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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02271958
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : October 22, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Josep Lluis Carbonell i Esteve, Mediterranea Medica S. L.

Brief 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.


Condition or disease Intervention/treatment Phase
Endometriosis Drug: Mifepristone Drug: PLACEBO Phase 2 Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Mifepristone 2.5, 5, 10 mg Versus Placebo in the Treatment of Endometriosis
Study Start Date : November 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: Group 1
Oral administration of 2,5 mg of mifepristone daily for 6 months
Drug: Mifepristone
Experimental: Group 2
Oral administration of 5 mg of mifepristone daily for 6 months
Drug: Mifepristone
Experimental: Group 3
Oral administration of 10 mg of mifepristone daily for 6 months
Drug: Mifepristone
Experimental: Group 4
Oral administration of mifepristone placebo daily for 3 months
Drug: PLACEBO



Primary Outcome Measures :
  1. Changes in prevalence of dysmenorrhea and the average reduction in its intensity. [ Time Frame: 6 months ]
    The principal variables in evaluating effectiveness were the percentage changes in prevalence of dysmenorrhea and the average reduction in its intensity.

  2. Incidence of hot flushes, nausea, dizzy spells, vomiting, fatigue/tiredness, raised hepatic transaminases, histological alterations of the endometrium. [ Time Frame: 6 months ]
    Safety was evaluated by the incidence of hot flushes, nausea, dizzy spells, vomiting, fatigue/tiredness, raised hepatic transaminases, histological alterations of the endometrium.

  3. Changes in scores according to American Fertility Society (AFS) [ Time Frame: 6 months ]
    Effectiveness was assessed by measuring changes in scores according to American Fertility Society (AFS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271958


Locations
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Cuba
Hospital Eusebio Hernández, "Maternidad Obrera"
Havana, Cuba
Sponsors and Collaborators
Mediterranea Medica S. L.
Investigators
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Principal Investigator: Josep Ll Carbonell, Doctor Medical Clinic Mediterranea

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Responsible Party: Dr. Josep Lluis Carbonell i Esteve, Medical Director, Mediterranea Medica S. L.
ClinicalTrials.gov Identifier: NCT02271958     History of Changes
Other Study ID Numbers: Endomife 2,5/5/10/placebo
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: October 22, 2014
Last Verified: October 2014
Keywords provided by Dr. Josep Lluis Carbonell i Esteve, Mediterranea Medica S. L.:
Mifepristone
Endometriosis
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents