Core Outcome Measures in Effectiveness Trials

Variation in menopausal vaginal symptoms outcomes in clinical trials: A systematic review.

General Information

There is substantial variation in reporting menopausal vaginal symptoms related outcomes from interventional studies. The lack of consistency negatively impacts evidence synthesis and summary size estimation. Our objective is to systematically review menopausal vaginal symptom related outcomes reported in randomized controlled trials of treatment interventions. Our database search included PubMed, Cochrane Database and SCOPUS for all RCTs involving interventions for vaginal symptoms of menopause.

The International COMMA (Core Outcomes in Menopause) Consortium
Monica Christmas MD, Principal Investigator, University of Chicago, Chicago IL
Bonnie , Medical Student, University of Chicago, Chicago, IL
Stamatina Iliodromiti, Women's Health Division, Blizard Institute, Queen Mary University London, London UK
Martha Hickey. Department of Obstetrics and Gynecology, University of Melbourne and The Royal Women's Hospital, Victoria Australia - superivisor

Further Study Information

Current Stage:
2018 - July 2019
Funding source(s):

Health Area

Disease Category

Disease Name

Target Population

Age Range


Nature / type of Intervention


Systematic review

We will include all RCTs of intervention studies with either a primary or secondary outcome of female menopausal vaginal symptoms and a sample size of at least 20 women per study arm. We will exclude quasi-randomized studies, secondary analyses of previously published RCTs, conference abstracts of RCTs, observational, analytical, or diagnostic studies, feasibility or pilot studies and studies not in English.

Stakeholders Involved


Study Type

Systematic review of outcomes measured in trials

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