A Study of the Efficacy and Safety of Paroxetine versus Gabapentin in Menopausal Vasomotor Symptoms
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Hot Flash Score for frequency and severity of Vasomotor Symptoms
Study Overview
Brief Summary
Menopausal vasomotor symptoms (VMS)—including hot flashes and night sweats—are among the most common and distressing complaints experienced by perimenopausal and postmenopausal women, often impairing sleep, mood and overall quality of life. These symptoms arise from estrogen decline, hypothalamic thermoregulatory instability and neurochemical changes involving serotonin, norepinephrine and GABA pathways. Although menopausal hormone therapy remains the most effective treatment, its long-term risks necessitate safer non-hormonal alternatives. Paroxetine, an SSRI, and Gabapentin, a GABA analogue, have both shown potential in reducing VMS frequency and improving sleep, though their comparative effectiveness and safety profiles remain inadequately explored.
This prospective, randomized, open-label clinical study aims to evaluate and compare the efficacy and safety of Paroxetine versus Gabapentin in women experiencing menopausal vasomotor symptoms. A total of 60 eligible participants will be enrolled after informed consent and randomly assigned into two groups: Group A will receive Paroxetine 12.5 mg once daily, while Group B will receive Gabapentin 300 mg three times daily for 12 weeks. Both medications are selected based on existing evidence supporting their roles in thermoregulatory modulation and symptom relief.
At baseline, participants will undergo assessment using the Hot Flash Score, Pittsburgh Sleep Quality Index (PSQI), Zung Self-Rating Depression Scale (SDS) and the Greene Climacteric Scale (GCS). Follow-up evaluations will take place at baseline, 4, 8 and 12 weeks to monitor changes in vasomotor symptoms, sleep quality, mood and overall menopausal well-being. Adverse drug reactions will be documented throughout the study to evaluate the tolerability and safety of both treatments.
The study seeks to determine which therapy provides greater reduction in VMS burden, better sleep and psychological outcomes and improved quality of life, while maintaining an acceptable safety profile. Outcomes from this research may guide clinicians in selecting effective, non-hormonal therapeutic options for managing menopausal vasomotor symptoms.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 40.00 Year(s) to 60.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Females of age group (40-60 years).
- •Perimenopausal and Menopausal women with Vasomotor Symptoms.
- •Patients willing to give a written informed consent.
Exclusion Criteria
- •Patients on any anti-depressant or antipsychotic drugs.
- •Patient on any serotonergic drugs.
- •Patient on Tamoxifen therapy.
- •Undiagnosed Vaginal bleeding.
- •History of suicide attempts or suicidal ideation.
- •History of epilepsy or seizures.
- •Known allergy or hypersensitivity to Paroxetine or Gabapentin
- •Uncontrolled hypertension.
- •History of cardiac disease.
Outcomes
Primary Outcomes
Hot Flash Score for frequency and severity of Vasomotor Symptoms
Time Frame: 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 Outcomes
- 1. Assessment of Sleep Quality by Pittsburgh Sleep Quality Index.(2. Assessment of Depression by The Zung Self-Rating Depression Scale (SDS))
Investigators
Dr Jyoti Kaushal
Pt. B.D. Sharma, PGIMS, Rohtak