CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 271 enrolled
Drug / intervention
Elagolix +4 moredrug
Likely dose
Estradiol/Norethindrone acetate (E2/NETA) 0.5 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.

Search/NCT01441635
NCT01441635Phase 2Completed
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Phase 2a Proof Of Concept Study to Evaluate the Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids

AbbVie (prior sponsor, Abbott)·interventional·Posted Sep 28, 2011·Updated Jul 13, 2021

In Brief

A Phase 2 clinical trial evaluating Elagolix, Placebo, and 3 other interventions for Heavy Uterine Bleeding and Uterine Fibroids. Completed, enrolled 271 participants.

Detailed Summary

The purpose of this proof-of-concept study is to assess the safety and effectiveness of elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to reduce fibroid volume and uterine volume in premenopausal women 20 to 49 years of age with heavy uterine bleeding.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeavy Uterine Bleeding, Uterine Fibroids
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 28, 2011
Enrollment StartSep 8, 2011
Primary CompletionNov 1, 2013
Study CompletionMay 17, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.8 years ago

Interventions

Elagolixdrug

Elagolix tablets

Placebodrug

Matching placebo tablets

Estradiol/Norethindrone acetate (E2/NETA)drug

A continuous once-daily oral tablet containing estrogen and progestin; the low-dose strength contains estradiol 0.5 mg and norethindrone acetate 0.1 mg.

Estradioldrug

1.0 mg micronized estradiol tablets administered once a day

Progesteronedrug

Progesterone 200 mg administered during the last 12 days of the 28-day menstrual cycle