LeiomyomaPhase 3NCT00133705
Trial of Mifepristone for Fibroids
A Phase 3 study testing Mifepristone and Inert Capsule in people with Leiomyoma, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this trial is to determine if low-dose mifepristone benefits women with symptomatic fibroids. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Leiomyoma
- What is being tested?
- Mifepristone and Inert Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Jun 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gender: Female
- Age: 18 - premenopausal
- Have at least moderate symptoms of menorrhagia or pelvic pain/pressure
- Have a total uterine volume greater than or equal to 160 cc by ultrasound measurement and at least one fibroid that is => 2.5cm in size
- Have a score of equal to or greater than 39 on the Uterine Fibroid Symptom and Quality of Life scale
- Declined standard treatment options for symptomatic fibroids
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- Agree to use a double-barrier method (condoms, diaphragms) or other effective non-hormonal methods of contraception (abstinence, sterilization) throughout participation in the study to prevent pregnancy and to report any exposure to pregnancy to the research staff immediately
- Willing and able to give informed consent
- Willing and able to comply with study requirements
Who cannot join
- Current or planned pregnancy during the study period
- Menopausal, as indicated by follicle stimulating hormone (FSH) level of the reference laboratory
- Currently breast-feeding
- Untreated abnormal pap smear
- Presence of conditions other than fibroids contributing to pain and/or bleeding
- Hemoglobin < 9.0 mg/dl
Show all 34Show fewer
- Presence of adnexal masses or tenderness indicating further evaluation or surgery
- Grade III or IV hydronephrosis by ultrasound
- Severe, active mental health disorder
- Active substance abuse or dependence
- Presence of any contraindication to mifepristone including:
- Adrenal insufficiency by history
- Sickle cell disease
- Active liver disease (liver function tests greater than 1.5 times upper range of normal)
- Severe, respiratory disease (P02 saturation< 92%)
- Renal disease (serum creatinine > 1.5 mg/dl)
- Blood clotting defect. (abnormal PT and PTT)
- Thromboembolic disease (history of deep vein thrombosis or pulmonary embolus)
- Current or recent (within the past 3 months) use of the following medications:
- Oral or systemic corticosteroids
- Hormones: estrogens, progestins, oral contraceptives
- Danazol, anticoagulants
- Herbal or botanical supplements with possible hormonal effects.
- Use within the past six months of the gonadotropin releasing hormones (GnRH) analogs or Depo-Provera.
- Current or planned use during the study of any of the following medications/or products:
- ketoconazole,
- itraconazole,
- erythromycin,
- grapefruit juice,
- rifampin,
- St John's Wort,
- phenytoin,
- phenobarbital, or
- carbamazepine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester School of Medicine & Dentistry
Rochester, New York, 14642
About this study
Official title: Randomized Control Trial Of Mifepristone for Fibroids
The purpose of this trial is to determine if low-dose mifepristone benefits women with symptomatic fibroids.
Read the detailed description
This trial is designed to assess the efficacy and tolerability of mifepristone 5 mg given daily for 6 months to pre-menopausal women with symptomatic fibroids. The primary study outcome will be disease-specific quality of life. Secondary outcome measures include global quality of life, pain, bleeding, potential adverse effects, tumor size, and endometrial effects. The researchers will also examine a the effect of mifepristone on uterine blood flow. Randomization of study subjects will be stratified in order to ensure that equal numbers of women with moderate and severe symptoms will be enrolled in the placebo and control groups.
- Conditions
- Leiomyoma
- Being tested
- Mifepristone, Inert Capsule
- Keywords
- A benign tumor derived from smooth uterine muscle tissue.
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Also called RU486
Mifepristone 5mg/day by mouth for 6 months
Inert CapsuleDrug
sugar pill
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone | Experimental | Mifepristone 5 MG capsule taken once daily by mouth Receives: Drug: Mifepristone |
| Inert capsule | Placebo comparator | Placebo (for Mifepristone) capsule of nearly identical color, size, and weight taken once daily by mouth Receives: Drug: Inert Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine Volume
Uterine volume is measured in mLs
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 posted23 Aug 2005 (estimated)
- Study startJul 2003
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LeiomyomaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Kevin Fiscella, University of Rochester
- Investigators
- Kevin Fiscella, MD, MPH, Principal investigator, University of Rochester School of Medicine & Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133705
- Sponsor's protocol ID
- RO1-HD042578-2
- Other IDs
- R01HD042578
- Status last verified
- Sep 2023
- First submitted
- 22 Aug 2005
- Last updated
- 25 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Eisinger SH, Bonfiglio T, Fiscella K, Meldrum S, Guzick DS. Twelve-month safety and efficacy of low-dose mifepristone for uterine myomas. J Minim Invasive Gynecol. 2005 May-Jun;12(3):227-33. doi: 10.1016/j.jmig.2005.01.022.
PubMed 15922980Eisinger SH, Meldrum S, Fiscella K, le Roux HD, Guzick DS. Low-dose mifepristone for uterine leiomyomata. Obstet Gynecol. 2003 Feb;101(2):243-50. doi: 10.1016/s0029-7844(02)02511-5.
PubMed 12576246Fiscella K, Eisinger SH, Meldrum S, Feng C, Fisher SG, Guzick DS. Effect of mifepristone for symptomatic leiomyomata on quality of life and uterine size: a randomized controlled trial. Obstet Gynecol. 2006 Dec;108(6):1381-7. doi: 10.1097/01.AOG.0000243776.23391.7b.
PubMed 17138770
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial Of Mifepristone for Fibroids
- ClinicalTrials.gov ID
- NCT00133705
- Acronym / sponsor ID
- RO1-HD042578-2
- Conditions
- Leiomyoma
- Keywords
- A benign tumor derived from smooth uterine muscle tissue.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2003
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 23 Aug 2005 (estimated)
- Results
- Posted 30 Nov 2012
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 trial is to determine if low-dose mifepristone benefits women with symptomatic fibroids.
Detailed description
This trial is designed to assess the efficacy and tolerability of mifepristone 5 mg given daily for 6 months to pre-menopausal women with symptomatic fibroids. The primary study outcome will be disease-specific quality of life. Secondary outcome measures include global quality of life, pain, bleeding, potential adverse effects, tumor size, and endometrial effects. The researchers will also examine a the effect of mifepristone on uterine blood flow. Randomization of study subjects will be stratified in order to ensure that equal numbers of women with moderate and severe symptoms will be enrolled in the placebo and control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mifepristone | Experimental | Drug: MifepristoneMifepristone 5 MG capsule taken once daily by mouth |
| Inert capsule | Placebo comparator | Drug: Inert CapsulePlacebo (for Mifepristone) capsule of nearly identical color, size, and weight taken once daily by mouth |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Gender: Female
- Age: 18 - premenopausal
- Have at least moderate symptoms of menorrhagia or pelvic pain/pressure
- Have a total uterine volume greater than or equal to 160 cc by ultrasound measurement and at least one fibroid that is => 2.5cm in size
- Have a score of equal to or greater than 39 on the Uterine Fibroid Symptom and Quality of Life scale
Key exclusion criteria (34 listed)
- Current or planned pregnancy during the study period
- Menopausal, as indicated by follicle stimulating hormone (FSH) level of the reference laboratory
- Currently breast-feeding
- Untreated abnormal pap smear
- Presence of conditions other than fibroids contributing to pain and/or bleeding
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 |
|---|---|---|
| MifepristoneAlso: RU486Mifepristone 5mg/day by mouth for 6 months | Drug | Mifepristone |
| Inert Capsulesugar pill | Drug | Inert capsule |
Primary outcome
Uterine Volume
Time frame: 6 months
Uterine volume is measured in mLs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15922980Eisinger SH, Bonfiglio T, Fiscella K, Meldrum S, Guzick DS. Twelve-month safety and efficacy of low-dose mifepristone for uterine myomas. J Minim Invasive Gynecol. 2005 May-Jun;12(3):227-33. doi: 10.1016/j.jmig.2005.01.022.
- Background: PubMed 12576246Eisinger SH, Meldrum S, Fiscella K, le Roux HD, Guzick DS. Low-dose mifepristone for uterine leiomyomata. Obstet Gynecol. 2003 Feb;101(2):243-50. doi: 10.1016/s0029-7844(02)02511-5.
- Derived from this study: PubMed 17138770Fiscella K, Eisinger SH, Meldrum S, Feng C, Fisher SG, Guzick DS. Effect of mifepristone for symptomatic leiomyomata on quality of life and uterine size: a randomized controlled trial. Obstet Gynecol. 2006 Dec;108(6):1381-7. doi: 10.1097/01.AOG.0000243776.23391.7b.
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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.
Kevin Fiscella, MD, MPH principal investigator
University of Rochester School of Medicine & Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mifepristone and Inert Capsule in people with Leiomyoma, run by University of Rochester at 1 site in United States.
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 9 inclusion and 34 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 25 Sep 2023. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Yes. Results are posted in the registry (first posted 30 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Uterine Volume (time frame: 6 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 NCT00133705, which also lists 3 linked publications.
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 25 Sep 2023.