Fibroid UterusPhase 2NCT03400826
Effects of Simvastatin on Uterine Leiomyoma Size
A Phase 2 study testing Simvastatin 40mg in people with Fibroid Uterus and Fibroid Tumor, run by Johns Hopkins University at 1 site in United States.
Trial summary
The study aims to study the effect of simvastatin on the size of uterine fibroids. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Fibroid Uterus, Fibroid Tumor, Leiomyoma
- What is being tested?
- Simvastatin 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2018to 31 Jul 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed written consent.
- Gender: female.
- Age: 18-55 years at time of signing consent.
- BMI of subjects: < 45 kg/m2.
- Uterine fibroids:
- Diagnosed by ultrasound (MRI will be used only if ultrasound is inconclusive).
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- Number: any number of fibroids.
- Location: submucosal or intramural.
- At least one fibroid of diameter > 3cm.
- Symptoms: one or more of the following symptoms of heavy menstrual bleeding (HMB), defined as: Experienced cyclic (22 to 35 days) abnormal uterine bleeding (heavy or prolonged) in at least 3 of the last 6 menstrual periods, including menstrual bleeding lasting 5 or more days or heavy bleeding per participant recall. Examples of heavy bleeding may include, but are not limited to the following:
- Requires the use of double protection to manage menstrual bleeding.
- Menstrual bleeding accompanied by the sensation of "gushing" or "flooding".
- Saturates more than 1 tampon or sanitary pad per hour for 3 or more consecutive hours.
- Regularly needs to change the tampon or sanitary pad at night or regularly soils bedclothes.
- Heavy bleeding that affects work, school, or social activities.
- Pelvic pain/ pressure likely caused by fibroids.
- Plan for surgery (hysterectomy or myomectomy).
- Normal Pap smear within the last year.
- Use of contraception during study such as non-hormonal oral contraceptives, intrauterine devices (IUD)/ intrauterine systems (IUS), barrier contraceptives, abstinence or sterilization.
Who cannot join
- Pregnancy or lactation.
- Previous or current uterine, cervical or ovarian cancer.
- Current endometrial hyperplasia or history of atypical endometrial hyperplasia. Endometrial biopsy will be done during screening (if not done within last 12 months).
- Suspicion of leiomyosarcoma.
- Recent rapid growth of fibroids (i.e. doubling in size within 1-6 months period).
- Unevaluated gynecologic abnormalities (unexplained vaginal bleeding, cervical dysplasia, or abnormal adnexal/ovarian mass).
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- Menopausal status.
- Surgery is urgently indicated (< 3 months) for medical or social reasons.
- Hemoglobin ≤ 6 g/dL.
- Currently enrolled in another investigational study.
- Mental condition or other barrier preventing informed written consent.
- Allergy or hypersensitivity to simvastatin.
- Current use of simvastatin or other drugs of the same class.
- Concomitant administration of strong CYP3A4 inhibitors including itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone, and cobicistat-containing products.
- Concomitant administration of gemfibrozil, cyclosporine, or danazol, verapamil, diltiazem, amiodarone, diltiazem, dronedarone, amlodipine, ranolazine, lomitapide, and grapefruit juice.
- Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels.( elevation of aspartate transaminase and/or alanine transaminase > 2 s.d. above the normal range at screening visit)
- Known increased risk or diagnosis of a myopathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blinded, Phase II, Randomized Control Trial to Study the Effects of Simvastatin in Patients With Uterine Leiomyoma
The study aims to study the effect of simvastatin on the size of uterine fibroids.
Read the detailed description
The study is a phase II double blinded clinical trial to determine feasibility, safety and preliminary clinical efficacy of simvastatin to reduce leiomyoma size. Women with symptomatic fibroids planned to undergo surgical management for fibroids such as hysterectomy or myomectomy will be screened for participation. The eligible women will undergo pre-study evaluation to ascertain study eligibility.The study will enroll 60 participants in total, half will receive simvastatin and the other half will receive a placebo. The study drug and placebo will be an add on to the participants ongoing medical management of fibroids until surgery. The participants will be monitored at intervals for the effect of the drug on fibroid size and symptoms using ultrasound and quality of life questionnaires.
- Conditions
- Fibroid Uterus, Fibroid Tumor, Leiomyoma, Fibromyoma, Leiomyoma, Uterine
- Being tested
- Simvastatin 40mg, Placebo 40 mg
- Keywords
- simvastatin, fibroids, medical management, uterine fibroids, leiomyoma
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin 40mgDrug
Also called Simvastatin
The Treatment Group subjects will orally intake encapsulated Simvastatin 40 mg tablets daily for the 12 weeks duration with water in the evening.
Placebo 40 mgDrug
Also called Starch 1500 encapsulated
The Placebo group will orally intake encapsulated Starch 1500, 40 mg Placebo for 12 weeks duration with water in the evening.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | The 30 participants randomized in this group will intake Simvastatin 40mg / day of orally at the same time in the evening, every day for the study duration of 12 weeks prior to undergoing hysterectomy/ myomectomy. The fibroid samples will be collected after the surgery to evaluate the effects of the study medication on the fibroid tissue. Receives: Drug: Simvastatin 40mg |
| Placebo Group | Placebo comparator | The 30 participants randomized in this group will intake Placebo 40mg / day orally at the same time in the evening every day for the study duration of 12 weeks prior to undergoing hysterectomy/ myomectomy. The fibroid samples will be collected after the surgery to evaluate the effects of the study medication on the fibroid tissue. Receives: Drug: Placebo 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tumor size volume pre and post study intervention
Tumor size measured by ultrasound imaging comparing tumor volume using ultrasound imaging. The volume will be reported in Centimeter cubes. The largest radius of the tumor will be used to calculate the volume, this will be measured in centimeters.
Measured: Change from baseline to 12 weeks post intervention
Secondary outcomes (3)
Clinical symptom improvement as determined by the Uterine Fibroid Symptom and Health Related Quality of Life Questionnaire.
The questionnaire used is the Uterine Fibroid Symptom and Health Related Quality of Life Questionnaire. This questionnaire is an effective and validated tool for detecting differences in symptom severity and health-related quality of life among patients with uterine fibroids. The scale for this questionnaire denotes symptom severity with lowest and highest possible scores of 8 and 40 respectively. Higher scores indicate greater severity of symptoms.
Measured: At visit 1 (Screening), At visit 2 (start of the study drug intake), visit 3 (6 weeks after start of the study drug), visit 4( 12 weeks after start of the study drug), and follow up visit at 2 and 6 weeks post hysterectomy
Adherence to the recommended treatment dosing
Based on review of patient diaries and counting of left over medications bought back by the subject. This will be reported as an overall percentage.
Measured: At Visit 3 (6 weeks after start of study drug), and Visit 4 (12 weeks after start of the study drug)
Subject retention
Based on presence at follow up visits to the study site. This will be determined as a simple percentage of subjects that stay in the study until the last visit.
Measured: At visit 2 (start of the study drug intake), visit 3 (6 weeks after start of the study drug), visit 4 (12 weeks after start of the study drug), and follow up visit at 2 and 6 weeks post hysterectomy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start20 Aug 2018
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
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 Fibroid UterusStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Mostafa Borahay, MD, PhD, Principal investigator, Johsn Hopkins School Of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400826
- Sponsor's protocol ID
- IRB00149869
- Other IDs
- 1R01HD094380-01
- Status last verified
- Jul 2026
- First submitted
- 9 Jan 2018
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Britten J, Roura-Monllor JA, Malik M, Moran S, DeAngelis A, Driggers P, Afrin S, Borahay M, Catherino WH. Simvastatin induces degradation of the extracellular matrix in human leiomyomata: novel in vitro, in vivo, and patient level evidence of matrix metalloproteinase involvement. F S Sci. 2024 Feb;5(1):80-91. doi: 10.1016/j.xfss.2023.11.005. Epub 2023 Dec 2.
PubMed 38043603
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded, Phase II, Randomized Control Trial to Study the Effects of Simvastatin in Patients With Uterine Leiomyoma
- ClinicalTrials.gov ID
- NCT03400826
- Acronym / sponsor ID
- IRB00149869
- Conditions
- Fibroid Uterus, Fibroid Tumor, Leiomyoma, Fibromyoma, Leiomyoma, Uterine
- Keywords
- simvastatin, fibroids, medical management, uterine fibroids, leiomyoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 17 Jan 2018 (actual)
- 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 study aims to study the effect of simvastatin on the size of uterine fibroids.
Detailed description
The study is a phase II double blinded clinical trial to determine feasibility, safety and preliminary clinical efficacy of simvastatin to reduce leiomyoma size. Women with symptomatic fibroids planned to undergo surgical management for fibroids such as hysterectomy or myomectomy will be screened for participation. The eligible women will undergo pre-study evaluation to ascertain study eligibility.The study will enroll 60 participants in total, half will receive simvastatin and the other half will receive a placebo. The study drug and placebo will be an add on to the participants ongoing medical management of fibroids until surgery. The participants will be monitored at intervals for the effect of the drug on fibroid size and symptoms using ultrasound and quality of life questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Simvastatin 40mgThe 30 participants randomized in this group will intake Simvastatin 40mg / day of orally at the same time in the evening, every day for the study duration of 12 weeks prior to undergoing hysterectomy/ myomectomy. The fibroid samples will be collected after the surgery to evaluate the effects of the study medication on the fibroid tissue. |
| Placebo Group | Placebo comparator | Drug: Placebo 40 mgThe 30 participants randomized in this group will intake Placebo 40mg / day orally at the same time in the evening every day for the study duration of 12 weeks prior to undergoing hysterectomy/ myomectomy. The fibroid samples will be collected after the surgery to evaluate the effects of the study medication on the fibroid tissue. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Signed informed written consent.
- Gender: female.
- Age: 18-55 years at time of signing consent.
- BMI of subjects: < 45 kg/m2.
- Uterine fibroids:
Key exclusion criteria (17 listed)
- Pregnancy or lactation.
- Previous or current uterine, cervical or ovarian cancer.
- Current endometrial hyperplasia or history of atypical endometrial hyperplasia. Endometrial biopsy will be done during screening (if not done within last 12 months).
- Suspicion of leiomyosarcoma.
- Recent rapid growth of fibroids (i.e. doubling in size within 1-6 months period).
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 |
|---|---|---|
| Simvastatin 40mgAlso: SimvastatinThe Treatment Group subjects will orally intake encapsulated Simvastatin 40 mg tablets daily for the 12 weeks duration with water in the evening. | Drug | Treatment Group |
| Placebo 40 mgAlso: Starch 1500 encapsulatedThe Placebo group will orally intake encapsulated Starch 1500, 40 mg Placebo for 12 weeks duration with water in the evening. | Drug | Placebo Group |
Primary outcome
Change in Tumor size volume pre and post study intervention
Time frame: Change from baseline to 12 weeks post intervention
Tumor size measured by ultrasound imaging comparing tumor volume using ultrasound imaging. The volume will be reported in Centimeter cubes. The largest radius of the tumor will be used to calculate the volume, this will be measured in centimeters.
3 secondary outcomes
Clinical symptom improvement as determined by the Uterine Fibroid Symptom and Health Related Quality of Life Questionnaire.
Time frame: At visit 1 (Screening), At visit 2 (start of the study drug intake), visit 3 (6 weeks after start of the study drug), visit 4( 12 weeks after start of the study drug), and follow up visit at 2 and 6 weeks post hysterectomy
Adherence to the recommended treatment dosing
Time frame: At Visit 3 (6 weeks after start of study drug), and Visit 4 (12 weeks after start of the study drug)
Subject retention
Time frame: At visit 2 (start of the study drug intake), visit 3 (6 weeks after start of the study drug), visit 4 (12 weeks after start of the study drug), and follow up visit at 2 and 6 weeks post hysterectomy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Derived from this study: PubMed 38043603Britten J, Roura-Monllor JA, Malik M, Moran S, DeAngelis A, Driggers P, Afrin S, Borahay M, Catherino WH. Simvastatin induces degradation of the extracellular matrix in human leiomyomata: novel in vitro, in vivo, and patient level evidence of matrix metalloproteinase involvement. F S Sci. 2024 Feb;5(1):80-91. doi: 10.1016/j.xfss.2023.11.005. Epub 2023 Dec 2.
- Individual participant dataSharing planned: No
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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.
Mostafa Borahay, MD, PhD principal investigator
Johsn Hopkins School Of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Simvastatin 40mg in people with Fibroid Uterus and Fibroid Tumor, run by Johns Hopkins University 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 19 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in Tumor size volume pre and post study intervention (time frame: Change from baseline to 12 weeks post intervention). 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 NCT03400826, 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 21 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.