Postmenopausal Pessary Users: Estrogen Versus Trimosan
Phase 4
Terminated
- Conditions
- VaginosisVaginosis, BacterialVaginal Discharge
- Interventions
- Drug: Estrogen vaginal creamDrug: Trimo-San vaginal gel
- Registration Number
- NCT03943823
- Brief Summary
The purpose of the study is to compare vaginally applied estrogen with the vaginal gel trimosan for their effects on vaginal pH and vaginal symptoms in postmenopausal pessary users.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 4
Inclusion Criteria
- Postmenopausal female pessary user (ring with support pessaries only). Postmenopausal will be defined as: amenorrhea for a year or 3 months after surgical bilateral salpingo-oophorectomy
- Is a new pessary user, or has not had a pessary for a year
Exclusion Criteria
- Pregnancy
- Persistent Bacterial Vaginosis infection in the first two clinic encounters
- Currently on hormone replacement therapy
- Previously on hormone replacement therapy in the past 6 months
- Currently on antibiotics
- Patients with existing vaginal erosions/ulcerations
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Estrogen vaginal cream Estrogen vaginal cream - Trimo-San vaginal gel Trimo-San vaginal gel -
- Primary Outcome Measures
Name Time Method Vaginal pH as Measured by pH Strips 3 months pH is measured on a scale of 0 to 14, with lower values indicating greater acidity and higher values indicating greater alkalinity.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire 3 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms explain estrogen's effect on vaginal pH in postmenopausal women using pessaries?
How does trimosan vaginal gel compare to standard-of-care treatments for bacterial vaginosis in postmenopausal pessary users?
Are there specific biomarkers that predict response to estrogen therapy versus trimosan in postmenopausal vaginal health?
What adverse events are associated with long-term use of estrogen vaginal cream in postmenopausal populations?
What are the potential synergies between estrogen-based therapies and trimosan in managing vaginal symptoms and pH balance?
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
The University of Texas Health Science Center at Houston🇺🇸Houston, Texas, United States