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Oral Contraceptive Efficacy and Body Weight

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00662454
First Posted: April 21, 2008
Last Update Posted: August 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
Oregon Clinical and Translational Research Institute
Information provided by:
Oregon Health and Science University
  Purpose
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.

Condition Intervention Phase
Contraception Body Weight Drug: ethinyl estradiol / levonorgestrel Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Oral Contraceptive Efficacy and Body Weight: Does Obesity Affect the Risk of Contraceptive Failure?

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Concentrations of circulating oral contraceptives dosed in a standard cyclic fashion in obese and normal BMI cohorts [ Time Frame: Approximately one year ]

Enrollment: 120
Study Start Date: January 2006
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: I
10 normal weight women (BMI < 25 kg/m2)
Drug: ethinyl estradiol / levonorgestrel
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.
Other Name: Alesse
Active Comparator: II
10 obese women (BMI >30 kg/m2)
Drug: ethinyl estradiol / levonorgestrel
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.
Other Name: Alesse

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662454


Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
National Institutes of Health (NIH)
Oregon Clinical and Translational Research Institute
Investigators
Principal Investigator: Alison Edelman, MD, MPH Oregon Health and Science University
  More Information

Responsible Party: Alison Edelman, MD, MPH, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00662454     History of Changes
Other Study ID Numbers: OHSU FAMPLAN 0411
NIH R03 HD053611 01
First Submitted: April 16, 2008
First Posted: April 21, 2008
Last Update Posted: August 4, 2011
Last Verified: August 2011

Keywords provided by Oregon Health and Science University:
contraceptive
efficacy
body weight

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Contraceptive Agents
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Contraceptives, Oral
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral, Combined