Research into effectiveness and costs concerning the use of (vaginally administered) oestrogen before and after vaginal prolapse surgery, in women after menopause.

Phase 1

• Conditions: Pelvic organ prolapse; MedDRA version: 21.1 Level: PT Classification code 10046940 Term: Vaginal prolapse System Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2017-003144-21-NL
• Lead Sponsor: Board of Directors, Academic Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-28
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 300

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified