CompletedNot Applicable

Natural Topical Treatment for Vulvar and Vaginal Atrophy

Italy50 participantsStarted 2022-01-05

Plain-language summary

Genitourinary syndrome of menopause (GSM) is a chronic and progressive syndrome characterized by a collection of genital and urinary signs and symptoms secondary to the state of hypoestrogenism related to menopause.

Who can participate

Age range45 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 45-65 years * Menopause and symptomatic vulvovaginal atrophy (VVA) (vaginal dryness, dyspareunia, vaginal irritation, vaginal itching, dysuria) * No previous treatment for VVA * Informed written consent signed Exclusion Criteria: * Pregnancy * Previous or concurrent neoplasms * Uncompensated concomitant diseases (i.e., diabetes, cardiac diseases) * Previous or concurrent Hormone replacement therapy (HRT) or radiotherapy or chemotherapy.

What they're measuring

Change in vaginal health index score

Timeframe: 5.5 months

Change in Female Sexual Distress Scale (FSD)

Timeframe: 5.5 months

Trial details

NCT IDNCT05871255

SponsorDr. Amjad Khan

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-06-30

View on ClinicalTrials.gov More Genitourinary Syndrome of Menopause trials