A Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas
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Purpose
The first indication of hysterectomies in France are uterine leiomyomas. When they are symptomatic leiomyomas are particularly responsables of an increase of menstruations duration and volume. Echography is the reference exam for the diagnosis. It exists two treatments ways:-firstly progestatives and antifibrinolytics for the treatment of hemorragic symptoms, -secondly LH-RH analogs for the treatment of leiomyomas volume and hemorragic symptoms but just used for a small period because of the risk of osteoporosis.
Different studies with different doses of mifepristone were released. The authors observe a decrease of leiomyomas volume. Based on this experience the present placebo controlled study has for objectives:-to confirm the efficacy of 10 mg oral mifepristone during 24 weeks in the volume decrease and in symptoms of leiomyomas, - to assess the safety of the treatment. The aim is to avoid or delay the hysterectomy of non menopausal patients. During the study patients will be evaluated with biological exams, clinical exams, echographies, medical interrogations and their diary cards.
| Condition | Intervention | Phase |
|---|---|---|
|
Leiomyoma |
Drug: mifepristone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Placebo Controlled Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas |
- To determine the efficacy of 10 mg oral mifepristone during 24 weeks in the volume decrease of symptomatic uterine leiomymomas
- -To determine the efficacy of 10 mg oral mifepristone in symptoms of non menopausal patients with uterine leiomyomas
- -To determine the safety of oral mifepristone at the dose of 10 mg per day during 24 weeks
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2004 |
| Study Completion Date: | February 2009 |
Eligibility| Ages Eligible for Study: | 25 Years to 49 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients who are willing and able to participate in the study
- patients from whom written informed consent has been obtained
- patients who contribute to the National Insurance Scheme
- patients with an age between 25 and 49 years old
- non menopausal patients
- patients who use a non hormonal contraception
- patients with one or several , interstitial or subserous, uterine leiomyomas
- echographic diameter of leiomyomas must be equal or higher than 30 mm
- leiomyomas must be symptomatic
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00219778 History of Changes |
| Other Study ID Numbers: | RUFIB |
| Study First Received: | September 16, 2005 |
| Last Updated: | March 2, 2010 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Leiomyoma Myofibroma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases Mifepristone Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents |
Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptives, Postcoital, Synthetic Contraceptives, Postcoital Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Luteolytic Agents Menstruation-Inducing Agents Abortifacient Agents, Steroidal Abortifacient Agents |
ClinicalTrials.gov processed this record on May 19, 2013