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

Sponsored by:	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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Placebo Controlled Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas

Resource links provided by NLM:

Drug Information available for: Mifepristone

U.S. FDA Resources

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
Estimated Study Completion Date:	June 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

Contacts

Contact: Guillaume MAGNIN, Professor

(33)05-49-44-39-45

g.magnin@chu-poitiers.fr

Locations

France
Poitiers University Hospital	Recruiting
Poitiers, France, 86000
Contact: Guillaume Magnin, Professor (33)05-49-44-39-45 g.magnin@chu-pôitiers.fr
Sub-Investigator: Fabrice Pierre, Professor
Sub-Investigator: Marc Deshayes, Doctor
Sub-Investigator: Richard Sarfati, Doctor
Sub-Investigator: Sabine Marcadet-Fredet

Sponsors and Collaborators

Poitiers University Hospital

Investigators

Principal Investigator:

Guillaume Magnin, Professor

Poitiers University Hospital

More Information

No publications provided

Study ID Numbers:	RUFIB
Study First Received:	September 16, 2005
Last Updated:	January 26, 2009
ClinicalTrials.gov Identifier:	NCT00219778 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Myofibroma
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists

Contraceptive Agents, Female
Connective Tissue Diseases
Mifepristone
Contraceptives, Postcoital
Hormones
Leiomyoma

Additional relevant MeSH terms:

Neoplasms, Muscle Tissue
Contraceptives, Postcoital, Synthetic
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Leiomyoma
Neoplasms, Connective and Soft Tissue
Therapeutic Uses
Menstruation-Inducing Agents

Abortifacient Agents
Connective Tissue Diseases
Contraceptives, Oral, Synthetic
Abortifacient Agents, Steroidal
Myofibroma
Neoplasms by Histologic Type
Mifepristone
Contraceptives, Postcoital
Luteolytic Agents
Pharmacologic Actions
Neoplasms
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on September 01, 2009