Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Trial Profile

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 of Trial: Phase III

Latest Information Update: 03 Jun 2022

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Elagolix (Primary) ; Estradiol/norethisterone
  • Indications Uterine leiomyoma
  • Focus Registrational; Therapeutic Use
  • Acronyms ELARIS UF-II; Replicate Study
  • Sponsors AbbVie
  • Most Recent Events

    • 01 May 2022 Results of pooled post hoc analysis assessed mean changes from baseline in menstrual blood loss ad adverse event from two study (ELARIS UF-1 and 2) published in the Journal of Women's Health.
    • 20 Jul 2020 Results of pooled analysis of two studies (ELARIS UF-1 & 2) assessing safety and efficacy of elagolix (300mg BID) with add-back therapy (1 mg estradiol/0.5mg norethindrone acetate [E2/NETA]) in reducing heavy menstrual bleeding associated with uterine fibroids in various subgroups of women over 6-months of treatment, published in the American Journal of Obstetrics and Gynecology.
    • 29 May 2020 According to an AbbVie media release, Ayman Al-Hendy, is the investigator for the ELARIS UF-2 clinical trials.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top