Non-Hormonal Vaginal Moisturizer in Hormone-Receptor Positive Postmenopausal Cancer Survivors Experiencing Estrogen Deprivation Symptoms on Vulvovaginal Health

• Register: ClinicalTrials.gov
• Last refreshed on: 2 August 2021
• Main ID: NCT01738152
• Date of registration: 28/11/2012
• Prospective Registration: No
• Primary sponsor: Memorial Sloan Kettering Cancer Center
• Public title: Non-Hormonal Vaginal Moisturizer in Hormone-Receptor Positive Postmenopausal Cancer Survivors Experiencing Estrogen Deprivation Symptoms on Vulvovaginal Health
• Scientific 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
• Date of first enrolment: November 2012
• Target sample size: 106
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01738152
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Jeanne Carter, PhD
• Affiliation: Memorial Sloan Kettering Cancer Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- History of breast cancer or endometrial cancer confirmed at MSKCC or outside pathology
report

- Breast cancer patients must be at least 3 months post-active treatment (including
chemotherapy, radiation therapy, endocrine therapy, and/or maintenance therapy), but
not greater than 5 years post-active treatment (exception: AIs are required, and
monoclonal antibodies are allowed)

- Breast cancer patients must be currently on adjuvant aromatase inhibitors

- Endometrial cancer patients must be at least 3 months post-active chemotherapy and/or
maintenance therapy treatment but not greater than 5 years post-active chemotherapy
and/or maintenance therapy treatment. They must be at least 4 weeks post-radiation
therapy (EBRT or IVRT) but not greater than 5 years post-radiation therapy.

- Endometrial cancer patients must have underwent surgical treatment (total abdominal
hysterectomy ([TAH]/BSO)) and radiation therapy (external beam radiation therapy
[EBRT] or IVRT)

- Currently have no clinical evidence of disease

- Menopausal at study entry as described by:

- Surgical menopause (TAH/BSO), or

- Age = 50 years and cessation of menstruation for at least 1 year, or

- Age <50 years and cessation of menstruation for at least 1 year with estradiol level
in post-menopausal range, or

- Rendered post-menopausal with the use of LHRH agonist

- Patients who are new visits to Female Sexual Medicine Program or patients are not
consistently using any vulvovaginal health promotion strategies (e.g., pelvic floor
exercises, dilator therapy, moisturizers) recommended by the Female Sexual Medicine
Program Reporting being bothered by vulvovaginal symptoms of estrogen deprivation
(i.e., vulvovaginal dryness or discomfort [pain with intercourse or examination])

- Without history of other cancers (excluding non-melanoma skin cancer)

- Women at least 18 years of age

- Able to read and speak English

- Able to participate in the informed consent process

Exclusion Criteria:

- Inability to provide informed consent

- Vaginal bleeding of unknown etiology within 12 months of study entry

- Currently taking hormone replacement therapy [local or systemic] (Patients must
discontinue for 2 weeks in order to be eligible prior to study enrollment)



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Endometrial Cancer

Breast Cancer

Intervention(s)

Behavioral: questionnaires

Other: HLA vaginal gel (HyaloGYN®),

Primary Outcome(s)

investigate feasibility of conducting a 12-week HLA treatment regimen [Time Frame: 12-week]

Secondary Outcome(s)

Vulvar Assessment Composite Score [VuAS] [Time Frame: 12 weeks post-HLA treatment initiation]

Vaginal Assessment Composite Score [VAS] [Time Frame: 12 weeks post-HLA treatment initiation]

Secondary ID(s)

12-232

Source(s) of Monetary Support

Please refer to primary and secondary sponsors