Obtaining uterine stem cells from postmenopausal women undergoing hysterectomy.
Estrogen treatment to induce endometrial regeneration in postmenopausal women scheduled to undergo hysterectomy, to obtain endometrial mesenchymal stem cells.
Professor CAroline Gargett
30 participants
Jan 24, 2011
Interventional
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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
Locations(1)
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ACTRN12610000563066