Non-Hormonal Vaginal Moisturizer in Hormone-Receptor Positive Postmenopausal Cancer Survivors Experiencing Estrogen Deprivation Symptoms on Vulvovaginal Health
|ClinicalTrials.gov Identifier: NCT01738152|
Recruitment Status : Active, not recruiting
First Posted : November 30, 2012
Last Update Posted : February 23, 2018
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer Endometrial Cancer||Other: HLA vaginal gel (HyaloGYN®), Behavioral: questionnaires|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 on Vulvovaginal Health|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
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 and vulvar 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 for hydration and lubrication of the vaginal epithelium for women suffering dryness,as well as to the vulva for women suffering from vulvar symptoms. All 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. The women with vulvar symptoms at the baseline assessment will additionally be instructed to apply the HLA gel onto the vulva (manually) daily for the first 2 weeks, and then 3 times per week for 10 weeks. The participants will be assessed at 12 weeks. Participants receiving benefit from HyaloGYN®, as operationalized by improvement in both vaginal pH and VAS score will continue using the product 3 times per week for another 12 weeks and will receive a final vulvovaginal assessment at 24 weeks post-HLA treatment initiation.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 FSM NP or GYN clinician 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 and moisturizer diaries will be completed and collected during follow-up appointments with the GYN clinician or FSM NP.
- investigate feasibility of conducting a 12-week HLA treatment regimen [ Time Frame: 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).
- Vaginal Assessment Composite Score [VAS] [ Time Frame: 12 weeks post-HLA treatment initiation ]as measured by the Vaginal Assessment Composite Score [VAS], vaginal pH and epithelial atrophy)
- Vulvar Assessment Composite Score [VuAS] [ Time Frame: 12 weeks post-HLA treatment initiation ](as measured by the Vulvar Assessment Composite Score [VuAS], vulvar atrophy, and vulvar/vestibular irritation)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738152
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Jeanne Carter, PhD||Memorial Sloan Kettering Cancer Center|