Trial reportFertility and sterility2011
Efficacy and tolerability of CDB-2914 treatment for symptomatic uterine fibroids: a randomized, double-blind, placebo-controlled, phase IIb study.
Trial report in Fertility and sterility, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 35 papers, 2 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.
Evaluation of Whether the Selective Progesterone Receptor Modulator CDB-2914 Can Shrink Leiomyomata
Pilot Study on the Pre-operative Use of Ulipristal on Fibroid in Chinese Population
Who cites it
35 citing papers in PubMed, 2 syntheses or guidelines pooled it, 123 citations in OpenAlex.
- Selective progesterone receptor modulators (SPRMs) for uterine fibroids.The Cochrane database of systematic reviews · 2017Pooled it
- Medical Therapies for Uterine Fibroids - A Systematic Review and Network Meta-Analysis of Randomised Controlled Trials.PloS one · 2016Pooled it
- NAV3, a Tumor Suppressor Gene, Is Decreased in Uterine Leiomyoma Tissue and Cells.Reproductive sciences (Thousand Oaks, Calif.) · 2020Trial
- Ulipristal Acetate for Unscheduled Bleeding in Etonogestrel Implant Users: A Randomized Controlled Trial.Obstetrics and gynecology · 2018Trial
- Ulipristal Acetate for Treatment of Symptomatic Uterine Leiomyomas: A Randomized Controlled Trial.Obstetrics and gynecology · 2018Trial
- Ulipristal Acetate and Extracellular Matrix Production in Human Leiomyomas In Vivo: A Laboratory Analysis of a Randomized Placebo Controlled Trial.Reproductive sciences (Thousand Oaks, Calif.) · 2018Trial
- Progesterone signaling in uterine fibroids: Molecular mechanisms and therapeutic opportunities.Life sciences · 2025Review
- Measurement of changes in uterine and fibroid volume during treatment of heavy menstrual bleeding (HMB).Human reproduction open · 2023Article
- Review
- Selective Progesterone Receptor Modulators-Mechanisms and Therapeutic Utility.Endocrine reviews · 2020Review
- A-Kinase Anchoring Protein 13 (AKAP13) Augments Progesterone Signaling in Uterine Fibroid Cells.The Journal of clinical endocrinology and metabolism · 2019Article
- Ulipristal Acetate Mediates Decreased Proteoglycan Expression Through Regulation of Nuclear Factor of Activated T-Cells (NFAT5).Reproductive sciences (Thousand Oaks, Calif.) · 2019Article
- Uterine fibroids: an update on current and emerging medical treatment options.Therapeutics and clinical risk management · 2019Review
- Discovery of Vilaprisan (BAY 1002670): A Highly Potent and Selective Progesterone Receptor Modulator Optimized for Gynecologic Therapies.ChemMedChem · 2018Article
- Current medical treatment of uterine fibroids.Obstetrics & gynecology science · 2018Review
- A Comprehensive Review of the Pharmacologic Management of Uterine Leiomyoma.BioMed research international · 2018Review
- Recent Advances in Uterine Fibroid Etiology.Seminars in reproductive medicine · 2017Review
- The Rising Phoenix-Progesterone as the Main Target of the Medical Therapy for Leiomyoma.BioMed research international · 2017Review
- Uterine fibroid management: from the present to the future.Human reproduction update · 2016Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 3 institutions in 1 country.
Funding
Abstract
objectiveTo evaluate the efficacy and tolerability of the P receptor modulator CDB-2914 (Ulipristal, CDB).
designRandomized, placebo-controlled double-blind clinical trial.
settingClinical research center. PATIENT(S): Premenopausal women with symptomatic uterine fibroids. INTERVENTION(S): Once-daily oral CDB (10 or 20 mg) or placebo (PLC) for 12 weeks (treatment 1). A second 3-month treatment with CDB (treatment 2) was offered. A computer-generated blocked randomization was used. MAIN OUTCOME MEASURE(S): Magnetic resonance imaging (MRI)-determined total fibroid volume (TFV) change was the primary outcome; amenorrhea and quality of life (QOL) were secondary end points. RESULT(S): Treatment 1 TFV increased 7% in the PLC group, but decreased 17% and 24% in the CDB10 and CDB20 groups. The TFV decreased further in treatment 2 (-11%). Amenorrhea occurred in 20/26 women taking CDB and none on PLC. Ovulation resumed after CDB. Hemoglobin improved only with CDB (11.9 ± 1.5 to 12.9 ± 1.0 g/dL) as did the Fibroid QOL Questionnaire symptom severity, energy/mood, and concern subscores, and overall QOL scores. The CDB was well tolerated, with no serious adverse events. Adverse events were unchanged during treatments. CONCLUSION(S): Administration of CDB-2914 for 3-6 months controls bleeding, reduces fibroid size, and improves QOL.
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.