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

NCT ID: NCT00746031

Last Updated: 2010-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Fibroid Leiomyoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

GnRH analogue-Zoladex

Group Type ACTIVE_COMPARATOR

GnRH analogue (Zoladex)

Intervention Type DRUG

3.6mg subcutaneous implant. Monthly doses x 3.

2

GnRH antagonist plus GnRH analogue

Group Type ACTIVE_COMPARATOR

GnRH analogue (Zoladex)

Intervention Type DRUG

3.6mg subcutaneous implant. Monthly doses x 3.

GnRH antagonist-Cetrorelix

Intervention Type DRUG

Subcutaneous injection 3mg x3 over 7 days

3

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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GnRH analogue (Zoladex)

3.6mg subcutaneous implant. Monthly doses x 3.

Intervention Type DRUG

GnRH antagonist-Cetrorelix

Subcutaneous injection 3mg x3 over 7 days

Intervention Type DRUG

Other Intervention Names

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Cetrotide

Eligibility Criteria

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Inclusion Criteria

* Age\>18 years
* Scheduled for hysterectomy with a fibroid uterus
* At least one intramural non-pedunculated, submucosal or subserous fibroid(\>2cm) or multiple small fibroids (uterine volume\>200cm3)
* Ability to understand and willingness to sign consent form
* Normal smear within 3 years

Exclusion Criteria

* Pregnant or lactating
* Contra indication to MRI
* Unable to tolerate supine position
* Diabetes and/or renal or hepatic impairment
* Contra indication to any of the study medications including gadolinium, MRI contrast
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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NHS Lothian

OTHER_GOV

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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UNIVERSITY OF EDINBURGH

Principal Investigators

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HILARY OD CRITCHLEY, MBChB;MD;FRCOG

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

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University of Edinburgh/ Royal Infirmary of Edinburgh

Edinburgh, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 24608161 (View on PubMed)

Other Identifiers

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REC number 08/MRE00/30

Identifier Type: -

Identifier Source: org_study_id