NCT00044876

Treatment of Uterine Fibroids With CDB-2914, an Experimental Selective Progesterone Receptor Antagonist

Completed Phase 2 Last updated 17 December 2019

What this trial tests

Phase 2 trial testing CDB-2914 in Leiomyoma in 56 participants. Completed in 1 October 2015.

Timeline

2 September 2002

Primary endpoint
16 June 2007

1 October 2015

Quick facts

Lead sponsor	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Primary purpose	treatment
Enrollment	56
Start date	2 September 2002
Primary completion	16 June 2007
Estimated completion	1 October 2015
Sites	1 location across United States

Drugs / interventions tested

• CDB-2914 — full drug profile →

Conditions studied

• Leiomyoma — all drugs for Leiomyoma →

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Who can join

Adults 33 to 50, female only, with Leiomyoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Uterine leiomyomata (fibroids) are a common benign tumor of the uterine muscle in premenopausal women. These tumors may cause bleeding, pelvic pain and pressure. Because fibroids grow in the presence of estrogen, medical therapies that decrease estrogen levels (like GnRH analog) cause fibroids to shrink and so may relieve symptoms. However, such medication can only be given short-term and has inconvenient side effects such as hot-flushes. Thus, many women with symptomatic fibroids choose to have them removed surgically, either individually or by removing the uterus via hysterectomy.

The study evaluates a new medical treatment for fibroids using the progesterone receptor modulator CDB-2914. A similar compound, mifepristone (Registered Trademark), reduced fibroid size when given for twelve weeks. This study will compare fibroid size, hormone levels and symptoms before and during daily administration of CDB-2914 (10 or 25 mg) or placebo for 10 - 14 weeks. To do this, women will undergo MRI and a saline hysterosonogram (ultrasound with fluid) of the uterus before and at the end of the treatment; they will have blood drawn every 7 - 14 days, and will fill out a symptom calendar at home. Hysterectomy will be performed at the end of the treatment to evaluate the effects of the medication on the uterine and fibroid tissues, and to provide treatment for the study participant. Women will be randomly assigned to the treatment groups; during the treatment period neither the participants nor the investigators will know the type of treatment that a woman receives.

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Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Selective progesterone receptor modulators (SPRMs) for uterine fibroids.
   Murji A, Whitaker L, Chow TL, Sobel ML. · · 2017 · cited 42× · PMID 28444736 · DOI 10.1002/14651858.cd010770.pub2
2. Indian Hedgehog and its targets in human endometrium: menstrual cycle expression and response to CDB-2914.
   Wei Q, Levens ED, Stefansson L, Nieman LK. · · 2010 · cited 38× · PMID 20881264 · DOI 10.1210/jc.2010-0637
3. Antiprogestins in gynecological diseases.
   Goyeneche AA, Telleria CM. · · 2015 · cited 20× · PMID 25252652 · DOI 10.1530/rep-14-0416