Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause
Launched by UNIVERSIDAD NACIONAL AUTONOMA DE HONDURAS · Jan 6, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effectiveness of a medication called paroxetine in helping women manage hot flashes and night sweats that occur after surgical menopause. Surgical menopause happens when a woman’s ovaries are removed, leading to various symptoms, including discomfort from vasomotor symptoms like hot flashes. The trial aims to find an alternative treatment to hormone therapy, which can increase certain health risks for some women, particularly those with conditions like diabetes or high blood pressure.
To be eligible for this trial, women aged 29 to 74 who are experiencing hot flashes, night sweats, anxiety, or palpitations due to surgical menopause can participate. Participants should not be taking other psychiatric medications or hormone therapy and should have no serious heart, liver, or kidney issues. If chosen to participate, women will take paroxetine for six months and will receive support and information throughout the process. This trial is an opportunity to explore new treatment options in a safe and monitored environment.
Gender
FEMALE
Eligibility 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.
About Universidad Nacional Autonoma De Honduras
The Universidad Nacional Autónoma de Honduras (UNAH) is a leading academic institution committed to advancing research and innovation in the field of health sciences. As a clinical trial sponsor, UNAH leverages its extensive expertise and resources to facilitate high-quality research aimed at improving patient outcomes and addressing public health challenges in Honduras and beyond. With a focus on ethical practices and collaboration, UNAH engages in multidisciplinary studies that contribute to the global body of knowledge while fostering the development of local scientific talent.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tegucigalpa, Francisco Morazán, Honduras
Tegucigalpa, , Honduras
Patients applied
Trial Officials
Ricardo A. Gutierrez Ramirez
Study Director
Universidad Nacional Autonoma de Honduras
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported