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Oral Contraceptives and Body Mass Index

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Alison Edelman, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01170390
First received: October 27, 2009
Last updated: June 1, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Body Weight
Contraceptive Usage
 Drug: Alesse
Drug: Portia
Drug: Midazolam
Drug: Tolbutamide
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Improving Contraceptive Effectiveness in Obese Women

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • To determine if alternative dosing regimens result in improved pharmacokinetic parameters and ovarian suppression and similar safety biomarkers in obese women. [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To confirm obesity-related differences in the pharmacokinetics of orally-dosed combined hormonal contraceptives. [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: September 2009
Study Completion Date: December 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Study Arm #1
A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). 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: Alesse
20 mcg EE/0.1 mg LNG
Other Name: Levonorgestrel and Ethinyl Estradiol
Drug: Midazolam
2 mg
Other Name: Versed
Drug: Tolbutamide
125 mg
Other Name: Orinase
Active Comparator: Study Arm #2
A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). 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: Alesse
20 mcg EE/0.1 mg LNG
Other Name: Levonorgestrel and Ethinyl Estradiol
Drug: Portia
30 mcg EE/0.15 mg LNG
Other Name: Levonorgestrel and Ethinyl Estradiol
Drug: Midazolam
2 mg
Other Name: Versed
Drug: Tolbutamide
125 mg
Other Name: Orinase

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170390

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Alison Edelman, MD, MPH Oregon Health and Science University
  More Information

Additional Information:
(OHSU Women's Health Research Unit)  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Alison Edelman, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01170390     History of Changes
Other Study ID Numbers: OHSU FAMPLAN 5382, R01HD061582
Study First Received: October 27, 2009
Last Updated: June 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Obesity
Body weight
Oral contraception
Efficacy

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Midazolam
Estradiol
Ethinyl Estradiol
Tolbutamide
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Adjuvants, Anesthesia
 Central Nervous System Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Estrogens
Hormones

ClinicalTrials.gov processed this record on May 16, 2013