NCT01817530 is a Phase 2 clinical trial of Elagolix in Heavy Uterine Bleeding, sponsored by AbbVie.

Who is sponsoring NCT01817530?

NCT01817530 is sponsored by AbbVie.

What drugs are being tested in NCT01817530?

Interventions in NCT01817530: Elagolix placebo, Elagolix, 0.5 mg estradiol / 0.1 mg norethindrone acetate, 1 mg estradiol / 0.5 mg norethindrone acetate, E2/NETA placebo.

What condition does NCT01817530 study?

NCT01817530 studies Heavy Uterine Bleeding, Uterine Fibroids.

Is NCT01817530 still recruiting?

NCT01817530 is currently completed. Last updated 7 July 2020.

Are results published for NCT01817530?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-07-07 · How we verify

NCT01817530

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Completed Phase 2 Results posted Last updated 7 July 2020

What this trial tests

Phase 2 trial testing Elagolix placebo in Heavy Uterine Bleeding in 571 participants. Completed in 1 December 2015.

Timeline

8 April 2013

Primary endpoint
1 June 2015

1 December 2015

Quick facts

Lead sponsor	AbbVie
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	571
Start date	8 April 2013
Primary completion	1 June 2015
Estimated completion	1 December 2015

Drugs / interventions tested

Elagolix placebo — full drug profile →
Elagolix (ELAGOLIX) — full drug profile →
0.5 mg estradiol / 0.1 mg norethindrone acetate — full drug profile →
1 mg estradiol / 0.5 mg norethindrone acetate — full drug profile →
E2/NETA placebo — full drug profile →

Conditions studied

Heavy Uterine Bleeding — all drugs for Heavy Uterine Bleeding →
Uterine Fibroids — all drugs for Uterine Fibroids →

Sponsor

AbbVie — full company profile →

Who can join

Adults 18 to 51, female only, with Heavy Uterine Bleeding or Uterine Fibroids. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month
Time frame: Baseline, Final Month (last 28 days of treatment)
The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL Volume of \< 80 mL at the Final Month and a ≥50% Reduction in MBL Volume from Baseline to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.

Sponsor's own description

This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Elagolix: First Global Approval.
Lamb YN. · · 2018 · cited 53× · PMID 30194661 · DOI 10.1007/s40265-018-0977-4
Elagolix Alone or With Add-Back Therapy in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas: A Randomized Controlled Trial.
Carr BR, Stewart EA, Archer DF, Al-Hendy A, et al · · 2018 · cited 52× · PMID 30303923 · DOI 10.1097/aog.0000000000002933
Elagolix in the treatment of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Ali M, A R S, Al Hendy A. · · 2021 · cited 20× · PMID 33682578 · DOI 10.1080/17512433.2021.1900726
Clinical Utility Of Elagolix As An Oral Treatment For Women With Uterine Fibroids: A Short Report On The Emerging Efficacy Data.
Neri M, Melis GB, Giancane E, Vallerino V, et al · · 2019 · cited 9× · PMID 31695514 · DOI 10.2147/ijwh.s185023
Efficacy of GnRH antagonists in the treatment of uterine fibroids: a meta-analysis.
Sánchez Martín MJ, Huerga López C, Cristóbal García I, Cristóbal Quevedo I. · · 2025 · cited 4× · PMID 39821450 · DOI 10.1007/s00404-025-07932-9
A systematic review and meta-analysis comparing the use of elagolix therapy alone or in combination with add-back therapy to treat women with uterine fibroid associated heavy menstrual bleeding.
Wang X, Li J, Liu Y, Zheng Y, et al · · 2025 · cited 1× · PMID 39958902 · DOI 10.21037/gs-24-386

Verify or expand the search:

Other trials of Elagolix

Trials testing the same drug.

NCT07532876 — Comparison of Elagolix and OCPs in Reducing Endometriosis Associated Pelvic Pain · Phase 4 · enrolling by invitation
NCT06076486 — A Clinical Trial to Evaluate Efficacy and Safety of Elagolix Tablets in Women With Moderate or Severe Endometriosis-asso · Phase 3 · completed
NCT03746535 — Cardiovascular Disease Risk in Women With Endometriosis · EARLY_PHASE1 · recruiting
NCT04039204 — Elagolix for Fertility Enhancement Clinical Trial · Phase 2 · completed
NCT05038878 — An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal Women · Phase 4 · terminated

Other AbbVie trials

Trials by the same sponsor.

NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants · Phase 1 · completed
NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W · Phase 3 · withdrawn
NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult · Phase 1 · completed
NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China · completed
NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01817530 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 7 July 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01817530.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing