Zinc Containing Vaginal Topical " Suppository " in Improving Post Menopausal Genitourinary Syndrome: "Double Blind Controlled Study "
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Egymedicalpedia
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- The using of novel zinc-containing vaginal suppositories
Study Overview
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])
Detailed Description
The terms vulvovaginal atrophy and atrophic vaginitis were widely used until recently, but they have been considered to be inadequate for referring to the constellation of symptoms and signs associated with the genitourinary system after menopause.
The term vulvovaginal atrophy mentions the vulva and vagina only, and these words are not used comfortably in general social discussion and in the media. The term atrophic vaginitis implies a state of inflammation or infection, which is not a primary component of menopausal changes. In addition, a limitation of the terms vulvovaginal atrophy and atrophic vaginitis is that they do not take into account the symptoms of the lower urinary tract, which are among the most important symptoms related to menopause.
Vulvovaginal atrophy (VVA) is a prevalent condition affecting many postmenopausal women.1 Up to 40% of postmenopausal women develop symptoms of VVA.
It is most often diagnosed by its symptoms, including vaginal dryness, burning, itching, vagina pain and dyspareunia. More recently these symptoms have been described as a syndrome: the genitourinary syndrome of menopause (GSM).
This new term describes various menopausal symptoms and signs including not only genital symptoms but sexual (pain) and urinary symptoms (dysuria, urgency) as well.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Zinc Group
25 cases will be undergo treatment with active ingredient
Intervention: Zinc (Drug)
Plcebo Group
25 cases will be undergo treatment with placebo
Intervention: Zinc (Drug)
Outcomes
Primary Outcomes
The using of novel zinc-containing vaginal suppositories
Time Frame: From baseline to 2 weeks after using the zinc sulphate
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.
Secondary Outcomes
No secondary outcomes reported