Clinical trial

Zinc Containing Vaginal Topical " Suppository " in Improving Post Menopausal Genitourinary Syndrome: "Double Blind Controlled Study "

Name
Bahaa Mohamed
Description
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 \[UTI\])
Trial arms
Trial start
2021-12-01
Estimated PCD
2022-12-01
Trial end
2022-12-30
Status
Completed
Phase
Early phase I
Treatment
Zinc
To test the effect of a novel zinc-containing vaginal topical on GSM/VVA symptoms.
Arms:
Plcebo Group, Zinc Group
Size
50
Primary endpoint
The using of novel zinc-containing vaginal suppositories
From baseline to 2 weeks after using the zinc sulphate
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2023-10-17

1 organization

1 product

1 indication

Organization
Egymedicalpedia
Product
Zinc