Comparison of Fluoxetine Versus Citalopram Therapy to Control Postmenopausal Vasomotor Syndrome

Sponsor

Hospital Regional 1o de Octubre (Other)

Overall Status

Completed

CT.gov ID

NCT05346445

Collaborator

Universidad Nacional Autonoma de Mexico (Other), National Polytechnic Institute, Mexico (Other)

Enrollment

Location

Arms

Actual Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Postmenopause Hot Flashes	Drug: Fluoxetine 20 MG Drug: Citalopram 20mg	N/A

Detailed 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

Study Type:

Interventional

Actual Enrollment :

91 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This study was a prospective randomized clinical trial made in Mexican women diagnosed with postmenopause from the climacteric clinic of the regional hospital "1ro de Octubre-Instituto de Seguridad y Servicios Sociales para los Trabajadores del Estado (ISSSTE)". Eligible participants were randomly selected in each consult to receive citalopram 20 mg/d or fluoxetine 20 mg/d for six months. The evaluation of the MRS score was done at the first consult and three and six months after medication. The institutional ethical committee of the hospital approved the study on May 20th, 2021, with registration number CONBIOETICA-09-CEI-012-20170421 and the internal registration number 122.2021. All participants provided written informed consent.This study was a prospective randomized clinical trial made in Mexican women diagnosed with postmenopause from the climacteric clinic of the regional hospital "1ro de Octubre-Instituto de Seguridad y Servicios Sociales para los Trabajadores del Estado (ISSSTE)". Eligible participants were randomly selected in each consult to receive citalopram 20 mg/d or fluoxetine 20 mg/d for six months. The evaluation of the MRS score was done at the first consult and three and six months after medication. The institutional ethical committee of the hospital approved the study on May 20th, 2021, with registration number CONBIOETICA-09-CEI-012-20170421 and the internal registration number 122.2021. All participants provided written informed consent.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Citalopram Improves Vasomotor and Urogenital Syndromes in Mexican Patients With Post-menopause

Actual Study Start Date :

Jan 20, 2021

Actual Primary Completion Date :

Nov 20, 2021

Actual Study Completion Date :

Dec 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Fluoxetine group Participants received fluoxetine, 20 mg tablets, once a day for six months.	Drug: Fluoxetine 20 MG Participants received non-hormonal treatment with fluoxetine. Other Names: Generic PISA®
Experimental: Citalopram group Participants received citalopram, 20 mg tablets, once a day for six months.	Drug: Citalopram 20mg Participants received non-hormonal treatment with citalopram. Other Names: PREPRAM®

Arm

Intervention/Treatment

Active Comparator: Fluoxetine group

Participants received fluoxetine, 20 mg tablets, once a day for six months.

Drug: Fluoxetine 20 MG

Participants received non-hormonal treatment with fluoxetine.

Other Names:

Generic PISA®

Experimental: Citalopram group

Participants received citalopram, 20 mg tablets, once a day for six months.

Drug: Citalopram 20mg

Participants received non-hormonal treatment with citalopram.

Other Names:

PREPRAM®

Outcome Measures

Primary Outcome Measures

Change from baseline Menopause Rating Scale (MRS) total score at 3 months [3 months]
Menopause Rating Scale measures the severity of ageing symptoms and their impact on Health-Related Quality of Life. It considers the score of the somatic, urogenital, and psychological domains. A score of 0-4 was considered minimal severity, 5-8 mild, 9-16 moderate, and greater than 17 severe.
Change from baseline Menopause Rating Scale (MRS) total score at 6 months [6 months]
Menopause Rating Scale measures the severity of ageing symptoms and their impact on Health-Related Quality of Life. It considers the score of the somatic, urogenital, and psychological domains. A score of 0-4 was considered minimal severity, 5-8 mild, 9-16 moderate, and greater than 17 severe.
Change from baseline Menopause Rating Scale (MRS) somatic domain score at 3 months [3 months]
It considers the score obtained from the somatic dimension, which includes hot flashes, heart problems, sleep problems, and muscle and joint pain. A score of 0-2 was considered minimal severity, 3-4 mild, 5-8 moderate, and greater than 9 severe.
Change from baseline Menopause Rating Scale (MRS) somatic domain score at 6 months [6 months]
It considers the score obtained from the somatic dimension, which includes hot flashes, heart problems, sleep problems, and muscle and joint pain. A score of 0-2 was considered minimal severity, 3-4 mild, 5-8 moderate, and greater than 9 severe.
Change from baseline Menopause Rating Scale (MRS) urogenital domain score at 3 months [3 months]
It considers the score obtained from the urogenital dimension, which includes sexual problems, bladder problems and vaginal dryness. A score of 0 was considered minimal severity, 1 mild, 2-3 moderate, and greater than 4 severe.
Change from baseline Menopause Rating Scale (MRS) urogenital domain score at 6 months [6 months]
It considers the score obtained from the urogenital dimension, which includes sexual problems, bladder problems and vaginal dryness. A score of 0 was considered minimal severity, 1 mild, 2-3 moderate, and greater than 4 severe.
Change from baseline Menopause Rating Scale (MRS) psychological domain score at 3 months [3 months]
It considers the score obtained from the psychological dimension, which includes depression, irritability, anxiety and tiredness. A score of 0-1 was considered minimal severity, 2-3 mild, 4-6 moderate, and greater than 7 severe.
Change from baseline Menopause Rating Scale (MRS) psychological domain score at 6 months [6 months]
It considers the score obtained from the psychological dimension, which includes depression, irritability, anxiety and tiredness. A score of 0-1 was considered minimal severity, 2-3 mild, 4-6 moderate, and greater than 7 severe.
Change from baseline score in Item 1 of the Menopause Rating Scale (MRS) at 3 months [3 months]
Item 1 considers the score obtained from hot flashes on the MRS scale. 0 points were assigned if the participants reported no symptoms, 1 point if they reported mild symptoms, 2 points if they reported moderate symptoms, 3 points if they reported severe symptoms, and 4 points if they reported extremely severe symptoms.
Change from baseline score in Item 1 of the Menopause Rating Scale (MRS) at 6 months [3 months]
Item 1 considers the score obtained from hot flashes on the MRS scale. 0 points were assigned if the participants reported no symptoms, 1 point if they reported mild symptoms, 2 points if they reported moderate symptoms, 3 points if they reported severe symptoms, and 4 points if they reported extremely severe symptoms.

Secondary Outcome Measures

Change from the severity of individual Menopause Rating Scale (MRS) items at 6 months [6 months]
It considers the obtained score from individual MRS items. 0 points were assigned if the participants reported no symptoms, 1 point if they reported mild symptoms, 2 points if they reported moderate symptoms, 3 points if they reported severe symptoms, and 4 points if they reported extremely severe symptoms.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants who attended the climacteric consultation for the first time, without prior treatment of menopausal symptoms, and who met postmenopausal criteria.
Participants who met the criteria for vasomotor syndrome and score greater than 17 points in total MRS.
Participants without psychiatric pathology (psychiatric illnesses such as major depression, generalized anxiety disorder, among others).
Participants who agreed to participate and gave their written informed consent.

Exclusion Criteria:

Participants who had contraindications to receive serotonin reuptake inhibitors (SSRIs).
Participants who were receiving prior treatment for the postmenopausal or vasomotor syndrome.
Participants who did not agree to participate or sign the informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE	Mexico City		Mexico	07300

Sponsors and Collaborators

Hospital Regional 1o de Octubre
Universidad Nacional Autonoma de Mexico
National Polytechnic Institute, Mexico

Investigators

Study Director: Juan M Ocampo-Godinez, M.D., Ph.D., Tissue Bioengineering Laboratory, National Autonomous University of Mexico [UNAM]
Study Director: Patricia Loranca-Moreno, M.D., M.Sc., Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE
Principal Investigator: Alan Rios-Espinosa, M.D., Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE