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Comparing Combination therapy with Probiotics and Estrogen vaginal cream versus Estrogen vaginal cream for treatment of urinary and genital problems in Postmenopausal women

Combination therapy with Probiotics and Estrogen vaginal cream versus Estrogen vaginal cream for treatment of genitourinary syndrome in Postmenopausal women ? A Randomized open label clinical trial - nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093368
Enrollment
120
Registered
2025-08-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: N958- Other specified menopausal and perimenopausal disorders

Interventions

Intervention1: Oral probiotics and vaginal estrogen cream : Multiflora-V per oral 1 tablet daily at night after food for 3months and estrogen cream(0.1% estriol cream) per vaginum to be applied in the

Sponsors

Dr.Bommareddy Pooja
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Postmenopausal women with genitourinary syndrome Diagnosis of GSM in our study will be based on the presence of at least 1 symptoms with pH more than or equal to 4.5 and the symptoms not attributed to any other pathology Symptoms Genital -Dryness, Burning, Irritation Sexual -Lack of lubrication, discomfort or pain Urinary- Urgency, Dysuria, Recurrent UTI

Exclusion criteria

Exclusion criteria: Previous local or systemic menopausal hormone therapy Hormone -dependent tumors Vaginal bleeding of unknown cause Taken antibiotics 2 weeks prior to start treatment Any other lesions in cervix, vagina and vulva Acute infections of the genital tract, use of any vaginal therapy, severe systemic diseases, all contraindications for administration of estrogen, and participation in another study. Patients already taking probiotics.

Design outcomes

Primary

MeasureTime frame
CHECK FOR THE NUGENT SCORE VAGINAL PH CLINICAL IMPROVEMENT VAGINAL HEALTH INDEXTimepoint: CHECK FOR THE NUGENT SCORE VAGINAL PH CLINICAL IMPROVEMENT VAGINAL HEALTH INDEX at 8weeks and 12weeks

Secondary

MeasureTime frame
nilTimepoint: nil

Countries

India

Contacts

Public ContactDr Bommareddy Pooja

SRM Medical College Hospital and research centre

j.karthigaprabhu@gmail.com9894269895

Outcome results

None listed

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