Drugs / Estradiol/Norethindrone Acetate
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT03213457 | Jul 2017 → Mar 2020 | endometriosis | AbbVie | Completed | Met primary |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2020-05-29 | AbbVie | Regulatory FDA Approves the First Oral Medication for the Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-menopausal Women abbvie.com ↗
announced that the U.S. Food and Drug Administration (FDA) approved ORIAHNN™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), with a treatment duration of up to 24 months. |
| 2018-02-21 | AbbVie | Results AbbVie Announces Positive Topline Results from Phase 3 Study Evaluating Investigational Elagolix in Women with Uterine Fibroids abbvie.com ↗
The study also met all ranked secondary endpoints (p<0.001) at month six. |
| 2017-04-07 | AbbVie | Results AbbVie Announces Positive Phase 2b Data Demonstrating Investigational Medicine Elagolix Significantly Reduced Heavy Menstrual Bleeding in Women with Uterine Fibroids abbvie.com ↗
The data demonstrated that elagolix, with and without add-back therapy, met the primary efficacy endpoint of reduced heavy menstrual bleeding as compared to placebo (p<0.001). |
All press releases naming this drug 3 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Estradiol/Norethindrone Acetate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03213457 ↗ |