Obtaining uterine stem cells from postmenopausal women undergoing hysterectomy.
- Conditions
- endometrial stem cells in postmenopausal womenReproductive Health and Childbirth - Menstruation and menopause
- Registration Number
- ACTRN12610000563066
- Lead Sponsor
- Professor CAroline Gargett
- Brief Summary
This phase IV clinical trial showed that endometrial mesenchymal stem cells could be harvested from postmenopausal endometrium 8 weeks after women took 2 mg Progynova (estrogen) daily by tablet to regenerate their thin endometrium. This means that postmenopausal women who have no contraindication for taking estrogen can use their endometrial mesenchymal stem cells for a cell based therapy for pelvic organ prolapse we are developing.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 15
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.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method