ocal Oestrogen Treatment in Postmenopausal Women Undergoing Pelvic Organ Prolapse Surgery (LOTUS)

Phase 1

• Conditions: Pelvic organ prolapse; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2014-000179-18-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-10
• Study Completion: 2017-09-01
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1.Postmenopausal women
2.Consented to undergo surgical intervention for pelvic organ prolapse
3.Have not received HRT in the last 12 months
4.Willing to be randomised
5.Give written informed consent

Are the trial subjects under 18?
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Previous breast or uterine malignancy or other hormone- dependent neoplasms
2. Genital bleeding of unknown origin
3. Previous thrombo-embolic episodes in relation to oestrogen therapy
4. Women who cannot understand speak or write in English
5. Women known to be allergic to any of the components of vaginal oestrogens
6. Two or more episodes of culture positive UTI in the last 6 months
7. Previous POP surgery
8. Voiding dysfunction(PVR>150ml)
9. Current or previous POP surgery involving mesh

Study & Design

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