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The Effect of Simvastatin on Uterine Leiomyoma Development and Growth in Infertile Women

NCT03134157 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-10-06

No results posted yet for this study

Summary

Uterine leiomyomas with an estimated incidence of 50%-80% are the most common tumors of female reproductive system. Statins as a HMG-CoA reductase inhibitors inhibit the mevalonate pathway of cholesterol synthesis, thus have been known as a group of drugs used for treatment of hypercholesterolemia. Statins inhibit proliferation of several cell types including vascular smooth muscle, hepatocytes and other cell types. Leiomyomas are benign uterine tumors characterized by smooth muscle proliferation and excessive deposition of extracellular matrix. In the present study we aim to evaluate the effect of simvastatin on uterine leiomyoma development and growth.

Conditions

Interventions

DRUG

oral drug and vaginal placebo

prescription of simvastatin 40 mg orally+ vaginal placebo every day for 3 months.

DRUG

oral drug and oral placebo

prescription of simvastatin 40 mg orally+ oral placebo every day for 3 months.

DRUG

Vaginal placebo+ oral placebo

prescription of Vaginal placebo + oral placebo every day for 3 months.

Sponsors & Collaborators

  • Royan Institute

    lead OTHER_GOV

Principal Investigators

  • Mahnaz Ashrafi, MD · ) Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

  • Hamid Gourabi, PhD · Head of Royan Institute

  • Firoozeh Ahmadi, MD · ) Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

  • Nadia Jahangiri, MSc · ) Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2021-06-14
Completion
2021-09-14

Countries

  • Iran

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03134157 on ClinicalTrials.gov