Comparison of Fluoxetine Versus Citalopram Therapy to Control Postmenopausal Vasomotor Syndrome
NCT ID: NCT05346445
Last Updated: 2022-07-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
91 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-01-20
Study Completion Date
2021-12-20
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Postmenopause
Hot Flashes
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Fluoxetine group
Participants received fluoxetine, 20 mg tablets, once a day for six months.
Group Type
ACTIVE_COMPARATOR
Fluoxetine 20 MG
Intervention Type
DRUG
Participants received non-hormonal treatment with fluoxetine.
Citalopram group
Participants received citalopram, 20 mg tablets, once a day for six months.
Group Type
EXPERIMENTAL
Citalopram 20mg
Intervention Type
DRUG
Participants received non-hormonal treatment with citalopram.
Interventions
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Fluoxetine 20 MG
Participants received non-hormonal treatment with fluoxetine.
Intervention Type
DRUG
Citalopram 20mg
Participants received non-hormonal treatment with citalopram.
Intervention Type
DRUG
Other Intervention Names
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Generic PISA®
PREPRAM®
Eligibility Criteria
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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.
* 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.
* Participants who were receiving prior treatment for the postmenopausal or vasomotor syndrome.
* Participants who did not agree to participate or sign the informed consent.
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Universidad Nacional Autonoma de Mexico
OTHER
Sponsor Role
collaborator
National Polytechnic Institute, Mexico
OTHER
Sponsor Role
collaborator
Hospital Regional 1o de Octubre
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Juan M Ocampo-Godinez, M.D., Ph.D.
Role: STUDY_DIRECTOR
Tissue Bioengineering Laboratory, National Autonomous University of Mexico [UNAM]
Patricia Loranca-Moreno, M.D., M.Sc.
Role: STUDY_DIRECTOR
Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE
Alan Rios-Espinosa, M.D.
Role: PRINCIPAL_INVESTIGATOR
Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE
Locations
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Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE
Mexico City, , Mexico
Site Status
Countries
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Mexico
References
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Reference Type
DERIVED
Other Identifiers
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122.2021
Identifier Type: -
Identifier Source: org_study_id
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