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Sponsors and Collaborators: |
Columbia University National Institutes of Health (NIH) |
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Information provided by: | Columbia University |
ClinicalTrials.gov Identifier: | NCT00827632 |
There is a large gap between lowest expected failure rates of about 1.5% and typical use failure rates of about 7% per year. This gap may be due to incorrect use or to decreased OC effectiveness in population subgroups. Recent reports suggest greater OC failure among heavier women, particularly those using the lowest doses. The prevalence of obesity in the US population has recently increased to about 23% in women aged 2029, peak years for OC use. OC physiology and effectiveness have not been evaluated in obese women. We propose a double blind randomized clinical trial to include normal weight and obese women who have normal ovulatory function at baseline; we will randomize women to 2 widely used OCs and evaluate ovarian follicle development and circulating progesterone to assess ovarian suppression during OC use.
Condition | Intervention | Phase |
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Ovarian Suppression |
Drug: Drug dosage: Portia and Lessina |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Oral Contraception and Ovarian Suppression in Women With Different Weights |
Enrollment: | 226 |
Study Start Date: | July 2006 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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BMI group: Experimental
Participants are sorted into normal BMI (19-24.9) or obese BMI (30-39.9) groups.
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Drug: Drug dosage: Portia and Lessina
Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, USP .15 mg/.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP .1 mg/.02 mg) for 3 months use.
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Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Columbia University ( Carolyn Westhoff, M.D. ) |
Study ID Numbers: | AAAB4823, RO1 HD04578601A2 |
Study First Received: | January 21, 2009 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00827632 History of Changes |
Health Authority: | United States: Institutional Review Board |
Ovarian Suppression Oral Contraceptives Obese and Normal BMI |
Body Weight Obesity Contraceptive Agents Levonorgestrel Estradiol 3-benzoate Contraceptives, Oral |
Estradiol valerate Ethinyl Estradiol Estradiol 17 beta-cypionate Polyestradiol phosphate Estradiol |