteria:

* Aged 18-35
* Body Mass Index (BMI) 19-24.9 or 30-39.9 kg/m\^2
* Willing to take birth control pills for 3-4 months
* Recent spontaneous pregnancy or cyclic menses

Exclusion Criteria:

* Contraindications to hormonal contraceptives
* Oophorectomy/Polycystic ovary syndrome (PCOS)
* Taken oral contraceptives to regulate menses recently
* Weight reduction surgery
* Used Depo-Provera within the last 12 months
* Pregnant or currently breastfeeding
* Desiring pregnancy within the next 4 months
* Unable to make study visit commitment
* Previous participation in this study

Primary outcomes:
measure: Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression.
timeFrame: Up to 8 biweekly visits from start of OCP therapy
Secondary outcomes:
measure: Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users at Baseline and Exit Visit (12-16 Weeks OC Exposure).
timeFrame: Screening (baseline) and follow-up 1 (exit)
measure: Pharmacokinetics of 15 Obese Weight and 15 Normal Weight Women on Combined Oral Contraceptives.
timeFrame: 24 hours during week 3 of follow-up cycle
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Carolyn Westhoff, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.