Zinc Containing Vaginal Topical " Suppository "

NCT05453227 | Completed Phase 1 DMC

• 1 other identifier: Bahaa Mohamed
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 \[UTI\])

Conditions

Genitourinary Syndrome of Menopause

Outcome Measures

Primary Outcomes (1)

• The using of novel zinc-containing vaginal suppositories

  Assessment of postmenopausal symptoms as dryness, burning, and irritation by Vaginal Health Index (VHI) score: elasticity, fluid secretion, pH and epithelial mucosa (integrity) and moisture components. Each component is scored on a scale of 1 (worst) to 5 (best). Lower scores indicate more severe atrophy. VHI was calculated at baseline and 2 weeks after the treatment.

  From baseline to 2 weeks after using the zinc sulphate

Study Arms (2)

Zinc Group

ACTIVE COMPARATOR

25 cases will be undergo treatment with active ingredient

Drug: Zinc

Plcebo Group

PLACEBO COMPARATOR

25 cases will be undergo treatment with placebo

Drug: Zinc

Interventions

Zinc DRUG

To test the effect of a novel zinc-containing vaginal topical on GSM/VVA symptoms.

Plcebo Group; Zinc Group

Eligibility Criteria

• Age: 55 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

Al-Azhar University Hospitals and Ashmoun central hospital

Cairo, Elmenofia, Egypt

Location

MeSH Terms

Interventions

Zinc

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Assem Anwar, Professor

  Department of Obstetrics & Gynecology Faculty of Medicine for boys, Al-Azhar University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 12, 2022
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 30, 2022
• Last Updated: October 17, 2023

Record last verified: 2023-10

Locations

EG (1)