BridgeMD
New treatment option for Fibroid Uterus
Official title Effects of Simvastatin on Uterine Leiomyoma Size
ClinicalTrials.gov ID: NCT03400826
What this study is testing
What is Simvastatin 40mg?
Simvastatin 40mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for fibroid uterus.
Also referred to as Simvastatin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to study the effect of simvastatin on the size of uterine fibroids.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55, women only
You may be able to join if
- Signed informed written consent.
- Gender: female.
- Age: 18-55 years at time of signing consent.
- BMI of people: \< 45 kg/m2.
- Uterine fibroids:
You likely can't join if
- 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...
- 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).
See the full eligibility criteria
- Signed informed written consent.
- Gender: female.
- Age: 18-55 years at time of signing consent.
- BMI of people: \< 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...
- 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...
- 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...
- Known increased risk or diagnosis of a myopathy.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.