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A Study to Compare the Safety and Effectiveness of Paroxetine and Gabapentin in Women with Menopausal Vasomotor Symptoms

A Study of the Efficacy and Safety of Paroxetine versus Gabapentin in Menopausal Vasomotor Symptoms - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099209
Enrollment
60
Registered
2025-12-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: N951- Menopausal and female climactericstates

Interventions

Intervention1: Paroxetine: Paroxetine 12.5 mg will be given once daily for a total duration of 3 months. The enrolled patients will be assessed at baseline, 4 weeks, 8 weeks and 12 weeks for Hot Flash

Sponsors

Pt. B.D. Sharma, PGIMS, Rohtak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Females of age group (40-60 years). 2. Perimenopausal and Menopausal women with Vasomotor Symptoms. 3. Patients willing to give a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients on any anti-depressant or antipsychotic drugs. 2. Patient on any serotonergic drugs. 3. Patient on Tamoxifen therapy. 4. Undiagnosed Vaginal bleeding. 5. History of suicide attempts or suicidal ideation. 6. History of epilepsy or seizures. 7. Known allergy or hypersensitivity to Paroxetine or Gabapentin 8. Uncontrolled hypertension. 9. Impaired liver or kidney function. 10. History of cardiac disease.

Design outcomes

Primary

MeasureTime frame
Hot Flash Score for frequency and severity of Vasomotor SymptomsTimepoint: Participants will be assessed initially during enrollment for baseline parameters and will be followed up at 4 weeks, 8 weeks and 12 weeks for assessment of Hot Flash Score for frequency and severity of Vasomotor Symptoms—

Secondary

MeasureTime frame
1. Assessment of Sleep Quality by Pittsburgh Sleep Quality Index. 2. Assessment of Depression by The Zung Self-Rating Depression Scale (SDS) 3. Quality of life parameters using the Greene Climacteric Scale Timepoint: Participants will be assessed initially during baseline parameters and will be followed up at 4 weeks,8 weeks and 12weeks for assessment of Sleep Quality by Pittsburgh Sleep Quality Index,Assessment of Depression by The Zung Self-Rating Depression Scale (SDS) and Quality of life parameters using the Greene Climacteric Scale—

Countries

India

Contacts

Public ContactDr Anshika

Pt. B.D. Sharma, PGIMS, Rohtak

anshikaarya0002@gmail.com7027388636

Outcome results

None listed

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