Non-Hormonal Vaginal Moisturizer in Hormone-Receptor Positive Postmenopausal Cancer Survivors Experiencing Estrogen Deprivation Symptoms
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 vaginal health.
This study aims to look at whether or not it is effective in women with a history of hormone receptor positive cancer and experiencing vaginal symptoms of estrogen deprivation following their breast and endometrial cancer treatment.
Other: HLA vaginal gel (HyaloGYN®),
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- investigate feasibility of conducting a 12-week HLA treatment regimen [ Time Frame: 12-week ] [ Designated as safety issue: No ]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 outcome assessments).
- evaluate the effectiveness of Non-hormonal vaginal gel containing hyaluronic acid (HLA)treatment [ Time Frame: 12 weeks post-HLA treatment initiation ] [ Designated as safety issue: No ]as measured by the Vaginal Assessment Composite Score [VAS], vaginal pH and epithelial atrophy)
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: HLA treatment
This is a single arm prospective longitudinal clinical trial investigating the feasibility of a hyaluronic acid (HLA) vaginal gel (HyaloGYN®; Cebert Pharmaceuticals, Inc.; Birmingham, Alabama) to improve estrogen deprivation vaginal health symptoms in post-menopausal women with a history of hormone-receptor positive cancer with estrogen deprivation symptoms of vaginal dryness and discomfort.
Other: HLA vaginal gel (HyaloGYN®),
Each participant will receive a HLA vaginal gel (HyaloGYN®), which is an over-the-counter, colorless gel to be administered as a vaginal gel for hydration and lubrication of the vaginal epithelium for women suffering dryness. Participants will be instructed to insert the HLA gel into the vagina (with applicator) daily for the first 2 weeks, and then 3 times per week for 10 weeks.Participants will also be asked to keep a moisturizer diary. In it they will record the date and time the gel is used. The initial PhD/NP visit and subsequent NP visits, including completion of the Clinical Assessment Form and the pelvic exam performed by the NP are all part of the standard treatment plan that all patients receive at the Female Sexual Medicine Program. PhD follow-up visits can be based upon the treatment plan of the patient and is not always necessary within the specified study time points.Behavioral: questionnaires
Assessment Form as part of routine clinical care. Participants will be asked to complete questionnaires at the baseline initial evaluation, 4-6 weeks, 12-14 weeks, and 22-24 weeks. The study information collected will be found in the standardized Clinical Assessment Form that patients complete as part of routine clinical care, along with an additional survey pertinent to the aims of the study. At 24 weeks, participants will complete an additional questionnaire that will ask questions regarding their experience with HyaloGYN® and their acceptability of and satisfaction with the product. Study participants must see the NP for the targeted exams at the study follow-up time points (4-6 weeks, 12-14 weeks, 22-24 weeks). PhD follow-up visits can be based upon the treatment plan of the patient. The study questionnaires (Appendix II-Follow-Up and Appendix IV) and moisturizer diaries (Appendix III) will be completed and collected during the NP follow-up appointments.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738152
|Contact: Jeanne Carter, Ph.D.||646-888-5076|
|Contact: Maura Dickler, MD||646-888-5456|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Jeanne Carter, PhD 646-888-5076|
|Contact: Maura Dickler, MD 646-888-5456|
|Principal Investigator: Jeanne Carter, PhD|
|Principal Investigator:||Jeanne Carter, PhD||Memorial Sloan Kettering Cancer Center.|