RECRUITING

Effects of Simvastatin on Uterine Leiomyoma Size

Conditions

Fibroid Uterus Fibroid Tumor Leiomyoma Fibromyoma Leiomyoma, Uterine simvastatin fibroids medical management uterine fibroids

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study aims to study the effect of simvastatin on the size of uterine fibroids.

Official Title

A Double-blinded, Phase II, Randomized Control Trial to Study the Effects of Simvastatin in Patients With Uterine Leiomyoma

Quick Facts

Study Start:2018-08-20

Study Completion:2025-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03400826

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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). * 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.	* 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). * 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.

Inclusion Criteria

Exclusion Criteria

* 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).
* 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.

* 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).
* 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.

Contacts and Locations

Study Contact

Mostafa Borahay, MD, PhD

CONTACT

(410) 550-0337

mboraha1@jhmi.edu

Principal Investigator

Mostafa Borahay, MD, PhD

PRINCIPAL_INVESTIGATOR

Johsn Hopkins School Of Medicine

Study Locations (Sites)

Johns Hopkins Hospital

Baltimore, Maryland, 21218

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Mostafa Borahay, MD, PhD, PRINCIPAL_INVESTIGATOR, Johsn Hopkins School Of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-08-20

Study Completion Date2025-07-31

Study Record Updates

Study Start Date2018-08-20

Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

simvastatin
fibroids
medical management
uterine fibroids
leiomyoma

Additional Relevant MeSH Terms

Fibroid Uterus
Fibroid Tumor
Leiomyoma
Fibromyoma
Leiomyoma, Uterine