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

NCT ID: NCT03134157

Last Updated: 2020-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2021-09-14

Brief 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.

Detailed Description

The proposal of the present study approved by our institutional review boards and institution's ethical committee, and all participants will sign a written consent before enter to study. All patients will be randomly divided into three groups and will be randomized to receive simvastatin 40 mg orally + vaginal placebo, simvastatin 40 mg vaginally + oral placebo and vaginal placebo + oral placebo for 3 months.

CBC, Lipid profile, kidney & Liver function tests, FBS & hormonal evaluation will be performed before and after the treatment. Ultrasound examination will be performed before and after the treatment for determining of the number, size, and site of the myoma and also size of the uterus.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Simvastatin and vaginal placebo

The patients with leiomyoma receive simvastatin 40 mg orally+ vaginal placebo will be given every day for 3 months.

Group Type: EXPERIMENTAL

oral drug and vaginal placebo

Intervention Type: DRUG

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

Simvastatin and oral placebo

The patients with leiomyoma receive simvastatin 40 mg orally+ oral placebo will be given every day for 3 months.

Group Type: EXPERIMENTAL

oral drug and oral placebo

Intervention Type: DRUG

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

Vaginal placebo+ oral placebo

The patients with leiomyoma receive Vaginal placebo+ oral placebo every day for 3 months.

Group Type: EXPERIMENTAL

Vaginal placebo+ oral placebo

Intervention Type: DRUG

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

Interventions

oral drug and vaginal placebo

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

Intervention Type: DRUG

oral drug and oral placebo

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

Intervention Type: DRUG

Vaginal placebo+ oral placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age between 20-40 years
• Intramural Fibroids confirmed by ultrasound
• Presence of at least one fibroid with size >4 cm or two fibroids with size >3 cm detected by pelvic ultrasound.
• Presence of at least 3 fibroids with size <3 cm and a history of 2 IVF failures.
• Number of fibroids ≤ 5
• BMI>25 Kg/m2

Exclusion Criteria

• Pregnancy
• Hormonal contraception or any hormonal therapy received in the last 3 months
• Alcohol consumption
• Allergic to simvastatin
• Suspicion or diagnosis of cancer
• Signs or symptoms of mental illness, hepatic dysfunction, myopathic syndromes, diabetes mellitus, renal disease, Cardiovascular disease, hypothyroidism, hypotension, neuropathy, lupus and cataract
• Hb ≤ 7
• Taking antifungal medications, Lipid-Lowering medications (gemfibrozil, clofibrate), warfarin, danazol and erythromycin in the last one month.
• Severe male factor
• Severe endometriosis
• Diminished ovarian reserve

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Royan Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahnaz Ashrafi, MD

Role: STUDY_DIRECTOR

) Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

Hamid Gourabi, PhD

Role: STUDY_CHAIR

Head of Royan Institute

Firoozeh Ahmadi, MD

Role: STUDY_DIRECTOR

) Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

Nadia Jahangiri, MSc

Role: PRINCIPAL_INVESTIGATOR

) Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

Locations

Royan Institute

Tehrān, , Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

Nasser Aghdami, MD,PhD

Role: CONTACT

nasser.aghdami@royaninstitute.org

(+98)23562000 ext. 516

Leila Arab, MD

Role: CONTACT

(+98)23562000 ext. 414

Facility Contacts

Nasser Aghdami, MD,PhD

Role: primary

nasser.aghdami@royaninstitute.org

(+98)2123562000 ext. 516

Leila Arab, MD

Role: backup

Leara91@gmail.com

(+98)2123562000 ext. 414

Other Identifiers

Royan-Emb-029

Identifier Type: -

Identifier Source: org_study_id