NCT02271958

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
Last Updated

October 22, 2014

Status Verified

October 1, 2014

Enrollment Period

2.9 years

First QC Date

September 4, 2014

Last Update Submit

October 20, 2014

Conditions

Endometriosis

Keywords

MifepristoneEndometriosis

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (4)

Group 1

EXPERIMENTAL

Oral administration of 2,5 mg of mifepristone daily for 6 months

Drug: Mifepristone

Group 2

EXPERIMENTAL

Oral administration of 5 mg of mifepristone daily for 6 months

Drug: Mifepristone

Group 3

EXPERIMENTAL

Oral administration of 10 mg of mifepristone daily for 6 months

Drug: Mifepristone

Group 4

EXPERIMENTAL

Oral administration of mifepristone placebo daily for 3 months

Drug: PLACEBO

Interventions

MifepristoneDRUG
Group 1Group 2Group 3
PLACEBODRUG
Group 4

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Eusebio Hernández, "Maternidad Obrera"

Havana, La Habana, Cuba

Location

Related Publications (1)

  • Chen I, Kives S, Zakhari A, Nguyen DB, Goldberg HR, Choudhry AJ, Le AL, Kowalczewski E, Schroll JB. Progestagens for pain symptoms associated with endometriosis. Cochrane Database Syst Rev. 2025 Oct 9;10(10):CD002122. doi: 10.1002/14651858.CD002122.pub3.

    PMID: 41065045DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Josep Ll Carbonell, Doctor

    Medical Clinic Mediterranea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

September 4, 2014

First Posted

October 22, 2014

Study Start

November 1, 2010

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

October 22, 2014

Record last verified: 2014-10

Locations

CU(1)