Zinc Containing Vaginal Topical " Suppository "

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: Female

Summary

The genitourinary syndrome of menopause (GSM) is a new term that describes various menopausal symptoms and signs associated with physical changes of the vulva, vagina, and lower urinary tract.

The GSM includes not only genital symptoms (dryness, burning, and irritation) and sexual symptoms (lack of lubrication, discomfort or pain, and impaired function), but also urinary symptoms (urgency, dysuria, and recurrent urinary tract infections [UTI])

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Egymedicalpedia

Criteria

Inclusion Criteria:

• presence of symptoms of vulvovaginal atrophy/GSM in postmenopausal women. including vaginal dryness, burning, itching, vagina pain and dyspareunia. To be defined as a postmenopausal woman.

individuals had to have at least 12 consecutive months of amenorrhea without any other obvious reason/or consistently elevated follicle-stimulating hormone blood levels of 30 mIU/mL or higher.

Exclusion Criteria:

• premenopausal state,

• local or systemic hormone therapy within the past six months

• vaginal infection at presentation

• cytological atypia

• prior radiation treatment

• history of breast, ovarian or other gynecological cancer

• pelvic organ prolapse > stage 2

• recent use (3 months) of any vaginal product or douching.