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Completed

NCT Number: NCT01170390

Oral Contraceptives and Body Mass Index

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.

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Key information

Conditions

Body Weight Behavior Contraception Behavior Contraceptive Usage Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Reproductive Behavior Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

All participants (Aviane)

Drug

20 mcg EE/0.1 mg LNG cyclically

Other names: Levonorgestrel and Ethinyl Estradiol

Portia

Drug

30 mcg EE/0.15 mg LNG cyclically

Other names: Levonorgestrel and Ethinyl Estradiol

Aviane

Drug

20 mcg EE/0.1 mg LNG continuously dosed

Other names: Levonorgestrel and Ethinyl Estradiol

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. EE Steady State Baseline

    Time frame: Baseline (2 months)

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

  4. EE Steady State After Randomization

    Time frame: Post-randomiziation 4 months

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

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

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

Registry information

Official study title

Improving Contraceptive Effectiveness in Obese Women

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 27, 2010
Registry last updated
Dec 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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