EUCTR2017-003144-21-NLActive, not recruitingPhase 1
Cost-effectiveness of perioperative vaginally administered oestrogen in postmenopausal women undergoing prolapse surgery. - EVA trial
Board of Directors, Academic Medical Centre0 sites300 target enrollmentStarted: February 28, 2018Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •- Postmenopausal women (>1 year amenorrhoea) with a minimum age of 18 years old
- •- Pelvic organ prolapse; POP Quantification stage 2 or higher
- •- Women that will undergo primary POP surgery with native tissue repair; including at least anterior OR posterior vaginal wall repair.
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
Exclusion Criteria
- •- Previous POP surgery in concerning compartment
- •- Prolapse repair using mesh
- •- Current vaginal infection
- •- Use of oestrogens in the past 12 months
- •- Contraindication for use of topical oestrogen
- •- Known, past or suspected oestrogen-dependent malignant tumours (e.g. breast cancer, endometrial cancer);
- •- Insufficient knowledge or understanding of the Dutch language
Investigators
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