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

Status

Completed

Phase

Phase 4

Enrollment

30 participants (actual)

Sponsor

University of Edinburgh · Other

Design

Randomized · Open label (no masking)

Countries

1 country

United Kingdom

Start

Dec 2008

Primary completion

Sept 2010

Completion

Sept 2010

First posted

3 Sept 2008 (estimated)

Last update posted

25 Oct 2010 (estimated)

Conditions

Fibroid · Leiomyoma

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.

• Active comparator

  1

  GnRH analogue-Zoladex

• Active comparator

  2

  GnRH antagonist plus GnRH analogue

• No intervention

  3

1. Uterine and fibroid volume

   Time frame · 2010