Treatment of Uterine Fibroids With CDB-2914, an Experimental Selective Progesterone Receptor Antagonist
Condition: Leiomyoma
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 2

Summary: 
      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.

      ...
    

Detailed 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.
    

Intervention name(s): CDB-2914
Intervention type(s): Drug
Intervention MeSH terms: Ulipristal acetate
Primary purpose: Treatment
Keywords: Endometrium; Progesterone; Estrogen; Leiomyoma; Uterine Leiomyoma; Uterine Fibroids; Fibroids