EndometriosisPhase 2/3NCT02271958
Mifepristone 2.5, 5, 10 mg Versus Placebo in the Treatment of Endometriosis
A Phase 2/3 study testing Mifepristone in people with Endometriosis, run by Mediterranea Medica S. L. at 1 site in Cuba.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Mifepristone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteCuba
- Study dates
- Nov 2010to Dec 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Endometriosis
- Being tested
- Mifepristone, PLACEBO
- Keywords
- Mifepristone, Endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
PLACEBODrug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Oral administration of 2,5 mg of mifepristone daily for 6 months Receives: Drug: Mifepristone |
| Group 2 | Experimental | Oral administration of 5 mg of mifepristone daily for 6 months Receives: Drug: Mifepristone |
| Group 3 | Experimental | Oral administration of 10 mg of mifepristone daily for 6 months Receives: Drug: Mifepristone |
| Group 4 | Experimental | Oral administration of mifepristone placebo daily for 3 months Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startNov 2010
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mediterranea Medica S. L.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Josep Lluis Carbonell i Esteve, Mediterranea Medica S. L.
- Investigators
- Josep Ll Carbonell, Doctor, Principal investigator, Medical Clinic Mediterranea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271958
- Sponsor's protocol ID
- Endomife 2,5/5/10/placebo
- Status last verified
- Oct 2014
- First submitted
- 4 Sep 2014
- Last updated
- 22 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 41065045
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mifepristone 2.5, 5, 10 mg Versus Placebo in the Treatment of Endometriosis
- ClinicalTrials.gov ID
- NCT02271958
- Acronym / sponsor ID
- Endomife 2,5/5/10/placebo
- Conditions
- Endometriosis
- Keywords
- Mifepristone, Endometriosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Mediterranea Medica S. L.University, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: MifepristoneOral administration of 2,5 mg of mifepristone daily for 6 months |
| Group 2 | Experimental | Drug: MifepristoneOral administration of 5 mg of mifepristone daily for 6 months |
| Group 3 | Experimental | Drug: MifepristoneOral administration of 10 mg of mifepristone daily for 6 months |
| Group 4 | Experimental | Drug: PLACEBOOral administration of mifepristone placebo daily for 3 months |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Breastfeeding
- Hormonal or surgical treatment for the endometriosis less than 4 months previous to study
- Diabetes
- Severe arterial hypertension
- Hepatopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mifepristone | Drug | Group 1, Group 2, Group 3 |
| PLACEBO | Drug | Group 4 |
Primary outcome
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.
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.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2014.
- Derived from this study: PubMed 41065045Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep Ll Carbonell, Doctor principal investigator
Medical Clinic Mediterranea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mifepristone in people with Endometriosis, run by Mediterranea Medica S. L. at 1 site in Cuba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cuba. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in prevalence of dysmenorrhea and the average reduction in its intensity. (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02271958, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2014.