Oral Contraceptives and Body Mass Index

Oregon Health and Science University32 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Body Weight Contraceptive Usage

Interventions

All participants (Aviane)DRUG

20 mcg EE/0.1 mg LNG cyclically

PortiaDRUG

30 mcg EE/0.15 mg LNG cyclically

AvianeDRUG

20 mcg EE/0.1 mg LNG continuously dosed

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Oregon Health and Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

LNG Steady State at Baseline and Then Post-randomization

The main goal is to test whether key pharmacokinetic parameters of levonordestrel (LNG) differ between obese women taking traditionally dosed OCs versus the interventional arms (i.e. using each obese subject as their own control).

Time frame: baseline (2 months) and post-randomization (4 months)

Secondary Outcomes

LNG AUC

Area under the curve post-randomization for levonorgestrel. AUC was calculated and extrapolated using post randomization in single daily samples drawn during Cycle 4 days 20-26. Serial repeat sampling to obtain a detailed PK curve was not performed to obtain this AUC. Subjects could provide samples during these days at times convenient to them and PK software accounted for the time between when the drug was dosed versus when the sample was drawn.

Time frame: post-randomization (4 months)

LNG AUC

Baseline measurements of levonorgestrel AUC (on Aviane). Area under the curve at baseline for levonorgestrel. AUC was calculated from time zero to 168 hours and extrapolated to infinity from serial repeat sampling (0,0.5,1.1.5,2,3,4,6,8,12 hours and then single samples daily for 4 days between Cycles 1 and 2.

Time frame: baseline (2 months)

EE Steady State Baseline

Steady state levels of ethinyl estradiol (EE) at baseline (2 months)

Time frame: Baseline (2 months)

EE Steady State After Randomization

Steady state levels of ethinyl estradiol (EE) post- randomization

Time frame: Post-randomiziation 4 months

Data from ClinicalTrials.gov

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