A Phase 2/3 interventional study of Oral administration of mifepristone 2.5 mg daily for three months and Oral administration of mifepristone 5 mg daily for three months in Uterine Fibroids, sponsored by Mediterranea Medica S. L.. Terminated at 1 site in Cuba. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2014-09-05.
Sponsored by Mediterranea Medica S. L. · Phase 2/3, Interventional, and Treatment
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.
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.
438 studies on the registry are indexed under Leiomyoma; 74 are open to participants now.
This study's enrollment of 220 is above the median of 66 across 306 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →Mediterranea Medica S. L. is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Experimental: 1
Drug: Oral administration of mifepristone 2.5 mg daily for three months
Experimental: 2
Drug: Oral administration of mifepristone 5 mg daily for three months
Experimental: 1
Also known as: Low doses of antiprogestins to treat uterine fibroids
Experimental: 2
Also known as: Low doses of antiprogestins to treat uterine fibroids
Volume of the uterine leiomyomata with 2,5mg vs 5 mg daily of mifepristone after 3 months of treatment
Evaluate efficacy were the percentage changes in fibroid volumes before starting, 3 into treatment and 3, 6, and 9 months after its termination
Time frame: 3 months
Volume of the uterus with 2,5 mg vs 5 md daily of mifepristone after 3 months of treatment.
Evaluate efficacy were the percentage changes in uterus volumes before starting, 3 into treatment and 3, 6, and 9 months after its termination
Time frame: 3 months
The record gives a start of Mar 2010, a primary completion of Mar 2012 and a completion of Mar 2012. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Mediterranea Medica S. L.