Novel MRI Strategies as a Non-invasive Biomarker in Women With Uterine Fibroids
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|ClinicalTrials.gov Identifier: NCT00746031|
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : October 25, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Fibroid Leiomyoma||Drug: GnRH analogue (Zoladex) Drug: GnRH antagonist-Cetrorelix||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Novel Magnetic Resonance Imaging Strategies as a Non-invasive Biomarker of Vascular and Extracellular Matrix Morphology in Women With Uterine Fibroids.|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
Active Comparator: 1
Drug: GnRH analogue (Zoladex)
3.6mg subcutaneous implant. Monthly doses x 3.
Active Comparator: 2
GnRH antagonist plus GnRH analogue
Drug: GnRH analogue (Zoladex)
3.6mg subcutaneous implant. Monthly doses x 3.Drug: GnRH antagonist-Cetrorelix
Subcutaneous injection 3mg x3 over 7 days
Other Name: Cetrotide
|No Intervention: 3|
- Uterine and fibroid volume [ Time Frame: 2010 ]
- Uterine vascular perfusion, vasculature and extracellular matrix (ECM)content of fibroids. [ Time Frame: 2010 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746031
|University of Edinburgh/ Royal Infirmary of Edinburgh|
|Edinburgh, United Kingdom, EH16 4SA|
|Principal Investigator:||HILARY OD CRITCHLEY, MBChB;MD;FRCOG||University of Edinburgh|