Oral Contraceptives and Body Mass Index

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 4

Conditions: Contraceptive Usage; Body Weight

Treatments: Drug: All participants (Aviane); Drug: Portia; Drug: Aviane

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01170390

R01HD061582 (U.S. NIH Grant/Contract)

OHSU FAMPLAN 5382

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

32 participants in 3 patient groups

All participants

Other group

Description:

A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days).

Treatment:

Drug: All participants (Aviane)

Aviane and Portia

Active Comparator group

Description:

A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles

Treatment:

Drug: Portia

Aviane & Aviane

Active Comparator group

Description:

A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)

Treatment:

Drug: Aviane