Changes in Neighbouring Microbiota in Genitourinary Syndrome

What this trial studies

Genitourinary syndrome (GUS) is a disease seen in menopause, which significantly reduces the quality of life of patients. Microbiota studies in GUS are mostly related to vaginal microbiota. However, although urinary problems are also common in GUS, there are less studies on urobiome and no studies on periurethral microbiota. It is recently shown that especially in patients with dyspareunia vaginal microbiota mostly consists of Streptococcus species.

Conditions in scope

• Genitourinary Syndrome of Menopause

Interventions

• Vaginal Cream with Applicator (Drug) — Vaginal Cream that contains estriol (1mg estriol in 1 g cream)

Who can join

Women only · Ages 40 Years and up · Accepts healthy volunteers.

Inclusion criteria

• Patients who have been in menopause for at least 1 year
• Patients with symptoms of genitourinary syndrome (those with symptoms such as vaginal dryness, frequent urination, burning sensation during urination, pain during intercourse)

Exclusion criteria

• Patients with severe overactive bladder symptoms
• Patients receiving systemic hormone replacement therapy or local estrogen therapy or have received it within the last 3 months
• Patients using vaginal probiotic products
• Patients with advanced pelvic organ prolapse
• Patients with a history of estrogen-dependent breast or endometrial cancer
• Patients allergic to local estrogen
• Patients with urinary tract infection at first presentation or patients who have used antibiotics within the last 2 weeks

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE4
• Start date: 2023-11-10
• Primary completion: 2024-07-10
• Last update posted: 2024-10-09
• First posted: 2024-10-09

Sponsor & contact

Lead sponsor: Koc University Hospital (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Vaginal, periurethral and urinary bladder microbiota (3 months)
  Microbiota contents of 3 areas (vagina, periurethra and bladder) will be obtain and compared to each other

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.