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A Single-Arm Clinical Trial Investigating the Feasibility of a Non-Hormonal Vaginal Moisturizer in Hormone-Receptor Positive Postmenopausal Cancer Survivors Experiencing Estrogen Deprivation Symptoms on Vulvovaginal Health
The purpose of this study is to see whether it is feasible to conduct a study to determine if the use of hyaluronic acid (HLA) vaginal gel (HyaloGYN®) improves vulvovaginal health. This study aims to look at whether or not HyaloGYN® is effective in women with a history of hormone receptor positive cancer and experiencing vaginal and/or vulvar symptoms of estrogen deprivation following their breast and endometrial cancer treatment.
Details
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 106 |
| Start date | 2012-11 |
| Completion | 2021-07-21 |
Conditions
- Breast Cancer
- Endometrial Cancer
Interventions
- HLA vaginal gel (HyaloGYN®),
- questionnaires
Primary outcomes
- investigate feasibility of conducting a 12-week HLA treatment regimen — 12-week
a 12-week HLA treatment regimen, as defined by the percentage of women who are evaluable at the 12-week assessment (i.e., women who have completed both baseline and 12-week vaginal and vulvar outcome assessments).
Countries
United States