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

Infertility Clinical Trial

Official title:

Evaluation the Effect of Simvastatin on Uterine Leiomyoma Development and Growth in Infertile Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03134157
• Other study ID #: Royan-Emb-029
• Status: Recruiting
• Phase: Phase 3
• Start date: August 2016
• Est. completion date: September 14, 2021

Study information

• Verified date: October 2020
• Source: Royan Institute
• Contact: Nasser Aghdami, MD,PhD
• Phone: (+98)23562000
• Email: nasser.aghdami[@]royaninstitute.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 14, 2021
• Est. primary completion date: June 14, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Leiomyoma

Intervention

Drug:
• oral drug and vaginal placebo
prescription of simvastatin 40 mg orally+ vaginal placebo every day for 3 months.
• oral drug and oral placebo
prescription of simvastatin 40 mg orally+ oral placebo every day for 3 months.
• Vaginal placebo+ oral placebo
prescription of Vaginal placebo + oral placebo every day for 3 months.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uterine fibroid size	Evaluation the size of Uterine fibroid withultrasound.	3 months
Secondary	Uterine size	Evaluation the uterine size with ultrasound.	3months
Secondary	Plasma concentration of Vitamin D3	Evaluation the Plasma concentration of Vitamin D3 with blood sampling.	3 months