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

Primary Purpose

Infertility

Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
oral drug and vaginal placebo
oral drug and oral placebo
Vaginal placebo+ oral placebo
Sponsored by
Royan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Leiomyoma simvastatin infertility

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Royan InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Simvastatin and vaginal placebo

Simvastatin and oral placebo

Vaginal placebo+ oral placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Uterine fibroid size
Evaluation the size of Uterine fibroid withultrasound.

Secondary Outcome Measures

Uterine size
Evaluation the uterine size with ultrasound.
Plasma concentration of Vitamin D3
Evaluation the Plasma concentration of Vitamin D3 with blood sampling.

Full Information

First Posted
April 26, 2017
Last Updated
October 5, 2020
Sponsor
Royan Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03134157
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (Actual)
Primary Completion Date
June 14, 2021 (Anticipated)
Study Completion Date
September 14, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Leiomyoma simvastatin infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Simvastatin and vaginal placebo
Arm Type
Experimental
Arm Description
The patients with leiomyoma receive simvastatin 40 mg orally+ vaginal placebo will be given every day for 3 months.
Arm Title
Simvastatin and oral placebo
Arm Type
Experimental
Arm Description
The patients with leiomyoma receive simvastatin 40 mg orally+ oral placebo will be given every day for 3 months.
Arm Title
Vaginal placebo+ oral placebo
Arm Type
Experimental
Arm Description
The patients with leiomyoma receive Vaginal placebo+ oral placebo every day for 3 months.
Intervention Type
Drug
Intervention Name(s)
oral drug and vaginal placebo
Intervention Description
prescription of simvastatin 40 mg orally+ vaginal placebo every day for 3 months.
Intervention Type
Drug
Intervention Name(s)
oral drug and oral placebo
Intervention Description
prescription of simvastatin 40 mg orally+ oral placebo every day for 3 months.
Intervention Type
Drug
Intervention Name(s)
Vaginal placebo+ oral placebo
Intervention Description
prescription of Vaginal placebo + oral placebo every day for 3 months.
Primary Outcome Measure Information:
Title
Uterine fibroid size
Description
Evaluation the size of Uterine fibroid withultrasound.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Uterine size
Description
Evaluation the uterine size with ultrasound.
Time Frame
3months
Title
Plasma concentration of Vitamin D3
Description
Evaluation the Plasma concentration of Vitamin D3 with blood sampling.
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nasser Aghdami, MD,PhD
Phone
(+98)23562000
Ext
516
Email
nasser.aghdami@royaninstitute.org
First Name & Middle Initial & Last Name or Official Title & Degree
Leila Arab, MD
Phone
(+98)23562000
Ext
414
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahnaz Ashrafi, MD
Organizational Affiliation
) Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hamid Gourabi, PhD
Organizational Affiliation
Head of Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Firoozeh Ahmadi, MD
Organizational Affiliation
) Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nadia Jahangiri, MSc
Organizational Affiliation
) Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehrān
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nasser Aghdami, MD,PhD
Phone
(+98)2123562000
Ext
516
Email
nasser.aghdami@royaninstitute.org
First Name & Middle Initial & Last Name & Degree
Leila Arab, MD
Phone
(+98)2123562000
Ext
414
Email
Leara91@gmail.com
First Name & Middle Initial & Last Name & Degree
Firoozeh Ghafari, MD
First Name & Middle Initial & Last Name & Degree
Elham Amirchaghmaghi, MD,PhD
First Name & Middle Initial & Last Name & Degree
Farnaz Akbari, MSc
First Name & Middle Initial & Last Name & Degree
Amir Almasi, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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