Via, a Hyaluronic Acid (HLA) Based Vaginal Moisturizer Study

NYU Langone Health

Status

Not yet enrolling

Conditions

Genitourinary Syndrome of Menopause (GSM)

Treatments

Device: Via Solv Wellness (Hyaluronic Acid Therapy)

Drug: Vaginal estrogen tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT07038070

25-00415

Details and patient eligibility

About

This study aims to evaluate whether the administration of vaginal estrogen along with Via, a hyaluronic acid-based vaginal moisturizer, offers superior relief from symptoms of genitourinary syndrome of menopause (GSM) in the urogynecologic patient population, compared to administration of vaginal estrogen alone.

Enrollment

196 estimated patients

Sex

Female

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Postmenopausal (last menstrual period at least 12 months ago).
Aged 45 years or older and have symptoms of Genitourinary Syndrome of Menopause (GSM).
Have never tried vaginal estrogen therapy, or have tried vaginal estrogen therapy, but have not used vaginal estrogen and/or hyaluronic acid products for management of GSM symptoms within the last 3 months.
Capable of signing informed consent.
Capable and willing to follow all study-relation visits.

Exclusion criteria

Subjects currently diagnosed with or undergoing treatment for hormone-sensitive disease (e.g. breast cancer)
Subjects currently using systemic hormone replacement therapy
Subjects currently using estrogen hormonal therapies or hormone modulators (aromatase inhibitors or selective estrogen receptor modulators)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

196 participants in 2 patient groups

Vaginal Estrogen + Hyaluronic acid (HLA)

Experimental group

Description:

Participants will administer vaginal estrogen tablets nightly for 2 weeks, then twice weekly for 14 weeks. Participants will concomitantly apply Via (Hyaluronic acid) nightly for 16 weeks.

Treatment:

Drug: Vaginal estrogen tablet

Device: Via Solv Wellness (Hyaluronic Acid Therapy)

Vaginal Estrogen Alone

Active Comparator group

Description:

Participants will administer vaginal estrogen tablets nightly for 2 weeks, then twice weekly for 14 weeks.

Treatment:

Drug: Vaginal estrogen tablet