Skip to content

Comparison of Fluoxetine Versus Citalopram Therapy to Control Postmenopausal Vasomotor Syndrome

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05346445
Enrollment
91
Registered
2022-04-26
Start date
2021-01-20
Completion date
2021-12-20
Last updated
2022-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopause, Hot Flashes

Keywords

Postmenopause, Fluoxetine, Menopause Rating Scale, Vasomotor syndrome, Urogenital syndrome, Citalopram, Non hormonal therapy, Non-hormonal therapies, Serotonin reuptake inhibitors

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.

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.

Interventions

Participants received non-hormonal treatment with fluoxetine.

Participants received non-hormonal treatment with citalopram.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline score in Item 1 of the Menopause Rating Scale (MRS) at 6 months3 monthsItem 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 Menopause Rating Scale (MRS) total score at 3 months3 monthsMenopause 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 months6 monthsMenopause 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 months3 monthsIt 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 months6 monthsIt 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 months3 monthsIt 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 months6 monthsIt 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 months3 monthsIt 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 months6 monthsIt 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 months3 monthsItem 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

MeasureTime frameDescription
Change from the severity of individual Menopause Rating Scale (MRS) items at 6 months6 monthsIt 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.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026