Effects of Simvastatin on Uterine Leiomyoma Size (NCT03400826) | Clinical Trial Compass
RecruitingPhase 2
Effects of Simvastatin on Uterine Leiomyoma Size
United States60 participantsStarted 2018-08-20
Plain-language summary
The study aims to study the effect of simvastatin on the size of uterine fibroids.
Who can participate
Age range
18 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Exclus…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Tumor size volume pre and post study intervention
Timeframe: Change from baseline to 12 weeks post intervention