Oral Contraceptives and Body Mass Index

November 25, 2015 updated by: Alison Edelman, Oregon Health and Science University

Improving Contraceptive Effectiveness in Obese Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: All participants
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).
Drug: All participants (Aviane)
20 mcg EE/0.1 mg LNG cyclically
Other Names:
  • Levonorgestrel and Ethinyl Estradiol
Active Comparator: Aviane and Portia
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
Drug: Portia
30 mcg EE/0.15 mg LNG cyclically
Other Names:
  • Levonorgestrel and Ethinyl Estradiol
Active Comparator: Aviane & Aviane
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)
Drug: Aviane
20 mcg EE/0.1 mg LNG continuously dosed
Other Names:
  • Levonorgestrel and Ethinyl Estradiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LNG Steady State at Baseline and Then Post-randomization
Time Frame: baseline (2 months) and post-randomization (4 months)
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).
baseline (2 months) and post-randomization (4 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LNG AUC
Time Frame: post-randomization (4 months)
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.
post-randomization (4 months)
LNG AUC
Time Frame: baseline (2 months)
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.
baseline (2 months)
EE Steady State Baseline
Time Frame: Baseline (2 months)
Steady state levels of ethinyl estradiol (EE) at baseline (2 months)
Baseline (2 months)
EE Steady State After Randomization
Time Frame: Post-randomiziation 4 months
Steady state levels of ethinyl estradiol (EE) post- randomization
Post-randomiziation 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Alison Edelman, MD, MPH, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

October 27, 2009

First Submitted That Met QC Criteria

July 26, 2010

First Posted (Estimate)

July 27, 2010

Study Record Updates

Last Update Posted (Estimate)

December 31, 2015

Last Update Submitted That Met QC Criteria

November 25, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OHSU FAMPLAN 5382
  • R01HD061582 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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