Oral Contraceptives and Body Mass Index

Condition(s) targeted: Body Weight; Contraception

Intervention: Alesse (Drug); Levora (Drug); Midazolam (Drug); Tolbutamide (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Oregon Health and Science University

Official(s) and/or principal investigator(s):
Alison Edelman, MD, MPH, Principal Investigator, Affiliation: Oregon Health and Science University

Overall contact:
Women's Health Research Confidential Recruiting Line, Phone: 503-494-3666, Email: whru@ohsu.edu

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.

Official title: Improving Contraceptive Effectiveness in Obese Women

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: To determine if alternative dosing regimens result in improved pharmacokinetic parameters and ovarian suppression and similar safety biomarkers in obese women.

Secondary outcome: To confirm obesity-related differences in the pharmacokinetics of orally-dosed combined hormonal contraceptives.

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.

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

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)

Women's Health Research Confidential Recruiting Line, Phone: 503-494-3666, Email: whru@ohsu.edu

Oregon Health and Science University, Portland, Oregon 97239, United States; Recruiting
Alison Edelman, MD, MPH, Principal Investigator
Jeffrey Jensen, MD, MPH, Sub-Investigator
Mark Nichols, MD, Sub-Investigator
Paula Bednarek, MD, MPH, Sub-Investigator
Rosanne Botha, MD, Sub-Investigator
Marci Messerle Forbes, FNP, Sub-Investigator
Andrea O'Donnell, FNP, Sub-Investigator

(OHSU Women's Health Research Unit)

Starting date: September 2009
Last updated: July 26, 2010