Mifepristone to Treat Uterine Fibroids
This study has been terminated.
Sponsor:
Mediterranea Medica S. L.
Information provided by (Responsible Party):
Dr. Josep LLuis Carbonell i Esteve, Mediterranea Medica S. L.
ClinicalTrials.gov Identifier:
NCT01786226
First received: February 5, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
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Purpose
Objectives: to evaluate the efficacy, safety and quality of life by using 2.5 and mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9 months follow-up period.
The hypothesis of the study is that the 2.5 mg dosage resulted in a lesser reduction in fibroid size but a similar improvement in quality of life when compared to the 5 mg dose.
| Condition | Intervention | Phase |
|---|---|---|
|
Uterine Fibroids |
Drug: Oral administration of mifepristone 2.5 mg daily for three months Drug: Oral administration of mifepristone 5 mg daily for three months |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Uterine Myoma With 2.5 or 5 mg Mifepristone Daily During 3 Months With 9 Months Post-treatment Follow-up. Randomized Clinical Trial. |
Resource links provided by NLM:
Further study details as provided by Mediterranea Medica S. L.:
Primary Outcome Measures:
- Volume of the uterine leiomyomata with 2,5mg vs 5 mg daily of mifepristone after 3 months of treatment [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Evaluate efficacy were the percentage changes in fibroid volumes before starting, 3 into treatment and 3, 6, and 9 months after its termination
Secondary Outcome Measures:
- Volume of the uterus with 2,5 mg vs 5 md daily of mifepristone after 3 months of treatment. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Evaluate efficacy were the percentage changes in uterus volumes before starting, 3 into treatment and 3, 6, and 9 months after its termination
| Enrollment: | 220 |
| Study Start Date: | March 2010 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Mifepristone 2.5 mg daily for three months
Experimental: 1
|
Drug: Oral administration of mifepristone 2.5 mg daily for three months
Experimental: 1
Other Name: Low doses of antiprogestins to treat uterine fibroids
|
|
Experimental: Mifepristone 5 mg daily for three months
Experimental: 2
|
Drug: Oral administration of mifepristone 5 mg daily for three months
Experimental: 2
Other Name: Low doses of antiprogestins to treat uterine fibroids
|
Detailed Description:
Women, in fertile age or in premenopausal status, presenting symptomatic uterine fibroids were randomly assigned to receive 5 mg or 10 of mifepristone.
The diminishing of prevalence of symptoms attributable to uterine fibroids is the most important goal to achieve under both treatments. The possible side effects of mifepristone are slight and women's adherence to treatment is remarkable. Also the reduction of the volumes of the uterus and fibroids contribute to enhance the wellbeing of subjects.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Symptomatic uterine leiomyomata
- Reproductive age or premenopausal
- Accepting the use of non hormonal contraception
- Conformity in keeping a monthly log of all episodes of vaginal bleeding during the treatment as well as all side effects of mifepristone
- Agreeing to have ultrasound examinations in every follow-up or evaluation visit
- Agreeing to two endometrial biopsies: one before starting treatment and another in the following 10 days after treatment termination
Exclusion Criteria:
- Pregnancy or desire to become pregnant
- Breastfeeding
- Hormonal contraception or any hormonal therapy received in the last three months
- Signs or symptoms of pelvic inflammatory disease
- Adnexal masses
- Abnormal or unexplained vaginal bleeding
- Suspected or diagnosed malignant neoplastic disease
- Signs or symptoms of mental illness
- Adrenal disease
- Sickle cell anemia
- Hepatic disease
- Renal disease
- Coagulopathy
- Any other severe or important disease
- Any contraindication to receiving antiprogestins
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dr. Josep LLuis Carbonell i Esteve, Medical Director, Mediterranea Medica S. L. |
| ClinicalTrials.gov Identifier: | NCT01786226 History of Changes |
| Other Study ID Numbers: | Fibroma2.5normal |
| Study First Received: | February 5, 2013 |
| Last Updated: | February 5, 2013 |
| Health Authority: | Cuba: Scientific and Ethics Committee |
Keywords provided by Mediterranea Medica S. L.:
|
leiomyoma, fibroid, mifepristone, antiprogestins |
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 16, 2013