Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000563066
Ethics application status
Approved
Date submitted
9/07/2010
Date registered
13/07/2010
Date last updated
11/02/2021
Date data sharing statement initially provided
11/02/2021
Date results provided
11/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Obtaining uterine stem cells from postmenopausal women undergoing hysterectomy.
Scientific title
Estrogen treatment to induce endometrial regeneration in postmenopausal women scheduled to undergo hysterectomy, to obtain endometrial mesenchymal stem cells.
Secondary ID [1] 252188 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
endometrial stem cells in postmenopausal women 257724 0
Condition category
Condition code
Reproductive Health and Childbirth 257896 257896 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a one treatment arm study, where Estradiol valerate, will be given as a daily oral dose of a 1 or 2 mg tablet for 8 weeks prior to scheduled hysterectomy. An initial trial of 5 patients with 1 mg dose will be undertaken to determine if this low dose is sufficient to regenerate the endometrium. If inadequate, the 2 mg dose will be used.

If the patient is already on hormone replacement therapy (ie 1 mg oral estradiol valerate, 1 mg oral micronized estradiol, 0.325 mg oral conjugated equine estrogens), the progestin component will be stopped and the patient will continue with the original estrogen alone for 8 weeks prior to hysterectomy
Intervention code [1] 256780 0
Treatment: Other
Intervention code [2] 256791 0
Treatment: Drugs
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258758 0
isolation of endometrial mesenchymal stem cells from an endometrial biopsy taken during surgery just prior to the hysterectomy
Timepoint [1] 258758 0
8 weeks after commencement of estradiol valerate treatment
Secondary outcome [1] 264816 0
nil
Timepoint [1] 264816 0
nil

Eligibility
Key inclusion criteria
Postmenopausal women who have not had a period for >12 months who are scheduled to undergo hysterectomy for treatment of their underlying clinical condition, usually for pelvic organ prolapse but may include other indications (eg fibroids, menorrhagia).

Women already on hormone replacement therapy will be recruited and if appropriate, the estrogen component will be changed to estradiol valerate without a progestogen.
Minimum age
45 Years
Maximum age
69 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Undiagnosed abnormal genital bleeding.
Known, suspected, or history of cancer of the breast..
Known or suspected estrogen-dependent neoplasia.
Current or past history of deep vein thrombosis, pulmonary embolism, or a known coagulopathy.a history of these conditions.
Active or recent (within the past year) arterial thromboembolic disease (for example, stroke, myocardial infarction); uncontrolled hypertension.
Liver dysfunction or disease.
Known hypersensitivity to any of the ingredients in Progynova.
Known or suspected pregnancy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Dr Anna Rosamilia will identify potential eligible participants seeking treatment for their urogynaecogical problem at Southern Health, Cabrini or Waverley Private Hospitals. A urogynaecologist is required for obtaining participation as it is necessary for her to diagnose that the patient requires a hysterectomy as part of the treatment for her clinical condition. Furthermore, a gynaecologist is required to determine the suitability of potential participants with respect to exclusion criteria for treatment with estradiol valerate (Progynova) and subsequent monitoring of these participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
nil
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/08/2010
Actual
24/01/2011
Date of last participant enrolment
Anticipated
Actual
21/08/2013
Date of last data collection
Anticipated
Actual
16/10/2013
Sample size
Target
30
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 257268 0
Government body
Name [1] 257268 0
This trial is now funded by the NHMRC
Country [1] 257268 0
Australia
Primary sponsor type
Individual
Name
Professor CAroline Gargett
Address
Monash University Department of Obstetrics and Gynaecology and The Ritchie Centre, MIMR-PHI Institute of Medical REsearch 27-31 Wright Street Clayton, victoria, 3168
Country
Australia
Secondary sponsor category [1] 256512 0
None
Name [1] 256512 0
Address [1] 256512 0
Country [1] 256512 0
Other collaborator category [1] 251379 0
Government body
Name [1] 251379 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Address [1] 251379 0
Biomaterials and Regenerative Medicine/Molecular and Health Technologies
Bayview Ave
Clayton, Victoria, 3168
Country [1] 251379 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259290 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 259290 0
Monash Medical Centre
246 Clayton Road
Clayton, Vic 3168
Ethics committee country [1] 259290 0
Australia
Date submitted for ethics approval [1] 259290 0
28/04/2010
Approval date [1] 259290 0
16/07/2010
Ethics approval number [1] 259290 0
10103B

Summary
Brief summary
This phase 4 clinical trial is to determine whether estradiol valerate (1 or 2 mg daily for 8 weeks prior to hysterectomy) will regenerate the endometrium from postmenopausal women sufficiently to enable endometrial mesenchymal stem cells to be isolated from a biopsy taken during surgery just prior to surgical removal of the uterus. It is a proof-of-principle study to determine if endometrial stem cells can be isolated from postmenopausal women for potential autologous use in tissue engineering as a construct for pelvic organ prolapse repair surgery.
Trial website
nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31380 0
Prof Caroline Gargett
Address 31380 0
The Ritchie Centre, Hudson Institute of Medical Research,
27-31 Wright Street, Clayton, Victoria, 3168
Country 31380 0
Australia
Phone 31380 0
+61 3 8572 2795
Fax 31380 0
+61 3 9594 7439
Email 31380 0
caroline.gargett@monsh.edu
Contact person for public queries
Name 14627 0
Prof Caroline Gargett
Address 14627 0
The Ritchie Centre, Hudson Institute of Medical Research 27-31 Wright St Clayton, Vic 3168
Country 14627 0
Australia
Phone 14627 0
+61 3 8572 2795
Fax 14627 0
+61 3 9594 7439
Email 14627 0
caroline.gargett@monash.edu
Contact person for scientific queries
Name 5555 0
Prof Caroline Gargett
Address 5555 0
The Ritchie Centre, Hudson Institute of Medical Research, 27-31 Wright street, Clayton, Victoria 3168
Country 5555 0
Australia
Phone 5555 0
+61 3 8572 2795
Fax 5555 0
+61 3 9594 7439
Email 5555 0
caroline.gargett@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a scientific study that is still in development for a potential future therapy for treating pelvic organ prolapse. It did not test a cell-therapy in women. It simply enabled us to show proof of principle that we could harvest the cells from postmenopausal women whose endometrium is atrophic.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.