Trial reportObstetrics and gynecology2018
Ulipristal Acetate for Treatment of Symptomatic 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 NCT02147197 (A Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas), which is not on this map. Cited by 22 papers.
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 Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas
Who cites it
22 citing papers in PubMed.
- Health-Related Quality of Life With Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial.Obstetrics and gynecology · 2019Trial
- 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
- Mechanical Stiffness Influences the Response of Human Uterine Fibroid Cells to Hormonal Treatments.Reproductive sciences (Thousand Oaks, Calif.) · 2026Article
- Progesterone signaling in uterine fibroids: Molecular mechanisms and therapeutic opportunities.Life sciences · 2025Review
- Investigating the Impact of Benign Indication Hysterectomy on Pelvic Floor Symptoms and Sexual Function: A Prospective Study Integrating Pelvic Floor Ultrasonography and Surface Electromyography Test.Women's health reports (New Rochelle, N.Y.) · 2025Article
- Hepatic Safety Considerations in the Use of Ulipristal Acetate for Symptomatic Uterine Fibroids.Therapeutics and clinical risk management · 2025Review
- The effect of ulipristal acetate on tumor necrosis factor α, insulin-like growth factor 1, and plasminogen activator inhibitor-1 serum levels in patients with symptomatic uterine fibroids.Archives of medical science : AMS · 2024Article
- Review
- Cyclic processes in the uterine tubes, endometrium, myometrium, and cervix: pathways and perturbations.Molecular human reproduction · 2023Review
- Progesterone Signaling and Uterine Fibroid Pathogenesis; Molecular Mechanisms and Potential Therapeutics.Cells · 2023Review
- Epigenomic and enhancer dysregulation in uterine leiomyomas.Human reproduction update · 2022Review
- Uterine Fibroids (Leiomyomata) and Heavy Menstrual Bleeding.Frontiers in reproductive health · 2022Review
- Safety and efficacy of two repeated cycles of ulipristal acetate in the management of symptomatic uterine fibroid among Indian women.Przeglad menopauzalny = Menopause review · 2021Article
- Risk-efficacy balance of ulipristal acetate compared to surgical alternatives.British journal of clinical pharmacology · 2021Review
- Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids.American journal of obstetrics and gynecology · 2021Article
- Selective Progesterone Receptor Modulators-Mechanisms and Therapeutic Utility.Endocrine reviews · 2020Review
- 90 YEARS OF PROGESTERONE: Selective progesterone receptor modulators in gynaecological therapies.Journal of molecular endocrinology · 2020Review
- The Selective Progesterone Receptor Modulator Ulipristal Acetate Inhibits the Activity of the Glucocorticoid Receptor.The Journal of clinical endocrinology and metabolism · 2020Article
- Predictive Factors of Response to Selective Progesterone Receptor Modulator (Ulipristal Acetate) in the Pharmacological Treatment of Uterine Fibroids.International journal of environmental research and public health · 2020Article
- Psychometric validation of the 1-month recall Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFS-QOL).Journal of patient-reported outcomes · 2019Article
Corrections and comments
- Commented on by
- Commented on byIn Reply.2018
Authors and funding
7 authors.
Funding
Abstract
objectiveTo assess efficacy and tolerability of ulipristal acetate, a selective progesterone receptor modulator, for treatment of symptomatic uterine leiomyomas.
methodsThis phase 3, double-blind, placebo-controlled study enrolled premenopausal women (aged 18-50 years) with abnormal uterine bleeding, one or more discrete leiomyomas, and uterine size 20 weeks of gestation or less. Patients were randomized 1:1:1 to 5 mg ulipristal, 10 mg ulipristal, or placebo once daily for 12 weeks followed by 12-week drug-free follow-up. Coprimary endpoints were rate of and time to amenorrhea, defined as no bleeding for the last 35 consecutive days of treatment. Secondary endpoints included rates of amenorrhea from day 11 and change from baseline to endpoint in the Revised Activities subscale of the Uterine Fibroid Symptom and Quality of Life questionnaire, which includes questions pertaining to physical and social activities. Safety assessments included adverse event monitoring and endometrial biopsies. A sample size of 150 was planned to compare separately each dose of ulipristal with placebo.
resultsFrom March 2014 to March 2016, 157 patients were randomized. Demographics were similar across treatment groups. Amenorrhea was achieved by 25 of 53 (47.2% [97.5% CI 31.6-63.2]) and 28 of 48 (58.3% [97.5% CI 41.2-74.1]) patients treated with 5 mg and 10 mg ulipristal, respectively, compared with 1 of 56 (1.8% [97.5% CI 0.0-10.9]) placebo-treated patients (both P<.001). Time to amenorrhea was shorter for both ulipristal doses compared with placebo (P<.001), and both doses of ulipristal resulted in improved quality of life compared with placebo (P<.001). Common adverse events (5% or greater in either ulipristal group during treatment) were hypertension, elevated blood creatinine phosphokinase, and hot flushes. Serious adverse events occurred in four patients, but none was considered related to treatment. Endometrial biopsies were benign.
conclusionUlipristal at 5 mg and 10 mg were well tolerated and superior to placebo in rate of and time to amenorrhea in women with symptomatic uterine leiomyomas. CLINICAL
trial registrationClinicaltrials.gov number, NCT02147197.
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