Effects of Simvastatin on Uterine Leiomyoma Size
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorJohns Hopkins University
About this trial
The study aims to study the effect of simvastatin on the size of uterine fibroids.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed written consent.
Gender: female.
Age: 18-55 years at time of signing consent.
BMI of subjects: < 45 kg/m2.
Disqualifiers
Pregnancy or lactation.
Previous or current uterine, cervical or ovarian cancer.
Current endometrial hyperplasia or history of atypical endometrial hyperplasia. Endometrial biopsy will be done during screening (if not done within last 12 months).
Suspicion of leiomyosarcoma.
Trial design
Design model
Parallel
Treatments tested in this trial
Simvastatin 40mg
DrugThe Treatment Group subjects will orally intake encapsulated Simvastatin 40 mg tablets daily for the 12 weeks duration with water in the evening.
Placebo 40 mg
DrugThe Placebo group will orally intake encapsulated Starch 1500, 40 mg Placebo for 12 weeks duration with water in the evening.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Treatment GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Tumor size volume pre and post study intervention
Tumor size measured by ultrasound imaging comparing tumor volume using ultrasound imaging. The volume will be reported in Centimeter cubes. The largest radius of the tumor will be used to calculate the volume, this will be measured in centimeters.
Time frame
Change from baseline to 12 weeks post interventionSecondary outcomes
1
Clinical symptom improvement as determined by the Uterine Fibroid Symptom and Health Related Quality of Life Questionnaire.
The questionnaire used is the Uterine Fibroid Symptom and Health Related Quality of Life Questionnaire. This questionnaire is an effective and validated tool for detecting differences in symptom severity and health-related quality of life among patients with uterine fibroids. The scale for this questionnaire denotes symptom severity with lowest and highest possible scores of 8 and 40 respectively. Higher scores indicate greater severity of symptoms.
Time frame
At visit 1 (Screening), At visit 2 (start of the study drug intake), visit 3 (6 weeks after start of the study drug), visit 4( 12 weeks after start of the study drug), and follow up visit at 2 and 6 weeks post hysterectomy2
Adherence to the recommended treatment dosing
Based on review of patient diaries and counting of left over medications bought back by the subject. This will be reported as an overall percentage.
Time frame
At Visit 3 (6 weeks after start of study drug), and Visit 4 (12 weeks after start of the study drug)3
Subject retention
Based on presence at follow up visits to the study site. This will be determined as a simple percentage of subjects that stay in the study until the last visit.
Time frame
At visit 2 (start of the study drug intake), visit 3 (6 weeks after start of the study drug), visit 4 (12 weeks after start of the study drug), and follow up visit at 2 and 6 weeks post hysterectomy.Other outcomes
1
Adverse events reporting by organ systems
Based on patient reporting and study team evaluation utilizing CTCAE v.4
Time frame
At visit 2 (start of the study drug intake), visit 3 (6 weeks after start of the study drug), visit 4 (12 weeks after start of the study drug), and follow up visit at 2 and 6 weeks post hysterectomy.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov