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HMG-CoA reductase inhibitor

Simvastatin for Uterine Fibroids

Q: Is this particular trial a groundbreaking innovation?

Presently, 39 ongoing clinical trials related to Simvastatin 40mg are being conducted in 240 cities and 31 countries. These investigations began with a 2005 Merck Sharp &#x26; Dohme LLC-sponsored Phase 4 trial that examined the drug's effects on 80 participants. Since then, 312 studies have been undertaken on this medication.

Q: When is Simvastatin 40mg typically utilized by doctors?

Simvastatin 40mg can be leveraged to manage <a href="https://www.withpower.com/clinical-trials/cholesterol">cholesterol</a> levels, <a href="https://www.withpower.com/clinical-trials/diabetes">diabetes</a> mellitus and reduce the risk of <a href="https://www.withpower.com/clinical-trials/cardiovascular">cardiovascular</a> events.

Q: Has there been any additional research regarding Simvastatin 40mg?

As of now, the world has 39 active studies dedicated to Simvastatin 40mg. Of those trials, 8 are in Phase 3. Pontyclun, Wales is a primary research site for this medication; however there are 482 other test centres worldwide conducting trials as well.

Phase 2

Recruiting

Led By Mostafa Borahay, MD, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least one fibroid of diameter > 3cm

Gender: female

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at visit 3 (6 weeks after start of study drug), and visit 4 (12 weeks after start of the study drug)

Awards & highlights

Study Summary

This trial will study whether the drug simvastatin can help to shrink uterine fibroids.

Who is the study for?

Women aged 18-55 with uterine fibroids causing heavy bleeding and pelvic pain are eligible for this trial. They must have at least one fibroid larger than 3cm, be using contraception, and not be pregnant or breastfeeding. Exclusions include allergies to simvastatin, liver disease, other cancers, menopause status, or currently in another study.Check my eligibility

What is being tested?

The trial is testing whether Simvastatin (40mg), a medication typically used to lower cholesterol, can reduce the size of uterine fibroids compared to a placebo. Participants will randomly receive either the drug or an inactive substance.See study design

What are the potential side effects?

Simvastatin may cause muscle pain or weakness (myopathy), liver issues (elevated liver enzymes), digestive problems like constipation or nausea, headache, and increased risk of diabetes. It's important to monitor for any unusual symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a fibroid larger than 3cm.

Select...

I am female.

Select...

My condition involves the inner or middle layers of a wall.

Select...

I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Tumor size volume pre and post study intervention

Secondary outcome measures

Adherence to the recommended treatment dosing

Clinical symptom improvement as determined by the Uterine Fibroid Symptom and Health Related Quality of Life Questionnaire.

Subject retention

Other outcome measures

Adverse events reporting by organ systems

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment GroupExperimental Treatment1 Intervention

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.

Group II: Placebo GroupPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Simvastatin

FDA approved

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,260 Previous Clinical Trials

14,820,720 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,479 Total Patients Enrolled

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,964 Previous Clinical Trials

2,674,670 Total Patients Enrolled

Media Library

Simvastatin (HMG-CoA reductase inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03400826 — Phase 2

Fibroid Research Study Groups: Treatment Group, Placebo Group

Fibroid Clinical Trial 2023: Simvastatin Highlights & Side Effects. Trial Name: NCT03400826 — Phase 2

Simvastatin (HMG-CoA reductase inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03400826 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are participating in this medical experiment?

"Affirmative. According to clinicaltrials.gov, this experiment is still seeking participants after being first posted on August 20th 2018 and edited most recently on August 4th 2022. 60 volunteers are needed at a single trial site."

Answered by AI

Is this clinical research still open to participants?

"Clinicaltrials.gov lists this clinical trial as presently seeking participants; it was first posted on the 20th of August 2018 and has most recently been updated on the 4th of August 2022."

Answered by AI

Is Simvastatin 40mg a secure pharmaceutical option for people?

"There is clinical evidence suggesting simvastatin 40mg's safety, thus our team at Power appraised the drug with a score of 2. Notably, this phase two trial does not include any data that verifies its efficacy."

Answered by AI

Does this investigation permit minors to participate?

"This study is designed to recruit patient between the ages of 18 and 55. Those who fall outside this age range may still be able to participate in two clinical trials for people under 18 or fifty-two studies for those over 65."

Answered by AI

Could I be a participant in this research study?

"This clinical trial seeks 60 individuals aged 18-55, who have leiomyoma and meet the following criteria: Utilizing double protection for menstrual bleeding, feeling of 'gushing' or 'flooding', at least one fibroid > 3cm in diameter, signed informed written consent, BMI < 45 kg/m2., any number of fibroids located submucosal or intramural."

Answered by AI

Is this particular trial a groundbreaking innovation?

"Presently, 39 ongoing clinical trials related to Simvastatin 40mg are being conducted in 240 cities and 31 countries. These investigations began with a 2005 Merck Sharp & Dohme LLC-sponsored Phase 4 trial that examined the drug's effects on 80 participants. Since then, 312 studies have been undertaken on this medication."

Answered by AI

When is Simvastatin 40mg typically utilized by doctors?

"Simvastatin 40mg can be leveraged to manage cholesterol levels, diabetes mellitus and reduce the risk of cardiovascular events."

Answered by AI

Has there been any additional research regarding Simvastatin 40mg?

"As of now, the world has 39 active studies dedicated to Simvastatin 40mg. Of those trials, 8 are in Phase 3. Pontyclun, Wales is a primary research site for this medication; however there are 482 other test centres worldwide conducting trials as well."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Simvastatin on Uterine Leiomyoma Size

2018. "Effects of Simvastatin on Uterine Leiomyoma Size". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03400826.

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