Oral Contraceptive Efficacy and Body Weight
Primary Purpose
Contraception, Body Weight
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ethinyl estradiol / levonorgestrel
ethinyl estradiol / levonorgestrel
Sponsored by

About this trial
This is an interventional diagnostic trial for Contraception focused on measuring contraceptive, efficacy, body weight
Eligibility Criteria
Inclusion Criteria:
- age 18 to 35
- single baseline hematocrit ≥ 36%
- single progesterone level of 3 ng/mL or greater during the luteal phase (days 18 to 25) in the menstrual cycle prior to treatment with OCs.
Exclusion Criteria:
- any absolute contraindications to ethinyl estradiol and levonorgestrel
- smoking
- actively seeking or involved in a weight loss program (must be weight stable)
- pregnancy, breastfeeding, or seeking pregnancy
- diagnosis of Polycystic Ovarian Syndrome
- recent (8 week) use of OC (patch or ring included), intrauterine, or implantable hormonal contraception
- DepoProvera use within six months
- current use of drugs that interfere with metabolism of sex steroids.
Sites / Locations
- Oregon Health & Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
I
II
Arm Description
10 normal weight women (BMI < 25 kg/m2)
10 obese women (BMI >30 kg/m2)
Outcomes
Primary Outcome Measures
Concentrations of circulating oral contraceptives dosed in a standard cyclic fashion in obese and normal BMI cohorts
Secondary Outcome Measures
Full Information
NCT ID
NCT00662454
First Posted
April 16, 2008
Last Updated
September 14, 2020
Sponsor
Oregon Health and Science University
Collaborators
National Institutes of Health (NIH), Oregon Clinical and Translational Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00662454
Brief Title
Oral Contraceptive Efficacy and Body Weight
Official Title
Oral Contraceptive Efficacy and Body Weight: Does Obesity Affect the Risk of Contraceptive Failure?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
National Institutes of Health (NIH), Oregon Clinical and Translational Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the blood spot validation portion of the study is to test if measuring female hormone levels in the blood is as accurate through a finger stick, as it is by a blood draw from a vein. The purpose of the feasibility study is to evaluate ovulation occurrence in two populations of oral contraceptive users: heavier and lighter women.
Detailed Description
The blood spot validation portion of the study tests the hypothesis that progesterone assays from self-collected daily blood spots are equivalent to serum samples, and that the values obtained can identify women that ovulate. After validating collection methods, enrollment will begin for the feasibility portion of the study looking at thin and heavy women on birth control pills. All women in this portion of the study will take a very-low dose birth control pill that is normally available through a doctor's office. During each month of the study, women will have their blood pressure and weight recorded, and have their blood drawn twice per week or use a finger stick kit daily at home to check for the natural hormones and brain chemicals that tells if an egg develops. During the last week of each menstrual cycle (period week), women will also have their blood drawn to measure the levels of hormone found in the birth control pill. Women will also need to report in a written diary that they have taken their birth control pill for the day.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contraception, Body Weight
Keywords
contraceptive, efficacy, body weight
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Active Comparator
Arm Description
10 normal weight women (BMI < 25 kg/m2)
Arm Title
II
Arm Type
Active Comparator
Arm Description
10 obese women (BMI >30 kg/m2)
Intervention Type
Drug
Intervention Name(s)
ethinyl estradiol / levonorgestrel
Other Intervention Name(s)
Alesse
Intervention Description
Take one tablet daily of 20 mcg ethinyl estradiol/100 mcg levonorgestrel for 21 days plus 7 days of placebo tablets, repeat for two months total duration.
Intervention Type
Drug
Intervention Name(s)
ethinyl estradiol / levonorgestrel
Other Intervention Name(s)
Alesse
Intervention Description
Take one tablet daily of 20 mcg ethinyl estradiol/100 mcg levonorgestrel for 21 days plus 7 days of placebo tablets, repeat for two months total duration.
Primary Outcome Measure Information:
Title
Concentrations of circulating oral contraceptives dosed in a standard cyclic fashion in obese and normal BMI cohorts
Time Frame
Approximately one year
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 to 35
single baseline hematocrit ≥ 36%
single progesterone level of 3 ng/mL or greater during the luteal phase (days 18 to 25) in the menstrual cycle prior to treatment with OCs.
Exclusion Criteria:
any absolute contraindications to ethinyl estradiol and levonorgestrel
smoking
actively seeking or involved in a weight loss program (must be weight stable)
pregnancy, breastfeeding, or seeking pregnancy
diagnosis of Polycystic Ovarian Syndrome
recent (8 week) use of OC (patch or ring included), intrauterine, or implantable hormonal contraception
DepoProvera use within six months
current use of drugs that interfere with metabolism of sex steroids.
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 & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.ohsuwomenshealth.com/research/index.html
Description
OHSU Women's Health Research Unit
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Oral Contraceptive Efficacy and Body Weight
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