A Phase 2/3 interventional study of Mifepristone and PLACEBO in Endometriosis, sponsored by Mediterranea Medica S. L.. Completed at 1 site in Cuba. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2014-10-22.
Sponsored by Mediterranea Medica S. L. · Phase 2/3, Interventional, and Treatment
The purpose of this study is to evaluate the effectiveness and safety of 2.5, 5 and 10 mg doses of mifepristone against a placebo in women with laparoscopic diagnostic of endometriosis.
The hypothesis of the study is that the 5 mg mifepristone dose is safe and effective and should be used in future studies on medical treatment of endometriosis.
This is double-blind randomized clinical trial.
Examinations undertaken Thorough gynecological examination, pelvic ultrasound examination, diagnostic laparoscopy before starting treatment in order to determine the localization, extent and degree of severity of the endometrial lesions and a score was assigned in accordance with the revised American Fertility Society (AFS) classification.19 Blood samples were taken for hematological tests and hepatic function. Endometrial biopsy was performed if endometrial thickness as calibrated by ultrasound was >8 mm or if there had been abnormal bleeding in the past 3 months. After 90 and 180 days of treatment an ultrasound examination of the pelvis was carried out and then followed by diagnostic-therapeutic laparoscopy and endometrial biopsy.
Subjects Women with laparoscopic confirmed diagnosis of endometriosis who volunteered to take part in the study. Inclusion criteria: a) age between 18 and 45, b) certain diagnosis of endometriosis of any degree corresponding to the American Fertility Society (AFS); c) patients with symptoms of endometriosis: dysmenorrhea or pelvic pain not attributable to other gynecological illness and d) acceptance of the use of barrier contraceptive methods during the study. Exclusion criteria: a) breastfeeding, b) hormonal or surgical treatment for the endometriosis less than 4 months previous to study, c) diabetes, d) severe arterial hypertension, e) hepatopathy, f) renal malfunction, g) endocrinopathy, and f) any other contraindication regarding the use of antiprogestins.
920 studies on the registry are indexed under Endometriosis; 266 are open to participants now.
This study's enrollment of 360 is above the median of 67 across 540 interventional studies indexed under Endometriosis.
Browse Endometriosis 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 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.
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 2,5 mg of mifepristone daily for 6 months
Drug: Mifepristone
Oral administration of 5 mg of mifepristone daily for 6 months
Drug: Mifepristone
Oral administration of 10 mg of mifepristone daily for 6 months
Drug: Mifepristone
Oral administration of mifepristone placebo daily for 3 months
Drug: PLACEBO
Changes in prevalence of dysmenorrhea and the average reduction in its intensity.
The principal variables in evaluating effectiveness were the percentage changes in prevalence of dysmenorrhea and the average reduction in its intensity.
Time frame: 6 months
Incidence of hot flushes, nausea, dizzy spells, vomiting, fatigue/tiredness, raised hepatic transaminases, histological alterations of the endometrium.
Safety was evaluated by the incidence of hot flushes, nausea, dizzy spells, vomiting, fatigue/tiredness, raised hepatic transaminases, histological alterations of the endometrium.
Time frame: 6 months
Changes in scores according to American Fertility Society (AFS)
Effectiveness was assessed by measuring changes in scores according to American Fertility Society (AFS)
Time frame: 6 months
The record gives a start of Nov 2010, a primary completion of Oct 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.
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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