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Completed

NCT Number: NCT00662454

Oral Contraceptive Efficacy and Body Weight

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

ethinyl estradiol / levonorgestrel

Drug

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 names: Alesse

Primary outcomes

  1. Concentrations of circulating oral contraceptives dosed in a standard cyclic fashion in obese and normal BMI cohorts

    Time frame: Approximately one year

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Institutes of Health (NIH)
  • Oregon Clinical and Translational Research Institute

Registry information

Official study title

Oral Contraceptive Efficacy and Body Weight: Does Obesity Affect the Risk of Contraceptive Failure?

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Apr 21, 2008
Registry last updated
Sep 16, 2020

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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