Clinical trial NCT01170390: Oral Contraceptives and Body Mass Index
Official title: Improving Contraceptive Effectiveness in Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Body Weight
Contraceptive Usage
Keywords: Obesity
Body weight
Oral contraception
Efficacy
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2010-07-27
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age 18-35
* BMI \> 30kg/m2
* Proof of a normal breast and pelvic exam within last 9 months
* Self reported normal menstrual periods (24-35 days)
* Good general health
* In the investigator's opinion, are subject's veins suitable the repeat blood draws dictated by study protocol
* Single progesterone level during screening visit ≥ 3ng/mL
* Hematocrit ≥ 36%

Exclusion Criteria:

* Contradictions to COCs (history of deep vein thrombosis,myocardial infection, uncontrolled hypertension, pulmonary embolus, diabetes with vascular changes, stroke, migraines with neurologic changes, breast cancer, impaired liver function, uncontrolled thyroid disease, hypersensitivity or allergy to birth control)
* Smoker (must smoke 0 cigarettes)
* Actively seeking/involved in a weight loss program
* Currently pregnant/seeking pregnancy in the next 6 months
* Currently breast-feeding
* Past or current diagnosis of polycystic ovarian disease
* Recent use of birth control (Depot medroxyprogesterone: 6 months, Progestin implants: 6 months, Oral contraceptives, patch or ring: 2 months, Hormone impregnated IUD: 6 months)
* Currently taking medication that interferes with COC's (Rifampin, Carbamazepine, St. John's Wort)

Primary outcomes:
measure: LNG Steady State at Baseline and Then Post-randomization
timeFrame: baseline (2 months) and post-randomization (4 months)
Secondary outcomes:
measure: LNG AUC
timeFrame: post-randomization (4 months)
measure: LNG AUC
timeFrame: baseline (2 months)
measure: EE Steady State Baseline
timeFrame: Baseline (2 months)
measure: EE Steady State After Randomization
timeFrame: Post-randomiziation 4 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Alison Edelman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.