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| Name | Class |
|---|---|
| NHS Lothian | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | GnRH analogue-Zoladex |
|
| 2 | Active Comparator | GnRH antagonist plus GnRH analogue |
|
| 3 | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GnRH analogue (Zoladex) | Drug | 3.6mg subcutaneous implant. Monthly doses x 3. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Uterine and fibroid volume | 2010 |
| Measure | Description | Time Frame |
|---|---|---|
| Uterine vascular perfusion, vasculature and extracellular matrix (ECM)content of fibroids. | 2010 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HILARY OD CRITCHLEY, MBChB;MD;FRCOG | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Edinburgh/ Royal Infirmary of Edinburgh | Edinburgh | EH16 4SA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24608161 | Derived | Munro KI, Thrippleton MJ, Williams AR, McKillop G, Walker J, Horne AW, Newby DE, Anderson RA, Semple SI, Marshall I, Lewis SC, Millar RP, Bastin ME, Critchley HO. Quantitative serial MRI of the treated fibroid uterus. PLoS One. 2014 Mar 7;9(3):e89809. doi: 10.1371/journal.pone.0089809. eCollection 2014. |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D017273 | Goserelin |
| C062876 | cetrorelix |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| GnRH antagonist-Cetrorelix |
| Drug |
Subcutaneous injection 3mg x3 over 7 days |
|
|
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |