Evidence map›Paper›PMID 18448745›Full record

Trial reportObstetrics and gynecology2008

CDB-2914 for uterine leiomyomata treatment: a randomized controlled trial.

Eric D Levens, Clariss Potlog-Nahari, Alicia Y Armstrong, Robert Wesley, Ahalya Premkumar, Diana L Blithe, Wendy Blocker, Lynnette K Nieman

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Obstetrics and gynecology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00290251 (Evaluation of Whether the Selective Progesterone Receptor Modulator CDB-2914 Can Shrink Leiomyomata), which is not on this map. Cited by 52 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 6 pooled it
11.7field-weighted citation impact, top 1% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT00290251 phase2completednot on this map

Evaluation of Whether the Selective Progesterone Receptor Modulator CDB-2914 Can Shrink Leiomyomata

TypeinterventionalSponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Ran2006 to 2010Enrolled72ConditionsLeiomyomaArmsulipristal acetate 20 mg, ulipristal acetate 10 mg, placebo
3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 6 syntheses or guidelines pooled it, 155 citations in OpenAlex.

  1. Preoperative medical therapy before surgery for uterine fibroids.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Pooled it
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  4. Preoperative medical therapy before surgery for uterine fibroids.The Cochrane database of systematic reviews · 2017
    Pooled it
  5. Selective progesterone receptor modulators (SPRMs) for uterine fibroids.The Cochrane database of systematic reviews · 2017
    Pooled it
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 3 countries.

Eric D LevensReproductive Biology and Medicine Branch, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland 20892, USA.
Clariss Potlog-Nahari
Alicia Y Armstrong
Robert Wesley
Ahalya Premkumar
Diana L Blithe
Wendy Blocker
Lynnette K Nieman
Health and Human Development (2HD) Research Network · CMCardinal Glennon Children’s Medical Center · USNational Institutes of Health · US

Funding

STEROID HORMONE ACTION IN FEMALE REPRODUCTIONZ01HD000637 · NICHD · EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT · PI NIEMAN, LYNNETTE K · 1994 to 2008
$2.8M
Steroid Hormone Action In Female ReproductionZIAHD000637 · NICHD · EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT · PI NIEMAN, LYNNETTE · 2009 to 2015
$2.4M
Intramural NIH HHS Z01 HD000637
6 · The paper itself

Abstract

objectiveTo evaluate whether 3-month administration of CDB-2914, a selective progesterone receptor modulator, reduces leiomyoma size and symptoms.

methodsPremenopausal women with symptomatic uterine leiomyomata were randomly assigned to CDB-2914 at 10 mg (T1) or 20 mg (T2) daily or to placebo (PLC) for 3 cycles or 90-102 days if no menses occurred. The primary outcome was leiomyoma volume change determined by magnetic resonance imaging at study entry and within 2 weeks of hysterectomy. Secondary outcomes included the proportion of amenorrhea, change in hemoglobin and hematocrit, ovulation inhibition, and quality-of-life assessment.

resultsTwenty-two patients were allocated, and 18 completed the trial. Age and body mass index were similar among groups. Leiomyoma volume was significantly reduced with CDB-2914 administration (PLC 6%; CDB-2914 -29%; P=.01), decreasing 36% and 21% in the T1 and T2 groups, respectively. During treatment, hemoglobin was unchanged, and the median estradiol was greater than 50 pg/mL in all groups. CDB-2914 eliminated menstrual bleeding and inhibited ovulation (% ovulatory cycles: CDB-2914, 20%; PLC, 83%; P=.001). CDB-2914 improved the concern scores of the uterine leiomyoma symptom quality-of-life subscale (P=.04). One CDB-2914 woman developed endometrial cystic hyperplasia without evidence of atypia. No serious adverse events were reported.

conclusionCompared with PLC, CDB-2914 significantly reduced leiomyoma volume after three cycles, or 90-102 days. CDB-2914 treatment resulted in improvements in the concern subscale of the Uterine Fibroid Symptom Quality of Life assessment. In this small study, CDB-2914 was well-tolerated without serious adverse events. Thus, there may be a role for CDB-2914 in the treatment of leiomyomata. CLINICAL

trial registrationClinicalTrials.gov,www.clinicaltrials.gov, NCT00290251 LEVEL OF EVIDENCE: I.

Indexed as

AdultFemaleHealth Status IndicatorsHematocritHumansLeiomyomaMagnetic Resonance ImagingMiddle AgedNorpregnadienesQuality of LifeTreatment OutcomeUterine NeoplasmsNorpregnadienesulipristal

Identifiers

PMID18448745
PMCPMC2742990
OpenAlexW2035366757

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.