Mifepristone 2.5, 5, 10 mg Versus Placebo in the Treatment of Endometriosis

Endometriosis Clinical Trial

Official title:

Mifepristone 2.5, 5, 10 mg Versus Placebo in the Treatment of Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271958
• Other study ID #: Endomife 2,5/5/10/placebo
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 4, 2014
• Last updated: October 20, 2014
• Start date: November 2010
• Est. completion date: December 2013

Study information

• Verified date: October 2014
• Source: Mediterranea Medica S. L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: Scientific and Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Women with laparoscopic confirmed diagnosis of endometriosis

• Age between 18 and 45

• Certain diagnosis of endometriosis of any degree corresponding to the American Fertility Society (AFS)

• Patients with symptoms of endometriosis: dysmenorrhea or pelvic pain not attributable to other gynecological illness and

• Acceptance of the use of barrier contraceptive methods during the study

Exclusion Criteria:

• Breastfeeding

• Hormonal or surgical treatment for the endometriosis less than 4 months previous to study

• Diabetes

• Severe arterial hypertension

• Hepatopathy

• Renal malfunction

• Endocrinopathy

• Any other contraindication regarding the use of antiprogestins.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Mifepristone

• PLACEBO

Locations

Country	Name	City	State
Cuba	Hospital Eusebio Hernández, "Maternidad Obrera"	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Mediterranea Medica S. L.

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No
Primary	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.	6 months	Yes
Primary	Changes in scores according to American Fertility Society (AFS)	Effectiveness was assessed by measuring changes in scores according to American Fertility Society (AFS)	6 months	No