Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients
Randomized, Blinded Trial Comparing Vaginal Estrogens on Pelvic Organ Prolapse Patients
2 other identifiers
interventional
69
0 countries
N/A
Brief Summary
To evaluate the difference of three vaginal estrogens creams comparative with placebo on improvement of hormonal cytology, local and systemic climacteric complaints, as well as its endometrial security.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2013
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 26, 2016
CompletedFirst Submitted
Initial submission to the registry
January 20, 2017
CompletedFirst Posted
Study publicly available on registry
January 26, 2017
CompletedMay 1, 2019
April 1, 2019
3.1 years
January 20, 2017
April 29, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Evaluate the histopathological effects on endometrium after each treatment
Compare the histopathological results after treatment on each group and among each other
48 days
Compare the endometrial thickness measured by ultrassound after each treatment
Compare the endometrial ultrasound measurement before and after treatment in each group, and among each other
48 days
Secondary Outcomes (2)
Evaluate the changes of maturation index (Meisels Index) after each treatement
48 days
Evaluate the changes on climacteric complaints after each treatment
48 days
Study Arms (4)
Conjugated Estrogen Group
ACTIVE COMPARATORuse of 1 gram per day
Promestriene Group
ACTIVE COMPARATORuse of 1 gram per day
Estriol Group
ACTIVE COMPARATORuse of 1 gram per day
Vaginal Moisturizer Cream
PLACEBO COMPARATORuse of 1 gram per day
Interventions
use of 1 gram per day
use of 1 gram per day
use of 1 gram per day
use of 1 gram per day
Eligibility Criteria
You may qualify if:
- post menopause women
- normal oncotic cytology and mammogram
- any grade of pelvic organ prolapse with surgery indication and ultrasound with endometrium measure less than 5 mm
You may not qualify if:
- vaginal bleeding
- hormonal replacement on the past three months
- renal or hepatic desease
- porfiria
- past venous thromboembolism; ulcerated prolapse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2.
PMID: 23985562RESULTTaithongchai A, Johnson EE, Ismail SI, Barron-Millar E, Kernohan A, Thakar R. Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women. Cochrane Database Syst Rev. 2023 Jul 11;7(7):CD014592. doi: 10.1002/14651858.CD014592.pub2.
PMID: 37431855DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
January 20, 2017
First Posted
January 26, 2017
Study Start
November 26, 2013
Primary Completion
December 20, 2016
Study Completion
December 26, 2016
Last Updated
May 1, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will share