Trial reportObstetrics and gynecology2018
Elagolix Alone or With Add-Back Therapy in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas: A Randomized Controlled Trial.
Trial report in Obstetrics and gynecology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01817530 (A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids), which is not on this map. Cited by 28 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Who cites it
28 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Medical treatment of fibroids: FIGO best practice guidance.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025Guideline
- Elagolix treatment in women with heavy menstrual bleeding associated with uterine fibroid: a systematic review and meta-analysis.BMC women's health · 2022Pooled it
- Progestogens or progestogen-releasing intrauterine systems for uterine fibroids (other than preoperative medical therapy).The Cochrane database of systematic reviews · 2020Pooled it
- Effect of Gonadotropin-Releasing Hormone Antagonist on Risk of Committing Child Sexual Abuse in Men With Pedophilic Disorder: A Randomized Clinical Trial.JAMA psychiatry · 2020Trial
- Safety and efficacy of vilaprisan in Japanese women with fibroids: The Phase 3 ASTEROID 8 trial.Women's health (London, England)Trial
- Efficacy and Safety of Vilaprisan in the Treatment of Uterine Fibroids: Data from ASTEROID 5, a Phase 3 Multicenter Randomized Controlled Trial.Journal of clinical medicine · 2026Article
- Safety of 48 months of elagolix with add-back therapy for endometriosis-associated pain.AJOG global reports · 2026Article
- Bone mineral density with elagolix plus add-back therapy in women with heavy menstrual bleeding and uterine fibroids: open-label and post-treatment results of a 60-month phase 3 trial.AJOG global reports · 2025Article
- Nutrition and Uterine Fibroids: Clinical Impact and Emerging Therapeutic Perspectives.Journal of clinical medicine · 2025Review
- Oral Gonadotropin-Releasing Hormone Antagonists in the Treatment of Endometriosis: Advances in Research.Journal of clinical medicine research · 2025Review
- Article
- Article
- Development and Application of a Physiologically Based Pharmacokinetic Model for Elagolix in the Adult and Adolescent Population.Clinical pharmacokinetics · 2024Article
- Recurrence of Uterine Fibroids After Conservative Surgery or Radiological Procedures: a Narrative Review.Reproductive sciences (Thousand Oaks, Calif.) · 2024Review
- The efficacy of medical management of leiomyoma-associated heavy menstrual bleeding: a mini review.F&S reports · 2024Article
- Review
- Clinical development of the oral gonadotropin-releasing hormone antagonist elagolix.F&S reports · 2023Article
- Interdisciplinary model-informed drug development for extending duration of elagolix treatment in patients with uterine fibroids.British journal of clinical pharmacology · 2022Article
- Variation of outcome reporting in studies of interventions for heavy menstrual bleeding: a systematic review.Facts, views & vision in ObGyn · 2022Article
- A model-based analysis to guide gonadotropin-releasing hormone receptor antagonist use for management of endometriosis.British journal of clinical pharmacology · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
Abstract
objectiveTo evaluate elagolix, an oral gonadotropin-releasing hormone receptor antagonist, alone or with add-back therapy, in premenopausal women with heavy menstrual bleeding (greater than 80 mL per month) associated with uterine leiomyomas.
methodsThis double-blind, randomized, placebo-controlled, parallel-group study evaluated efficacy and safety of elagolix in cohorts 1 (300 mg twice daily) and 2 (600 mg daily) with four arms per cohort: placebo, elagolix alone, elagolix with 0.5 mg estradiol/0.1 norethindrone acetate, and elagolix with 1.0 mg estradiol/0.5 mg norethindrone acetate. A sample size of 65 per group was planned to compare elagolix with add-back to placebo on the primary end point: the percentage of women who had less than 80 mL menstrual blood loss and 50% or greater reduction in menstrual blood loss from baseline to the last 28 days of treatment. Safety assessments included changes in bone mineral density.
resultsFrom April 8, 2013, to December 8, 2015, 571 women were enrolled, 567 were randomized and treated (cohort 1=259; cohort 2=308), and 80% and 75% completed treatment, respectively. Participants had a mean±SD age of 43±5 years (cohort 2, 42±5 years), and 70% were black (cohort 2, 74%). Primary end point responder rates in cohort 1 (cohort 2) were 92% (90%) for elagolix alone, 85% (73%) for elagolix with 0.5 mg estradiol/0.1 mg norethindrone acetate, 79% (82%) for elagolix with 1.0 mg estradiol/0.5 mg norethindrone acetate, and 27% (32%) for placebo (all P<.001 vs placebo). Elagolix groups had significant decreases compared with placebo in lumbar spine bone mineral density, which was attenuated by adding 1.0 mg estradiol/0.5 mg norethindrone acetate.
conclusionElagolix with and without add-back significantly reduced menstrual blood loss in women with uterine leiomyomas. Add-back therapy reduced hypoestrogenic effects on bone mineral density. CLINICAL
trial registrationClinicalTrials.gov, NCT01817530; EU Clinical Trial Register, 2013-000082-37.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.