A Phase 2/3 interventional study of Mifepristone in Uterine Fibroids, sponsored by Mediterranea Medica S. L.. Completed at 1 site in Cuba. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2014-10-17.
Sponsored by Mediterranea Medica S. L. · Phase 2/3, Interventional, and Treatment
The objectives of this study are to estimate the efficacy and safety of the daily administration for 6 months of 5 mg versus 10 mg. A 6 month follow-up of subjects is carried out to estimate how the effects of mifepristone are kept in time.
The hypothesis of this study is that both mifepristone doses reduce the volume of the myoma up to 50% in six months treatment.
Women, in fertile age or premenopausal status, presenting symptomatic myomaswere randomly assigned to receive 5 or 10 mg of mifepristone for six months.
The decreasing in the prevalence of symptoms attributable to myomas is an important goal to achieve under both treatments. Another goal is to maintain for more than 6 months the benefits of the treatment with mifepristone.
438 studies on the registry are indexed under Leiomyoma; 74 are open to participants now.
This study's enrollment of 100 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.
Counted across the registry records on this site, refreshed daily.
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.
Oral administration of mifepristone 5 mg daily for six months.
Drug: Mifepristone
Oral administration of mifepristone 10 mg daily for six months.
Drug: Mifepristone
Volume of the uterine leiomyomata with 5 versus 10 mg of mifepristone daily after six months of treatment
Time frame: 6 months
Prevalence of symptoms after 6 months treatment with 5 or 10 mg of mifepristone.
Time frame: 6 months
The record gives a start of May 2008, a primary completion of Apr 2009 and a completion of May 2009. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mifepristone
Mediterranea Medica S. L.