CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,361 enrolled
Drug / intervention
91-day Levonorgestrel Oral Contraceptive +1 moredrug
Likely dose
91-day Levonorgestrel Oral Contraceptive 0.03 mgfrom 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.

Search/NCT00924560
NCT00924560Phase 2Completed
CompareCT.gov

A Multicenter, Open-Label, Randomized, Controlled Study to Compare the Effects on Bone Mineral Density of DR-105 and a 28-Day Cycle Oral Contraceptive Regimen in Healthy, Postmenarchal, Adolescent Females

Duramed Research·interventional·Posted Jun 19, 2009·Updated Oct 22, 2014

In Brief

A Phase 2 clinical trial evaluating 91-day Levonorgestrel Oral Contraceptive and 28-day Levonorgestrel Oral Contraceptive for Bone Mineral Density. Completed, enrolled 1,361 participants across 46 sites.

Detailed Summary

This study is being conducted to compare the effects of a 91-day oral contraceptive (OC) to a 28-day OC regimen on bone mineral density (BMD) in adolescent females.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBone Mineral Density
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 19, 2009
Enrollment StartJun 1, 2009
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 17.0 years ago

Interventions

91-day Levonorgestrel Oral Contraceptivedrug

Levonorgestrel/ethinyl estradiol 0.15/0.03 mg and ethinyl estradiol 0.01 mg tablet. Take 1 tablet daily

28-day Levonorgestrel Oral Contraceptivedrug

Levonorgestrel/ethinyl estradiol 0.10/0.02 mg tablet and placebo. Take 1 tablet daily