menopause. Postmenopausal atrophic vaginitis
Conditions
Interventions
Intervention 1: Intervention group: Fifty participants received Iranian vaginal probiotic capsules, each package containing 12 capsules with an applicator. Each participant was provided with two packa
Sponsors
This study was self-funded.
Eligibility
Sex/Gender
Female
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: Postmenopausal women experiencing symptoms of vaginal dryness.
Exclusion criteria
Exclusion criteria: Unwillingness or inability to participate in the study or complete study procedures Contraindications to estrogen cream use, including: History of estrogen-sensitive cancers (e.g., breast cancer), Active vaginal infections or significant cervical pathologies, History of thromboembolic events or severe cardiovascular disease. Contraindications to vaginal probiotic use, such as: Known allergy or hypersensitivity to any component of the probiotic formulation, Immunocompromised status, which may increase the risk of infection or microbial imbalance, or active infection status observed in the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Severity of vaginal symptoms, including itching, burning, pain, irritability, dryness, discharge, and abnormal vaginal odor. Timepoint: Time Points:1) Baseline assessment prior to the start of treatment.2) Main assessment at the end of the third week of treatment.3) Follow-up assessments every 12 weeks from treatment initiation, until the end of the study period (12 weeks). A total of 3 times will be conducted. Method of measurement: Outcomes are measured using a standard questionnaire based on the Kupperman Index, which rates symptom severity on a 5-point scale: 1 (none), 2 (mild), 3 (moderate), 4 (severe), 5 (very severe).Questionnaires are completed by participants, and data are collected and analyzed in the field.;2) Severity of dyspareunia (pain or discomfort during sexual intercourse). These outcomes are considered dependent variables and are measured using a qualitative rating scale. Timepoint: Time Points:1) Baseline assessment prior to the start of treatment.2) Main assessment at the end of the third week of treatment.3) Follow-up assessments every 12 weeks from treatment initiation, until the end of the study period (12 weeks). A total of 3 times will be conducted. Method of measurement: Outcomes are measured using a standard questionnaire based on the Kupperman Index, which rates symptom severity on a 5-point scale: 1 (none), 2 (mild), 3 (moderate), 4 (severe), 5 (very severe).Questionnaires are completed by participants, and data are collected and analyzed in the field. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Maryam Deldar Pasikhani
Tehran University of Medical Sciences
Outcome results
None listed