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Comparison of the Effect of Sertraline Tablets with Vaginal Probiotics on the Improvement of Postmenopausal Symptoms

Comparison of the Effect of Sertraline Tablets with Vaginal Probiotics on the Improvement of Postmenopausal Symptoms

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241004063255N1
Enrollment
86
Registered
2025-02-27
Start date
2025-01-03
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal women. Unspecified menopausal and perimenopausal disorder

Interventions

Intervention 1: Intervention group: This group was treated with vaginal probiotics containing live microorganisms.These probiotics, such as lactobacilli, when administered in adequate amounts, help im

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 60 Years

Inclusion criteria

Inclusion criteria: Women aged 45-60 who are experiencing one or more symptoms of menopause These individuals are unable to receive hormone replacement therapy due to contraindications, including abnormal vaginal bleeding, malignancy, deep vein thrombosis, pulmonary embolism, arterial thromboembolism, various thrombophilias, benign and malignant breast masses, liver disease, cardiovascular disease, suspected pregnancy, and allergies These individuals must provide informed consent to participate in the study

Exclusion criteria

Exclusion criteria: Women with premature menopause Women with a history of hysterectom Women with blindness Women with Deafness Women with severe illness (defined as death or patients receiving critical care) Women with a history of sensitivity to the drug sertraline Women consuming estrogenic drugs and estrogen-containing compounds such as fennel Women with mental illnesses such as schizophrenia Women who have been hospitalized in the past three months

Design outcomes

Primary

MeasureTime frame
Improvement in menopausal symptoms as measured by the total score of the Menopause Rating Scale (MRS). This scale is designed to assess the severity of menopausal symptoms across three main domains:    Vasomotor symptoms (e.g., hot flashes, night sweats), Psychological symptoms (e.g., depression, anxiety, sleep disorders), Somatic symptoms (e.g., joint pain, vaginal dryness, and other physical issues).The MRS score was assessed at baseline (pre-intervention) and after 12 weeks of treatment (post-intervention) for each participant. The change in the total MRS score before and after the intervention was used as an indicator to evaluate the effectiveness of the interventions (vaginal probiotics vs. sertraline) in alleviating menopausal symptoms.Calculation Method: A reduction in the total MRS score after the intervention reflects an improvement in menopausal symptoms. The sample size of the study was determined based on this primary outcome variable. Timepoint: 12 weeks after the initiation of vaginal probiotics and sertraline. Method of measurement: Menopause Rating Scale questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Niksolat

Iran University of Medical Sciences

dmniksolat@gmail.com+98 21 5750 9000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026