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Clinical Trials/EUCTR2016-000410-30-AT
EUCTR2016-000410-30-AT
Active, not recruiting
Phase 1

PREOPERATIVE LOCALLY APPLIED OESTROGEN IN POSTMENOPAUSAL WOMEN WITH PELVIC ORGAN PROLAPSE: CHANGES IN SUBJECTIVE AND OBJECTIVE OUTCOME: A PROSPECTIVE RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Medical University of Vienna, Department of Obstetrics and Gynecology0 sites120 target enrollmentOctober 19, 2016
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ConditionsPelvic organ prolapseTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
DrugsLinoladiol Estradiol Emulsion

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Pelvic organ prolapse
Sponsor
Medical University of Vienna, Department of Obstetrics and Gynecology
Enrollment
120
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 19, 2016
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Medical University of Vienna, Department of Obstetrics and Gynecology

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

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