Status:
COMPLETED
Preoperative Oestrogen in Postmenopausal Women With Pelvic Organ Prolapse
Lead Sponsor:
Medical University of Vienna
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Introduction With increasing age the incidence of pelvic organ prolapse (POP) rises and will increase substantially in the future according to forecasting studies. It is possible that oestrogens, alon...
Eligibility Criteria
Inclusion
- Postmenopausal women
- Able to read, understand and sign informed consent
- Able to apply a vaginal cream
- Symptomatic pelvic organ prolapse with planned and indicated prolapse surgical repair
Exclusion
- Suspicion or history of breast cancer or other oestrogen responsive malignancies (endometrial cancer)
- unexplained abnormal vaginal bleeding
- history of deep vein thrombosis
- inherited or acquired blood clotting disorders (eg, APC resistance, Antithrombin III deficiency)
- transient ischaemic attack, myo- cardial infarction or ischaemic heart disease
- Hypersensitivity to oestrogen
- Unable to read and sign informed consent
Key Trial Info
Start Date :
February 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03779633
Start Date
February 2 2017
End Date
August 27 2020
Last Update
November 17 2020
Active Locations (2)
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1
Department of Obstetrics and Gynecology, University of Tulln
Tulln, Austria, 3430
2
Department of General Gynecology and Gynecologic Oncology of the Medical University Vienna
Vienna, Austria, 1090