Using paroxetine to manage hot flashes in women with surgical menopause
Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause. Randomized Double-blind Clinical Trial
PHASE2 · Universidad Nacional Autonoma de Honduras · NCT06763484
This study is testing if the medication paroxetine can help women who have had surgery for menopause manage hot flashes and night sweats better than a placebo.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Universidad Nacional Autonoma de Honduras (other) |
| Locations | 1 site (Tegucigalpa, Francisco Morazán) |
| Trial ID | NCT06763484 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of paroxetine, a selective serotonin reuptake inhibitor, in managing vasomotor symptoms such as hot flashes and night sweats in women who have undergone surgical menopause. The research aims to provide an alternative to hormone therapy, which is often contraindicated for patients with certain health risks. Participants will receive either paroxetine or a placebo for a duration of six months, with the goal of assessing symptom reduction and overall quality of life improvements. The study focuses on women who experience these symptoms due to surgical procedures like total abdominal hysterectomy and bilateral salpingo-oophorectomy.
Who should consider this trial
Good fit: Ideal candidates are women experiencing surgical menopause with hot flashes and night sweats who are not on hormone therapy.
Not a fit: Patients currently taking psychotropic medications or those with a history of psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a non-hormonal treatment option for women suffering from vasomotor symptoms after surgical menopause.
How similar studies have performed: Previous studies have explored the use of SSRIs for managing menopausal symptoms, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with surgical menopause attending IHSS outpatient clinic. * Patients with surgical menopause with presence of hot flashes and night sweats. * Surgical menopausal patients with episodes of anxiety and palpitations. * Patients with surgical menopause who receive treatment for 6 months with Paroxetine. * Patients who after reading and explanation of the Informed Consent agree to participate voluntarily. Exclusion Criteria: * Patients medicated with psychotropic drugs, including all sedatives and hypnotics. * Patients under treatment with Menopausal Hormone Therapy. * Patients with impaired hepatic or renal function. * Patients with unstable heart disease. * Patients with a history of self-destructive behaviors. * Patients with a history of clinical diagnosis or treatment for depression or any other psychiatric disorder (including substance abuse or alcohol disorders) and any other ongoing medical condition.
Where this trial is running
Tegucigalpa, Francisco Morazán
- Instituto Hondureño de Seguridad Social — Tegucigalpa, Francisco Morazán, Honduras (RECRUITING)
Study contacts
- Study coordinator: Ricardo A Gutierrez Ramirez
- Email: ricardo.gutierrez@unah.edu.hn
- Phone: 97546940
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Menopause Syndrome, Menopause Surgical, Hot Flashes, Paroxetine