NCT03134157

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2016

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2021

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

4.9 years

First QC Date

April 26, 2017

Last Update Submit

October 5, 2020

Conditions

Infertility

Keywords

Leiomyoma simvastatin infertility

Outcome Measures

Primary Outcomes (1)

  • Uterine fibroid size

    Evaluation the size of Uterine fibroid withultrasound.

    3 months

Secondary Outcomes (2)

  • Uterine size

    3months

  • Plasma concentration of Vitamin D3

    3 months

Study Arms (3)

Simvastatin and vaginal placebo

EXPERIMENTAL

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

Simvastatin and oral placebo

EXPERIMENTAL

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

Vaginal placebo+ oral placebo

EXPERIMENTAL

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

Drug: Vaginal placebo+ oral placebo

Interventions

oral drug and vaginal placeboDRUG

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

Simvastatin and vaginal placebo
oral drug and oral placeboDRUG

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

Simvastatin and oral placebo
Vaginal placebo+ oral placeboDRUG

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

Vaginal placebo+ oral placebo

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehrān, Iran

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Mahnaz Ashrafi, MD

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

    STUDY DIRECTOR

  • Hamid Gourabi, PhD

    Head of Royan Institute

    STUDY CHAIR

  • Firoozeh Ahmadi, MD

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

    STUDY DIRECTOR

  • Nadia Jahangiri, MSc

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nasser Aghdami, MD,PhD

CONTACT

(+98)23562000nasser.aghdami@royaninstitute.org

Leila Arab, MD

CONTACT

(+98)23562000

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2017

First Posted

April 28, 2017

Study Start

August 1, 2016

Primary Completion

June 14, 2021

Study Completion

September 14, 2021

Last Updated

October 6, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)