Uterine FibroidsPhase 2/3NCT01786226
Mifepristone to Treat Uterine Fibroids
A Phase 2/3 study testing Oral administration of mifepristone 2.5 mg daily for three months and Oral administration of mifepristone 5 mg daily for three months in people with Uterine Fibroids, run by Mediterranea Medica S. L. at 1 site in Cuba.
Trial summary
Objectives: to evaluate the efficacy, safety and quality of life by using 2.5 and mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9 months follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- Oral administration of mifepristone 2.5 mg daily for three months and Oral administration of mifepristone 5 mg daily for three months
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteCuba
- Study dates
- Mar 2010to Mar 2012
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Symptomatic uterine leiomyomata
- Reproductive age or premenopausal
- Accepting the use of non hormonal contraception
- Conformity in keeping a monthly log of all episodes of vaginal bleeding during the treatment as well as all side effects of mifepristone
- Agreeing to have ultrasound examinations in every follow-up or evaluation visit
- Agreeing to two endometrial biopsies: one before starting treatment and another in the following 10 days after treatment termination
Who cannot join
- Pregnancy or desire to become pregnant
- Breastfeeding
- Hormonal contraception or any hormonal therapy received in the last three months
- Signs or symptoms of pelvic inflammatory disease
- Adnexal masses
- Abnormal or unexplained vaginal bleeding
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- Suspected or diagnosed malignant neoplastic disease
- Signs or symptoms of mental illness
- Adrenal disease
- Sickle cell anemia
- Hepatic disease
- Renal disease
- Coagulopathy
- Any other severe or important disease
- Any contraindication to receiving antiprogestins
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Uterine Myoma With 2.5 or 5 mg Mifepristone Daily During 3 Months With 9 Months Post-treatment Follow-up. Randomized Clinical Trial.
Objectives: to evaluate the efficacy, safety and quality of life by using 2.5 and mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9 months follow-up period.
The hypothesis of the study is that the 2.5 mg dosage resulted in a lesser reduction in fibroid size but a similar improvement in quality of life when compared to the 5 mg dose.
Read the detailed description
Women, in fertile age or in premenopausal status, presenting symptomatic uterine fibroids were randomly assigned to receive 5 mg or 10 of mifepristone.
The diminishing of prevalence of symptoms attributable to uterine fibroids is the most important goal to achieve under both treatments. The possible side effects of mifepristone are slight and women's adherence to treatment is remarkable. Also the reduction of the volumes of the uterus and fibroids contribute to enhance the wellbeing of subjects.
- Conditions
- Uterine Fibroids
- Being tested
- Oral administration of mifepristone 2.5 mg daily for three months, Oral administration of mifepristone 5 mg daily for three months
- Keywords
- leiomyoma, fibroid, mifepristone, antiprogestins
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral administration of mifepristone 2.5 mg daily for three monthsDrug
Also called Low doses of antiprogestins to treat uterine fibroids
Experimental: 1
Oral administration of mifepristone 5 mg daily for three monthsDrug
Also called Low doses of antiprogestins to treat uterine fibroids
Experimental: 2
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone 2.5 mg daily for three months | Experimental | Experimental: 1 Receives: Drug: Oral administration of mifepristone 2.5 mg daily for three months |
| Mifepristone 5 mg daily for three months | Experimental | Experimental: 2 Receives: Drug: Oral administration of mifepristone 5 mg daily for three months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of the uterine leiomyomata with 2,5mg vs 5 mg daily of mifepristone after 3 months of treatment
Evaluate efficacy were the percentage changes in fibroid volumes before starting, 3 into treatment and 3, 6, and 9 months after its termination
Measured: 3 months
Secondary outcomes (1)
Volume of the uterus with 2,5 mg vs 5 md daily of mifepristone after 3 months of treatment.
Evaluate efficacy were the percentage changes in uterus volumes before starting, 3 into treatment and 3, 6, and 9 months after its termination
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startMar 2010
- Primary completionMar 2012
- Study completionMar 2012
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 Uterine FibroidsStudies 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
- None (open label)
- Enrolment
- 220 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.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786226
- Sponsor's protocol ID
- Fibroma2.5normal
- Status last verified
- Sep 2014
- First submitted
- 5 Feb 2013
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carbonell JL, Acosta R, Perez Y, Garces R, Sanchez C, Tomasi G. Treatment of Uterine Myoma with 2.5 or 5 mg Mifepristone Daily during 3 Months with 9 Months Posttreatment Followup: Randomized Clinical Trial. ISRN Obstet Gynecol. 2013 Jul 29;2013:649030. doi: 10.1155/2013/649030. eCollection 2013.
PubMed 23984082
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Uterine Myoma With 2.5 or 5 mg Mifepristone Daily During 3 Months With 9 Months Post-treatment Follow-up. Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01786226
- Acronym / sponsor ID
- Fibroma2.5normal
- Conditions
- Uterine Fibroids
- Keywords
- leiomyoma, fibroid, mifepristone, antiprogestins
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Mediterranea Medica S. L.University, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 7 Feb 2013 (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.
Objectives: to evaluate the efficacy, safety and quality of life by using 2.5 and mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9 months follow-up period.
The hypothesis of the study is that the 2.5 mg dosage resulted in a lesser reduction in fibroid size but a similar improvement in quality of life when compared to the 5 mg dose.
Detailed description
Women, in fertile age or in premenopausal status, presenting symptomatic uterine fibroids were randomly assigned to receive 5 mg or 10 of mifepristone.
The diminishing of prevalence of symptoms attributable to uterine fibroids is the most important goal to achieve under both treatments. The possible side effects of mifepristone are slight and women's adherence to treatment is remarkable. Also the reduction of the volumes of the uterus and fibroids contribute to enhance the wellbeing of subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mifepristone 2.5 mg daily for three months | Experimental | Drug: Oral administration of mifepristone 2.5 mg daily for three monthsExperimental: 1 |
| Mifepristone 5 mg daily for three months | Experimental | Drug: Oral administration of mifepristone 5 mg daily for three monthsExperimental: 2 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Symptomatic uterine leiomyomata
- Reproductive age or premenopausal
- Accepting the use of non hormonal contraception
- Conformity in keeping a monthly log of all episodes of vaginal bleeding during the treatment as well as all side effects of mifepristone
- Agreeing to have ultrasound examinations in every follow-up or evaluation visit
Key exclusion criteria (15 listed)
- Pregnancy or desire to become pregnant
- Breastfeeding
- Hormonal contraception or any hormonal therapy received in the last three months
- Signs or symptoms of pelvic inflammatory disease
- Adnexal masses
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 |
|---|---|---|
| Oral administration of mifepristone 2.5 mg daily for three monthsAlso: Low doses of antiprogestins to treat uterine fibroidsExperimental: 1 | Drug | Mifepristone 2.5 mg daily for three months |
| Oral administration of mifepristone 5 mg daily for three monthsAlso: Low doses of antiprogestins to treat uterine fibroidsExperimental: 2 | Drug | Mifepristone 5 mg daily for three months |
Primary outcome
Volume of the uterine leiomyomata with 2,5mg vs 5 mg daily of mifepristone after 3 months of treatment
Time frame: 3 months
Evaluate efficacy were the percentage changes in fibroid volumes before starting, 3 into treatment and 3, 6, and 9 months after its termination
1 secondary outcome
Volume of the uterus with 2,5 mg vs 5 md daily of mifepristone after 3 months of treatment.
Time frame: 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
- Results publication: PubMed 23984082Carbonell JL, Acosta R, Perez Y, Garces R, Sanchez C, Tomasi G. Treatment of Uterine Myoma with 2.5 or 5 mg Mifepristone Daily during 3 Months with 9 Months Posttreatment Followup: Randomized Clinical Trial. ISRN Obstet Gynecol. 2013 Jul 29;2013:649030. doi: 10.1155/2013/649030. eCollection 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Oral administration of mifepristone 2.5 mg daily for three months and Oral administration of mifepristone 5 mg daily for three months in people with Uterine Fibroids, 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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 5 Sep 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 was stopped early. Results are not available in the source record.
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?
Volume of the uterine leiomyomata with 2,5mg vs 5 mg daily of mifepristone after 3 months of treatment (time frame: 3 months). 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 NCT01786226, 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 5 Sep 2014.