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Completed

NCT Number: NCT02271958

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

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Eusebio Hernández, "Maternidad Obrera"

Havana, La Habana, Cuba

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mifepristone

Drug

Placebo

Drug

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Mediterranea Medica S. L.

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 22, 2014
Registry last updated
Oct 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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