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Oral Contraceptives and Body Mass Index

Primary Purpose

Body Weight, Contraceptive Usage

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
All participants (Aviane)
Portia
Aviane
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Body Weight focused on measuring Obesity, Body weight, Oral contraception, Efficacy

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Oregon Health and Science University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Active Comparator

Arm Label

All participants

Aviane and Portia

Aviane & Aviane

Arm Description

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).

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

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)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
EE Steady State Baseline
Steady state levels of ethinyl estradiol (EE) at baseline (2 months)
EE Steady State After Randomization
Steady state levels of ethinyl estradiol (EE) post- randomization

Full Information

First Posted
October 27, 2009
Last Updated
November 25, 2015
Sponsor
Oregon Health and Science University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01170390
Brief Title
Oral Contraceptives and Body Mass Index
Official Title
Improving Contraceptive Effectiveness in Obese Women
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight, Contraceptive Usage
Keywords
Obesity, Body weight, Oral contraception, Efficacy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All participants
Arm Type
Other
Arm Description
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).
Arm Title
Aviane and Portia
Arm Type
Active Comparator
Arm Description
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
Arm Title
Aviane & Aviane
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
All participants (Aviane)
Other Intervention Name(s)
Levonorgestrel and Ethinyl Estradiol
Intervention Description
20 mcg EE/0.1 mg LNG cyclically
Intervention Type
Drug
Intervention Name(s)
Portia
Other Intervention Name(s)
Levonorgestrel and Ethinyl Estradiol
Intervention Description
30 mcg EE/0.15 mg LNG cyclically
Intervention Type
Drug
Intervention Name(s)
Aviane
Other Intervention Name(s)
Levonorgestrel and Ethinyl Estradiol
Intervention Description
20 mcg EE/0.1 mg LNG continuously dosed
Primary Outcome Measure Information:
Title
LNG Steady State at Baseline and Then Post-randomization
Description
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 Outcome Measure Information:
Title
LNG AUC
Description
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)
Title
LNG AUC
Description
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)
Title
EE Steady State Baseline
Description
Steady state levels of ethinyl estradiol (EE) at baseline (2 months)
Time Frame
Baseline (2 months)
Title
EE Steady State After Randomization
Description
Steady state levels of ethinyl estradiol (EE) post- randomization
Time Frame
Post-randomiziation 4 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Edelman, MD, MPH
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25070547
Citation
Edelman AB, Cherala G, Munar MY, McInnis M, Stanczyk FZ, Jensen JT. Correcting oral contraceptive pharmacokinetic alterations due to obesity: a randomized controlled trial. Contraception. 2014 Nov;90(5):550-6. doi: 10.1016/j.contraception.2014.06.033. Epub 2014 Jun 27.
Results Reference
derived
Links:
URL
http://www.ohsuwomenshealth.com/research/index.html
Description
(OHSU Women's Health Research Unit)

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Oral Contraceptives and Body Mass Index

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