NCT00746031

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

Novel Magnetic Resonance Imaging Strategies as a Non-invasive Biomarker of Vascular and Extracellular Matrix Morphology in Women With Uterine Fibroids.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Edinburgh · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibroid
• Leiomyoma

Interventions

Type	Name	Description
DRUG	GnRH analogue (Zoladex)	3.6mg subcutaneous implant. Monthly doses x 3.
DRUG	GnRH antagonist-Cetrorelix	Subcutaneous injection 3mg x3 over 7 days

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2008-09-03
• Last updated: 2010-10-25

Locations

1 site across 1 country: United Kingdom