A Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas - Full Text View

Sponsor:	Poitiers University Hospital
Information provided by:	Poitiers University Hospital
ClinicalTrials.gov Identifier:	NCT00219778

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

Further study details as provided by Poitiers University Hospital:

Primary Outcome Measures:

To determine the efficacy of 10 mg oral mifepristone during 24 weeks in the volume decrease of symptomatic uterine leiomymomas

Secondary Outcome Measures:

-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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219778

Locations

France
Poitiers University Hospital
Poitiers, France, 86000

Sponsors and Collaborators

Poitiers University Hospital

Investigators

Principal Investigator:

Guillaume Magnin, Professor

Poitiers University Hospital

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 - French Health Products Safety Agency

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 21, 2012