Trials / Completed
CompletedNCT02925494
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 433 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- Female
- Age
- 18 Years – 51 Years
- Healthy volunteers
- Not accepted
Summary
This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Estradiol/Norethindrone Acetate | capsules |
| DRUG | Elagolix | film-coated tablets |
Timeline
- Start date
- 2016-09-14
- Primary completion
- 2018-05-07
- Completion
- 2019-03-22
- First posted
- 2016-10-06
- Last updated
- 2021-07-13
- Results posted
- 2020-06-30
Locations
124 sites across 3 countries: United States, Canada, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02925494. Inclusion in this directory is not an endorsement.