None listed
Conditions
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.
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 equi
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
Sponsors
Professor CAroline Gargett
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
45 Years to 69 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed