At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 53 enrolled
Drug / intervention
Norethindrone acetate + estrogens +1 moredrug
Likely dose
Norethindrone acetate + estrogens 5 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.
The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial
In Brief
A Phase 2 clinical trial evaluating Norethindrone acetate + estrogens and norethindrone acetate + placebo for Endometriosis. Completed, enrolled 53 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether a regimen of norethindrone acetate + placebo or norethindrone acetate + conjugated estrogens is superior in maintaining skeletal health and quality of life in adolescents treated with a GnRH agonist for endometriosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometriosis
CountriesUnited States
CollaboratorsBrigham and Women's Hospital
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2007
Enrollment StartAug 2007
Primary CompletionOct 2013
Study CompletionJan 2015
TodayJul 2026
First PostedMay 17, 2007
Enrollment StartAug 1, 2007
Primary CompletionOct 1, 2013
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 19.1 years ago
Interventions
Norethindrone acetate + estrogensdrug
Norethindrone acetate 5 mg by mouth daily + Conjugated equine estrogens 0.625 mg by mouth daily
norethindrone acetate + placebodrug
norethindrone acetate 5 mg by mouth daily + Placebo capsule 1 pill by mouth daily