PREOPERATIVE LOCALLY APPLIED OESTROGEN IN POSTMENOPAUSAL WOMEN WITH PELVIC ORGAN PROLAPSE: INFLUENCE ON SUBJECTIVE AND OBJECTIVE PARAMETERS
- Conditions
- Pelvic organ prolapseTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2016-000410-30-AT
- Lead Sponsor
- Medical University of Vienna, Department of Obstetrics and Gynecology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 120
•Postmenopausal women
•Able to read, understand and sign informed consent
•Able to apply a vaginal cream
•Symptomatic pelvic organ prolapse
•Planned and indicated for surgery
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary Objective<br>•To demonstrate treatment efficacy of preoperative vaginally administered oestrogen in postmenopausal women with symptomatic pelvic organ prolapse in comparison to placebo, measured by a subjective questionnaire <br>;Secondary Objective: Secondary Objectives<br>•To assess effect of preoperative vaginally administered oestrogen on postoperative outcome in comparison to placebo<br>•To assess differences in tissue operability between the two groups assessed by the surgeon<br>•To assess possible differences regarding subjective and objective outcome parameters between intervention and placebo-group 3 months after operation<br>;Primary end point(s): Improvement of prolapse specific symptoms after preoperative treatment;Timepoint(s) of evaluation of this end point: after treatment of 6 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Questionnaire domaine POP (POP score) at 3 months follow up, Other domains of the questionnaire (xxxxx) (baseline, 6 weeks, 3 months), POP-Q Score (baseline, 6 weeks, 3 months), postoperative variables;Timepoint(s) of evaluation of this end point: 6 weeks and 3 months after treatment