Mifepristone to Treat Uterine Fibroids

Mediterranea Medica S. L.

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Uterine Fibroids

Treatments: Drug: Oral administration of mifepristone 5 mg daily for three months; Drug: Oral administration of mifepristone 2.5 mg daily for three months

Study type: Interventional

Funder types: Other

Identifiers

NCT01786226

Fibroma2.5normal

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Mifepristone 2.5 mg daily for three months

Experimental group

Description:

Experimental: 1

Treatment:

Drug: Oral administration of mifepristone 2.5 mg daily for three months

Mifepristone 5 mg daily for three months

Experimental group

Description:

Experimental: 2

Treatment:

Drug: Oral administration of mifepristone 5 mg daily for three months