Effects of Simvastatin on Uterine Leiomyoma Size

  • STATUS
    Recruiting
  • End date
    Dec 1, 2024
  • participants needed
    60
  • sponsor
    Johns Hopkins University
Updated on 9 August 2022
hysterectomy
MRI
simvastatin
pelvic pain
menorrhagia
leiomyoma
uterine fibroid
uterine bleeding
pap smear
smear
simvastatin 40 mg
myomectomy
uterine myomectomy
flooding

Summary

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

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.

Details
Condition Fibroid Uterus, Fibroid Tumor, Leiomyoma, Fibromyoma, Leiomyoma, Uterine
Treatment simvastatin 40mg, Placebo 40 mg
Clinical Study IdentifierNCT03400826
SponsorJohns Hopkins University
Last Modified on9 August 2022

Eligibility

Yes No Not Sure

Inclusion 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

Exclusion Criteria

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
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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