Trials / Completed
CompletedNCT02691494
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)
A Phase 3 Study to Evaluate the Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 378 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- Female
- Age
- 18 Years – 51 Years
- Healthy volunteers
- Not accepted
Summary
This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Elagolix | Film-coated tablets |
| DRUG | Placebo for Estradiol/Norethindrone Acetate | Placebo capsules |
| DRUG | Estradiol/Norethindrone Acetate | Commercially-available E2/NETA tablets were over-encapsulated to maintain study blinding. |
| DRUG | Placebo for Elagolix | Film-coated placebo tablets |
Timeline
- Start date
- 2016-02-03
- Primary completion
- 2018-02-14
- Completion
- 2019-01-23
- First posted
- 2016-02-25
- Last updated
- 2021-07-13
- Results posted
- 2020-06-30
Locations
105 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02691494. Inclusion in this directory is not an endorsement.