Clinical Trials Logo

Clinical Trial Summary

This study determined the efficacy of non-hormonal therapy with citalopram compared to fluoxetine, for the treatment of menopausal symptoms in Mexican women with vasomotor syndrome (VMS) and urogenital syndrome.


Clinical Trial Description

Women's reproductive life goes through a senescence process called transition to menopause, which generates an imbalance in estrogenic hormonal regulation that is more evident between the fifth and sixth decades of life. This condition allows the passage from an active reproductive stage to an inactive one, which triggers an adaptative physiological response to the reduction of estrogens. However, the progressive depletion of estrogen levels causes clinical signs and symptoms in the central nervous system, metabolism, musculoskeletal apparatus, urogenital system, and skin. These symptoms lead to disability, work absenteeism, and health costs, affecting the quality of life of women in this stage. Vasomotor symptoms are the main clinical manifestation for which women seek treatment. Vasomotor syndrome (VMS) occurs in 75 to 80% of all women. The first-line management of menopausal symptoms is hormone replacement therapy (HRT). However, some patients present adverse effects or contraindications for using it. The aim of this study was to determine the efficacy of the citalopram for treating menopausal symptoms in Mexican women with vasomotor syndrome (VMS) and urogenital syndrome. This study was a prospective randomized clinical trial, where 91 post-menopausal participants with severe baseline scores on the Menopause Rating Scale (MRS) were randomly selected and treated with citalopram (n=49) or fluoxetine (n=42). Changes from baseline MRS score at three and six months of treatment were evaluated. Participants were randomly assigned to groups before each consult. Randomization was done using RAND and RANK functions from Excel-Word to generate unique random numbers for every participant´s ID. Fluoxetine is the Gold Standard treatment in Mexico, whereby it was used as the control medication. Loading doses of citalopram 20 mg orally or fluoxetine 20 mg orally were administrated. Statical analysis was performed using PAST 3.0 and GraphPad Prism 8.4.3. software. Some statical parameters, such as arithmetic median (µ), standard deviation (S.D.), and Hazard ratio, were calculated using Excel-Word. Graphics were constructed with GraphPad Prism 8.4.3. Tables and Forest plots were done in Excel-Word. Odds ratio (OR), Relative Risk (RR), and chi-squared were calculated with PAST 3.0 software. The assigned α value for this study was <0.05. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05346445
Study type Interventional
Source Hospital Regional 1o de Octubre
Contact
Status Completed
Phase N/A
Start date January 20, 2021
Completion date December 20, 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04587154 - Womens Study to Alleviate Vasomotor Symptoms N/A
Terminated NCT03642119 - Validation of an Objective Instrument to Measure Hot Flashes During Menopause
Completed NCT05061563 - A Study to Learn How a Proton Pump Inhibitor Affects the Way Elinzanetant (BAY 3427080) Moves Into, Through and Out of the Body, and How Much of it Gets Absorbed by the Body When Taken as a Single and Small Radioactive Dose in Healthy Adults Phase 1
Completed NCT05419908 - Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes Phase 2
Completed NCT01281332 - Mechanical Device for the Relief of Hot Flashes Phase 2
Completed NCT01439945 - Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer Phase 2
Completed NCT00755417 - Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women Phase 3
Completed NCT01293695 - Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial N/A
Completed NCT00599456 - Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women. N/A
Completed NCT00256685 - Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause Phase 3
Completed NCT00391417 - Efficacy and Safety of a Topical Estradiol Gel for Treatment of Postmenopausal Symptoms Phase 3
Terminated NCT00244894 - Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer N/A
Completed NCT00010712 - Effects of Black Cohosh on Menopausal Hot Flashes Phase 2
Active, not recruiting NCT03580499 - Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy N/A
Recruiting NCT06030388 - Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women N/A
Recruiting NCT04418115 - Fatigue as a Late Effect in Breast Cancer Survivors - is Acupuncture a Treatment Option? N/A
Recruiting NCT04861701 - Effect and Predictors for Hot Flush in Women Undergoing Static Stretching Exercise N/A
Active, not recruiting NCT05086705 - EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer N/A
Completed NCT05099159 - A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2) Phase 3
Completed NCT01140646 - Evaluation of SAMe for Hot Flashes Phase 2