Trial reportFertility and sterility2019
Impact of elagolix treatment on fatigue experienced by women with moderate to severe pain associated with endometriosis.
Trial report in Fertility and sterility, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 30 citations in OpenAlex.
- Endometriosis as a Systemic and Complex Disease: Toward Phenotype-Based Classification and Personalized Therapy.International journal of molecular sciences · 2026Review
- Oral Gonadotropin-Releasing Hormone Antagonists in the Treatment of Endometriosis: Advances in Research.Journal of clinical medicine research · 2025Review
- Perceived effectiveness of endometriosis therapies on fatigue: an international survey.Reproduction & fertility · 2025Article
- Hormonal and complimentary treatments for endometriosis: a narrative review.Gynecology and pelvic medicine · 2025Review
- Development and Application of a Physiologically Based Pharmacokinetic Model for Elagolix in the Adult and Adolescent Population.Clinical pharmacokinetics · 2024Article
- Mindfulness intervention effect on endometriosis-related pain dimensions and its mediator role on stress and vitality: a path analysis approach.Archives of women's mental health · 2024Article
- Hormonal treatments for endometriosis: The endocrine background.Reviews in endocrine & metabolic disorders · 2022Review
- Patient-Reported Outcome Measures in Endometriosis.Journal of clinical medicine · 2021Review
- Elagolix in the treatment of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.Expert review of clinical pharmacology · 2021Review
- A Clinician's Guide to the Treatment of Endometriosis with Elagolix.Journal of women's health (2002) · 2021Review
- Psychometric assessment of the PROMIS Fatigue Short Form 6a in women with moderate-to-severe endometriosis-associated pain.Journal of patient-reported outcomes · 2020Article
- Health-Related Quality of Life Improvements in Patients With Endometriosis Treated With Elagolix.Obstetrics and gynecology · 2020Article
- Contribution of Chronic Fatigue to Psychosocial Status and Quality of Life in Spanish Women Diagnosed with Endometriosis.International journal of environmental research and public health · 2020Article
- Chronic Fatigue, Physical Impairments and Quality of Life in Women with Endometriosis: A Case-Control Study.International journal of environmental research and public health · 2020Article
- Patients' perspectives of endometriosis-related fatigue: qualitative interviews.Journal of patient-reported outcomes · 2020Article
- Article
- Elagolix in the treatment of endometriosis: impact beyond pain symptoms.Therapeutic advances in reproductive healthReview
Corrections and comments
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Authors and funding
5 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the efficacy of elagolix, an oral GnRH antagonist, for the reduction of fatigue in women with moderate or severe endometriosis-associated pain.
designRandomized, double-blind, multicenter, placebo-controlled phase III trial.
settingClinics. PATIENT(S): A total of 860 women treated with elagolix or placebo. INTERVENTION(S): Women received either elagolix at 150 mg daily (QD) orally, elagolix at 200 mg twice daily (BID) orally, or placebo. MAIN OUTCOME MEASURE(S): Change from baseline to month 1, 3, and 6 visits, in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 6a questionnaire T-scores. RESULTS(S): At baseline, 54%-74% of women with moderate to severe pain associated with endometriosis reported having fatigue-related issues "quite a bit" or "very much," depending on the question asked. Fatigue extent was reduced to 29%-43% and 14%-29% for women treated with elagolix at 150 mg QD and 200 mg BID, respectively, at 6 months, compared with 35%-50% with placebo. The resultant decrease in fatigue T-scores was significant after elagolix treatment compared with placebo at 6 months, with changes of -2.21 and -5.90 with elagolix at 150 mg QD and 200 mg BID, respectively. Significant reduction in fatigue scores were observed among patients reporting clinically meaningful response "reduction" in dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia (-7.31, -6.62, and -4.31, respectively) compared with nonresponders. CONCLUSION(S): In women with moderate to severe endometriosis related pain, elagolix significantly reduces fatigue levels.
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