Status:
COMPLETED
Oral Contraceptive Efficacy and Body Weight
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
National Institutes of Health (NIH)
Oregon Clinical and Translational Research Institute
Conditions:
Contraception
Body Weight
Eligibility:
FEMALE
18-35 years
Phase:
PHASE4
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. Th...
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 ide...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00662454
Start Date
January 1 2006
End Date
May 1 2006
Last Update
September 16 2020
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239