Comparison of Fluoxetine Versus Citalopram Therapy to Control Postmenopausal Vasomotor Syndrome

July 25, 2022 updated by: Hospital Regional 1o de Octubre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 07300
        • Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Menopause Rating Scale (MRS) total score at 3 months
Time Frame: 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.
3 months
Change from baseline Menopause Rating Scale (MRS) total score at 6 months
Time Frame: 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.
6 months
Change from baseline Menopause Rating Scale (MRS) somatic domain score at 3 months
Time Frame: 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.
3 months
Change from baseline Menopause Rating Scale (MRS) somatic domain score at 6 months
Time Frame: 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.
6 months
Change from baseline Menopause Rating Scale (MRS) urogenital domain score at 3 months
Time Frame: 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.
3 months
Change from baseline Menopause Rating Scale (MRS) urogenital domain score at 6 months
Time Frame: 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.
6 months
Change from baseline Menopause Rating Scale (MRS) psychological domain score at 3 months
Time Frame: 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.
3 months
Change from baseline Menopause Rating Scale (MRS) psychological domain score at 6 months
Time Frame: 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.
6 months
Change from baseline score in Item 1 of the Menopause Rating Scale (MRS) at 3 months
Time Frame: 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.
3 months
Change from baseline score in Item 1 of the Menopause Rating Scale (MRS) at 6 months
Time Frame: 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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from the severity of individual Menopause Rating Scale (MRS) items at 6 months
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Regional 1o de Octubre

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2021

Primary Completion (Actual)

November 20, 2021

Study Completion (Actual)

December 20, 2021

Study Registration Dates

First Submitted

April 14, 2022

First Submitted That Met QC Criteria

April 20, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 122.2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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