Novel MRI Strategies as a Non-invasive Biomarker in Women With Uterine Fibroids

Phase 4

Completed

• Conditions: Fibroid; Leiomyoma
• Interventions: Drug: GnRH analogue (Zoladex); Drug: GnRH antagonist-Cetrorelix

• Registration Number: NCT00746031
• Lead Sponsor: University of Edinburgh

Brief Summary

Fibroids are present in up to 80% of women of reproductive age. Associated heavy menstrual bleeding is often an indication for surgery. At present there are no long-term medical treatments for fibroids. There is an unmet need for a pharmacologic agent able to reduce excessive bleeding and other symptoms associated with increased uterine volume, which could prevent or significantly delay surgery without causing significant unwanted hypoestrogenic side effects and allow preservation of fertility.

The purpose of this study is to investigate and validate novel MR imaging as a non-invasive biomarker for monitoring responses to medical interventions aimed at reduction of excessive menstrual bleeding and decrease in uterine/ fibroid volume. MR imaging is non-invasive, does not involve ionizing radiation and new techniques have the potential to resolve tissue detail to near cellular level.

The investigators are aiming to establish the feasibility and reproducibility of novel MR imaging techniques in the evaluation of treatment response in women with fibroids and to provide mechanistic information on whether the reduction in blood flow of uterine/fibroid vasculature in the shrinkage of fibroids is dependent upon subjects being hypoestrogenic.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-01
• Study First Submitted QC: 2008-09-02
• Study First Posted: 2008-09-03
• Study Start: 2008-12
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-22
• Last Update Posted: 2010-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	GnRH antagonist-Cetrorelix	GnRH antagonist plus GnRH analogue
1	GnRH analogue (Zoladex)	GnRH analogue-Zoladex
2	GnRH analogue (Zoladex)	GnRH antagonist plus GnRH analogue

Primary Outcome Measures

Name	Time	Method
Uterine and fibroid volume	2010

Secondary Outcome Measures

Name	Time	Method
Uterine vascular perfusion, vasculature and extracellular matrix (ECM)content of fibroids.	2010

Trial Locations

Locations (1)

University of Edinburgh/ Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, United Kingdom