At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 47 enrolled
Drug / intervention
Ortho Cyclen®drug
Likely dose
Ortho Cyclen® 35 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women
In Brief
A Phase 4 clinical trial evaluating Ortho Cyclen® for Insulin Sensitivity and 2 related conditions. Completed, enrolled 47 participants across 1 site.
Detailed Summary
Birth control pills are the most commonly used method of birth control. The purpose of this research study is to examine whether birth control pills change heart disease risk and how the body handles blood sugar when given to different women.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAmerican Heart Association
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2011
First PostedNov 2011
Primary CompletionMay 2014
TodayJul 2026
First PostedNov 21, 2011
Enrollment StartNov 1, 2011
Primary CompletionMay 28, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 14.6 years ago
Interventions
Ortho Cyclen®drug
Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) will be taken as one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill.