PostmenopauseNCT05346445
Comparison of Fluoxetine Versus Citalopram Therapy to Control Postmenopausal Vasomotor Syndrome
A study testing Fluoxetine 20 MG and Citalopram 20mg in people with Postmenopause and Hot Flashes, run by Hospital Regional 1o de Octubre at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postmenopause, Hot Flashes
- What is being tested?
- Fluoxetine 20 MG and Citalopram 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteMexico
- Study dates
- 20 Jan 2021to 20 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE
Mexico City, 07300
About this study
Official title: 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.
Read the 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.
- Conditions
- Postmenopause, Hot Flashes
- Being tested
- Fluoxetine 20 MG, Citalopram 20mg
- Keywords
- Postmenopause, Fluoxetine, Menopause Rating Scale, Vasomotor syndrome, Urogenital syndrome, Citalopram, Non hormonal therapy, Non-hormonal therapies, Serotonin reuptake inhibitors
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoxetine 20 MGDrug
Also called Generic PISA®
Participants received non-hormonal treatment with fluoxetine.
Citalopram 20mgDrug
Also called PREPRAM®
Participants received non-hormonal treatment with citalopram.
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine group | Active comparator | Participants received fluoxetine, 20 mg tablets, once a day for six months. Receives: Drug: Fluoxetine 20 MG |
| Citalopram group | Experimental | Participants received citalopram, 20 mg tablets, once a day for six months. Receives: Drug: Citalopram 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Menopause Rating Scale (MRS) total score at 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.
Measured: 3 months
Change from baseline Menopause Rating Scale (MRS) total score at 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.
Measured: 6 months
Change from baseline Menopause Rating Scale (MRS) somatic domain score at 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.
Measured: 3 months
Change from baseline Menopause Rating Scale (MRS) somatic domain score at 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.
Measured: 6 months
Change from baseline Menopause Rating Scale (MRS) urogenital domain score at 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.
Measured: 3 months
Change from baseline Menopause Rating Scale (MRS) urogenital domain score at 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.
Measured: 6 months
Change from baseline Menopause Rating Scale (MRS) psychological domain score at 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.
Measured: 3 months
Change from baseline Menopause Rating Scale (MRS) psychological domain score at 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.
Measured: 6 months
Change from baseline score in Item 1 of the Menopause Rating Scale (MRS) at 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.
Measured: 3 months
Change from baseline score in Item 1 of the Menopause Rating Scale (MRS) at 6 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.
Measured: 3 months
Secondary outcomes (1)
Change from the severity of individual Menopause Rating Scale (MRS) items at 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start20 Jan 2021
- Primary completion20 Nov 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for PostmenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Regional 1o de Octubre
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico, National Polytechnic Institute, Mexico
- Responsible party
- Sponsor
- Investigators
- Juan M Ocampo-Godinez, M.D., Ph.D., Study director, Tissue Bioengineering Laboratory, National Autonomous University of Mexico [UNAM]Patricia Loranca-Moreno, M.D., M.Sc., Study director, Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTEAlan Rios-Espinosa, M.D., Principal investigator, Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346445
- Sponsor's protocol ID
- 122.2021
- Status last verified
- Jul 2022
- First submitted
- 14 Apr 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El Khoudary SR, McClure CK, VoPham T, Karvonen-Gutierrez CA, Sternfeld B, Cauley JA, Khalil N, Sutton-Tyrrell K. Longitudinal assessment of the menopausal transition, endogenous sex hormones, and perception of physical functioning: the Study of Women's Health Across the Nation. J Gerontol A Biol Sci Med Sci. 2014 Aug;69(8):1011-7. doi: 10.1093/gerona/glt285. Epub 2014 Jan 24.
PubMed 24465026Jones CM, Boelaert K. The Endocrinology of Ageing: A Mini-Review. Gerontology. 2015;61(4):291-300. doi: 10.1159/000367692. Epub 2014 Nov 27.
PubMed 25471682Blumel JE, Lavin P, Vallejo MS, Sarra S. Menopause or climacteric, just a semantic discussion or has it clinical implications? Climacteric. 2014 Jun;17(3):235-41. doi: 10.3109/13697137.2013.838948. Epub 2013 Nov 7.
PubMed 23998690Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause - global prevalence, physiology and implications. Nat Rev Endocrinol. 2018 Apr;14(4):199-215. doi: 10.1038/nrendo.2017.180. Epub 2018 Feb 2.
PubMed 29393299Kim MJ, Yim G, Park HY. Vasomotor and physical menopausal symptoms are associated with sleep quality. PLoS One. 2018 Feb 20;13(2):e0192934. doi: 10.1371/journal.pone.0192934. eCollection 2018.
PubMed 29462162Sarrel P, Portman D, Lefebvre P, Lafeuille MH, Grittner AM, Fortier J, Gravel J, Duh MS, Aupperle PM. Incremental direct and indirect costs of untreated vasomotor symptoms. Menopause. 2015 Mar;22(3):260-6. doi: 10.1097/GME.0000000000000320.
PubMed 25714236Avis NE, Crawford SL, Green R. Vasomotor Symptoms Across the Menopause Transition: Differences Among Women. Obstet Gynecol Clin North Am. 2018 Dec;45(4):629-640. doi: 10.1016/j.ogc.2018.07.005. Epub 2018 Oct 25.
PubMed 30401547Langer RD, Hodis HN, Lobo RA, Allison MA. Hormone replacement therapy - where are we now? Climacteric. 2021 Feb;24(1):3-10. doi: 10.1080/13697137.2020.1851183. Epub 2021 Jan 6.
PubMed 33403881Deecher DC, Dorries K. Understanding the pathophysiology of vasomotor symptoms (hot flushes and night sweats) that occur in perimenopause, menopause, and postmenopause life stages. Arch Womens Ment Health. 2007;10(6):247-57. doi: 10.1007/s00737-007-0209-5. Epub 2007 Dec 12.
PubMed 18074100De Franciscis P, Cobellis L, Fornaro F, Sepe E, Torella M, Colacurci N. Low-dose hormone therapy in the perimenopause. Int J Gynaecol Obstet. 2007 Aug;98(2):138-42. doi: 10.1016/j.ijgo.2007.04.008. Epub 2007 Jun 18.
PubMed 17572422Stubbs C, Mattingly L, Crawford SA, Wickersham EA, Brockhaus JL, McCarthy LH. Do SSRIs and SNRIs reduce the frequency and/or severity of hot flashes in menopausal women. J Okla State Med Assoc. 2017 May;110(5):272-274.
PubMed 28649145Kapoor E, Faubion S, Hurt RT, Fischer K, Schroeder D, Fokken S, Croghan IT. A selective serotonin receptor agonist for weight loss and management of menopausal vasomotor symptoms in overweight midlife women: a pilot study. Menopause. 2020 Nov;27(11):1228-1235. doi: 10.1097/GME.0000000000001599.
PubMed 33110038Ensrud KE, Joffe H, Guthrie KA, Larson JC, Reed SD, Newton KM, Sternfeld B, Lacroix AZ, Landis CA, Woods NF, Freeman EW. Effect of escitalopram on insomnia symptoms and subjective sleep quality in healthy perimenopausal and postmenopausal women with hot flashes: a randomized controlled trial. Menopause. 2012 Aug;19(8):848-55. doi: 10.1097/gme.0b013e3182476099.
PubMed 22433978Wroolie TE, Williams KE, Keller J, Zappert LN, Shelton SD, Kenna HA, Reynolds MF, Rasgon NL. Mood and neuropsychological changes in women with midlife depression treated with escitalopram. J Clin Psychopharmacol. 2006 Aug;26(4):361-6. doi: 10.1097/01.jcp.0000227699.26375.f8.
PubMed 16855452Shams T, Firwana B, Habib F, Alshahrani A, Alnouh B, Murad MH, Ferwana M. SSRIs for hot flashes: a systematic review and meta-analysis of randomized trials. J Gen Intern Med. 2014 Jan;29(1):204-13. doi: 10.1007/s11606-013-2535-9. Epub 2013 Jul 26.
PubMed 23888328
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Citalopram Improves Vasomotor and Urogenital Syndromes in Mexican Patients With Post-menopause
- ClinicalTrials.gov ID
- NCT05346445
- Acronym / sponsor ID
- 122.2021
- Conditions
- Postmenopause, Hot Flashes
- Keywords
- Postmenopause, Fluoxetine, Menopause Rating Scale, Vasomotor syndrome, Urogenital syndrome, Citalopram, Non hormonal therapy, Non-hormonal therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Hospital Regional 1o de OctubreUniversity, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico, National Polytechnic Institute, Mexico
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fluoxetine group | Active comparator | Drug: Fluoxetine 20 MGParticipants received fluoxetine, 20 mg tablets, once a day for six months. |
| Citalopram group | Experimental | Drug: Citalopram 20mgParticipants received citalopram, 20 mg tablets, once a day for six months. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoxetine 20 MGAlso: Generic PISA®Participants received non-hormonal treatment with fluoxetine. | Drug | Fluoxetine group |
| Citalopram 20mgAlso: PREPRAM®Participants received non-hormonal treatment with citalopram. | Drug | Citalopram group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
1 secondary outcome
Change from the severity of individual Menopause Rating Scale (MRS) items at 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Background: PubMed 24465026El Khoudary SR, McClure CK, VoPham T, Karvonen-Gutierrez CA, Sternfeld B, Cauley JA, Khalil N, Sutton-Tyrrell K. Longitudinal assessment of the menopausal transition, endogenous sex hormones, and perception of physical functioning: the Study of Women's Health Across the Nation. J Gerontol A Biol Sci Med Sci. 2014 Aug;69(8):1011-7. doi: 10.1093/gerona/glt285. Epub 2014 Jan 24.
- Background: PubMed 25471682Jones CM, Boelaert K. The Endocrinology of Ageing: A Mini-Review. Gerontology. 2015;61(4):291-300. doi: 10.1159/000367692. Epub 2014 Nov 27.
- Background: PubMed 23998690Blumel JE, Lavin P, Vallejo MS, Sarra S. Menopause or climacteric, just a semantic discussion or has it clinical implications? Climacteric. 2014 Jun;17(3):235-41. doi: 10.3109/13697137.2013.838948. Epub 2013 Nov 7.
- Background: PubMed 29393299Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause - global prevalence, physiology and implications. Nat Rev Endocrinol. 2018 Apr;14(4):199-215. doi: 10.1038/nrendo.2017.180. Epub 2018 Feb 2.
- Background: PubMed 29462162Kim MJ, Yim G, Park HY. Vasomotor and physical menopausal symptoms are associated with sleep quality. PLoS One. 2018 Feb 20;13(2):e0192934. doi: 10.1371/journal.pone.0192934. eCollection 2018.
- Background: PubMed 25714236Sarrel P, Portman D, Lefebvre P, Lafeuille MH, Grittner AM, Fortier J, Gravel J, Duh MS, Aupperle PM. Incremental direct and indirect costs of untreated vasomotor symptoms. Menopause. 2015 Mar;22(3):260-6. doi: 10.1097/GME.0000000000000320.
- Background: PubMed 30401547Avis NE, Crawford SL, Green R. Vasomotor Symptoms Across the Menopause Transition: Differences Among Women. Obstet Gynecol Clin North Am. 2018 Dec;45(4):629-640. doi: 10.1016/j.ogc.2018.07.005. Epub 2018 Oct 25.
- Background: PubMed 33403881Langer RD, Hodis HN, Lobo RA, Allison MA. Hormone replacement therapy - where are we now? Climacteric. 2021 Feb;24(1):3-10. doi: 10.1080/13697137.2020.1851183. Epub 2021 Jan 6.
- Background: PubMed 18074100Deecher DC, Dorries K. Understanding the pathophysiology of vasomotor symptoms (hot flushes and night sweats) that occur in perimenopause, menopause, and postmenopause life stages. Arch Womens Ment Health. 2007;10(6):247-57. doi: 10.1007/s00737-007-0209-5. Epub 2007 Dec 12.
- Background: PubMed 17572422De Franciscis P, Cobellis L, Fornaro F, Sepe E, Torella M, Colacurci N. Low-dose hormone therapy in the perimenopause. Int J Gynaecol Obstet. 2007 Aug;98(2):138-42. doi: 10.1016/j.ijgo.2007.04.008. Epub 2007 Jun 18.
- Background: PubMed 28649145Stubbs C, Mattingly L, Crawford SA, Wickersham EA, Brockhaus JL, McCarthy LH. Do SSRIs and SNRIs reduce the frequency and/or severity of hot flashes in menopausal women. J Okla State Med Assoc. 2017 May;110(5):272-274.
- Background: PubMed 33110038Kapoor E, Faubion S, Hurt RT, Fischer K, Schroeder D, Fokken S, Croghan IT. A selective serotonin receptor agonist for weight loss and management of menopausal vasomotor symptoms in overweight midlife women: a pilot study. Menopause. 2020 Nov;27(11):1228-1235. doi: 10.1097/GME.0000000000001599.
- Individual participant dataSharing planned: No
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Frozen Shoulder, Adhesive Capsulitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan M Ocampo-Godinez, M.D., Ph.D. study director
Tissue Bioengineering Laboratory, National Autonomous University of Mexico [UNAM]
Patricia Loranca-Moreno, M.D., M.Sc. study director
Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE
Alan Rios-Espinosa, M.D. principal investigator
Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoxetine 20 MG and Citalopram 20mg in people with Postmenopause and Hot Flashes, run by Hospital Regional 1o de Octubre at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Menopause Rating Scale (MRS) total score at 3 months (time frame: 3 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05346445, which also lists 41 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.