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

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ClinicalTrials.gov Identifier: NCT03134157
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Royan Institute

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: oral drug and vaginal placebo Drug: oral drug and oral placebo Drug: Vaginal placebo+ oral placebo Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation the Effect of Simvastatin on Uterine Leiomyoma Development and Growth in Infertile Patients
Actual Study Start Date : August 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
Drug Information available for: Simvastatin

Arm Intervention/treatment
Experimental: Simvastatin and vaginal placebo
The patients with leiomyoma receive simvastatin 40 mg orally+ vaginal placebo will be given every day for 3 months.
Drug: oral drug and vaginal placebo
prescription of simvastatin 40 mg orally+ vaginal placebo every day for 3 months.

Experimental: Simvastatin and oral placebo
The patients with leiomyoma receive simvastatin 40 mg orally+ oral placebo will be given every day for 3 months.
Drug: oral drug and oral placebo
prescription of simvastatin 40 mg orally+ oral placebo every day for 3 months.

Experimental: Vaginal placebo+ oral placebo
The patients with leiomyoma receive Vaginal placebo+ oral placebo every day for 3 months.
Drug: Vaginal placebo+ oral placebo
prescription of Vaginal placebo + oral placebo every day for 3 months.




Primary Outcome Measures :
  1. Uterine fibroid size [ Time Frame: 3 months ]
    Evaluation the size of Uterine fibroid withultrasound.


Secondary Outcome Measures :
  1. Uterine size [ Time Frame: 3months ]
    Evaluation the uterine size with ultrasound.

  2. Plasma concentration of Vitamin D3 [ Time Frame: 3 months ]
    Evaluation the Plasma concentration of Vitamin D3 with blood sampling.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134157


Contacts
Contact: Nasser Aghdami, MD,PhD (+98)23562000 ext 516 nasser.aghdami@royaninstitute.org
Contact: Leila Arab, MD (+98)23562000 ext 414

Locations
Iran, Islamic Republic of
Royan Institute Recruiting
Tehrān, Iran, Islamic Republic of
Contact: Nasser Aghdami, MD,PhD    (+98)2123562000 ext 516    nasser.aghdami@royaninstitute.org   
Contact: Leila Arab, MD    (+98)2123562000 ext 414    Leara91@gmail.com   
Principal Investigator: Firoozeh Ghafari, MD         
Principal Investigator: Elham Amirchaghmaghi, MD,PhD         
Sub-Investigator: Farnaz Akbari, MSc         
Sub-Investigator: Amir Almasi, MD         
Sponsors and Collaborators
Royan Institute
Investigators
Study Director: Mahnaz Ashrafi, MD ) Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: Firoozeh Ahmadi, MD ) Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
Principal Investigator: Nadia Jahangiri, MSc ) Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT03134157     History of Changes
Other Study ID Numbers: Royan-Emb-029
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Royan Institute:
Leiomyoma simvastatin infertility

Additional relevant MeSH terms:
Infertility
Leiomyoma
Myofibroma
Genital Diseases, Male
Genital Diseases, Female
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors