Trial reportObstetrics and gynecology2020
Elagolix Treatment for Up to 12 Months in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas.
Trial report in Obstetrics and gynecology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02925494 (Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids), which is not on this map. Cited by 20 papers, 1 of them a synthesis 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.
Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it, 66 citations in OpenAlex.
- Elagolix treatment in women with heavy menstrual bleeding associated with uterine fibroid: a systematic review and meta-analysis.BMC women's health · 2022Pooled it
- Elinzanetant (NT-814), a Neurokinin 1,3 Receptor Antagonist, Reduces Estradiol and Progesterone in Healthy Women.The Journal of clinical endocrinology and metabolism · 2021Trial
- 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
- 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
- Kisspeptin and neurokinin B: roles in reproductive health.Physiological reviews · 2025Review
- Two-year follow-up study (PRIMROSE 3) to assess bone mineral density in subjects with uterine fibroids completing the PRIMROSE 1 and PRIMROSE 2 linzagolix trials.Human reproduction open · 2025Article
- Tailoring the Diagnostic Pathway for Medical and Surgical Treatment of Uterine Fibroids: A Narrative Review.Diagnostics (Basel, Switzerland) · 2024Review
- The Emerging Therapeutic Potential of Kisspeptin and Neurokinin B.Endocrine reviews · 2024Review
- 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
- Invited review: Translating kisspeptin and neurokinin B biology into new therapies for reproductive health.Journal of neuroendocrinology · 2022Review
- Current approaches to overcome the side effects of GnRH analogs in the treatment of patients with uterine fibroids.Expert opinion on drug safety · 2022Review
- An evaluation of relugolix/estradiol/norethindrone acetate for the treatment of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.Expert opinion on pharmacotherapy · 2022Article
- Uterine Fibroids (Leiomyomata) and Heavy Menstrual Bleeding.Frontiers in reproductive health · 2022Review
- What We Know about the Long-Term Risks of Hysterectomy for Benign Indication-A Systematic Review.Journal of clinical medicine · 2021Review
- Bone Mineral Density Changes Associated With Pregnancy, Lactation, and Medical Treatments in Premenopausal Women and Effects Later in Life.Journal of women's health (2002) · 2021Review
- Elagolix in the treatment of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.Expert review of clinical pharmacology · 2021Review
- Vitamins and Uterine Fibroids: Current Data on Pathophysiology and Possible Clinical Relevance.International journal of molecular sciences · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 1 institution in 1 country.
Funding
Abstract
objectiveTo investigate the safety and efficacy of elagolix, an oral gonadotropin-releasing hormone antagonist, with hormonal add-back therapy for up to 12 months in women with heavy menstrual bleeding associated with uterine leiomyomas.
methodsElaris UF-EXTEND was a phase 3 extension study that evaluated an additional 6 months (up to 12 months total) of elagolix 300 mg twice daily with hormonal add-back therapy (estradiol 1 mg and norethindrone acetate 0.5 mg once daily) in women who completed an initial 6 months of the same treatment in one of two preceding phase 3 studies. The primary endpoint was the percentage of women with both less than 80 mL menstrual blood loss during final month and a 50% or greater reduction in menstrual blood loss from baseline to final month. Safety evaluations included adverse events and bone mineral density changes. The planned sample size of UF-EXTEND was based on estimated rollover and discontinuation rates in the two preceding studies.
resultsFrom September 2016 to March 2019, 433 women were enrolled in UF-EXTEND. Of these women, 218 received up to 12 months of elagolix with add-back therapy; the mean±SD age of this group was 42.4±5.4 years and 67.3% were black. The percentage of women who met the primary endpoint in this elagolix with add-back group was 87.9% (95% CI [83.4-92.3]). The most frequently reported adverse events with up to 12 months of elagolix plus add-back therapy were hot flush (6.9%), night sweats (3.2%), headache (5.5%), and nausea (4.1%). Mean percent decreases in bone mineral density from baseline to extension month 6 were significantly less with elagolix plus add-back therapy than with elagolix alone {between-group difference in lumbar spine: -3.3 (95% CI [-4.1 to -2.5])}.
conclusionUp to 12 months of elagolix with add-back therapy provided sustained reduction in menstrual blood loss in women with uterine leiomyomas, with the addition of add-back therapy attenuating the hypoestrogenic effects of elagolix alone. No new or unexpected safety concerns were associated with an additional 6 months of elagolix with addback therapy. CLINICAL
trial registrationClinicalTrials.gov, NCT02925494. FUNDING SOURCE: AbbVie Inc funded this study.
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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.