NCT01170390

Oral Contraceptives and Body Mass Index

Improving Contraceptive Effectiveness in Obese Women

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is being conducted to understand how effective oral hormonal birth control (the pill) is for women with high body mass index ("BMI" - the ratio of your height and weight BMI"). Previous studies of birth control traditionally do not include women above a certain BMI number, so safety and efficacy is not clearly understood in this population, yet the pill is still widely used in women with high BMI. Reproductive-aged, ovulatory women of obese (BMI \>30 kg/m2), will be placed on oral contraceptives for 2 months, then randomized into two intervention arms for an additional 2 months. At several key time points, synthetic steroid pharmacokinetics, gonadotropins (LH, FSH) and ovarian hormone levels (estradiol, progesterone), ovarian follicular activity by ultrasound monitoring, and cervical mucus testing will be monitored.

Conditions

• Body Weight
• Contraceptive Usage

Interventions

Type	Name	Description
DRUG	All participants (Aviane)	20 mcg EE/0.1 mg LNG cyclically
DRUG	Portia	30 mcg EE/0.15 mg LNG cyclically
DRUG	Aviane	20 mcg EE/0.1 mg LNG continuously dosed

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-03-01
• Completion: 2011-12-01
• First posted: 2010-07-27
• Last updated: 2015-12-31
• Results posted: 2015-11-26

Locations

1 site across 1 country: United States