Clinical trial NCT03134157: The Effect of Simvastatin on Uterine Leiomyoma Development and Growth in Infertile Women
Official title: Evaluation the Effect of Simvastatin on Uterine Leiomyoma Development and Growth in Infertile Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Infertility
Keywords: Leiomyoma simvastatin infertility
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2017-04-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Uterine fibroid size
timeFrame: 3 months
Secondary outcomes:
measure: Uterine size
timeFrame: 3months
measure: Plasma concentration of Vitamin D3
timeFrame: 3 months
Other outcomes:
Locations:
city: Tehrān
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: ) Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
name: Mahnaz Ashrafi, MD
role: STUDY_DIRECTOR
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: ) Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
name: Firoozeh Ahmadi, MD
role: STUDY_DIRECTOR
affiliation: ) Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
name: Nadia Jahangiri, MSc
role: PRINCIPAL_INVESTIGATOR
References: