Objectives: To compare the effects of Paroxetine and Gabapentin in the treatment of hot flashes in menopausal women Design: Randomized, single-blind, single-center, phase II clinical trial. Postmenopausal women with hot flushes are divided into two treatment groups: Paroxetine and Gabapentin to reduce the symptoms of hot flashes. In the group treated with Gabapentin, they will receive 600 mg capsules of Gabapentin daily for up to 8 weeks (56 days). Patients in the Paroxetine group will receive one Paroxetine capsule in the morning or before bed for 8 weeks (56 days). The amount of hot flashes is measured before and after treatment. The main inclusion criteria included: The Women who have hot flashes with sweats on average 7 times or more and have menstrual periods cessation for more than 12 months. Exclusion criteria included: Women with a history of chemotherapy; radiation therapy; depression; systemic diseases; liver disease; cancer and diseases that cause hormonal disorders. Interventions: Patients are divided into two treatment groups: paroxetine and gabapentin. In the group treated with gabapentin, they will receive 600 mg capsules of gabapentin daily for up to 8 weeks (56 days). Patients in the paroxetine group will receive one paroxetine capsule in the morning or before bed for 8 weeks (56 days). Main outcome: The amount of hot flashes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201704143461N8
Registration date:2017-10-22, 1396/07/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-22, 1396/07/30
Registrant information
Name
Firoozeh Veisi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1823 4276
Email address
f_veisi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-05-10, 1396/02/20
Expected recruitment end date
2017-06-09, 1396/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effects of paroxetine and gabapentin in the treatment of hot flashes in postmenopausal women
Public title
Effects of paroxetine and gabapentin on hot flashes in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The Women who have hot flashes with sweats on average 7 times or more and have more than 12 months of menstrual cessation. Exclusion criteria: Women with a history of chemotherapy; radiation therapy; depression; systemic diseases; liver disease; cancer and diseases that cause hormonal disorders.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for research، Building No. 2, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah University of Medical Sciences, Kermanshah
Postal code
Approval date
2015-05-04, 1394/02/14
Ethics committee reference number
IR.kums.rec.1395.9310109009
Health conditions studied
1
Description of health condition studied
Flushing
ICD-10 code
R23.2
ICD-10 code description
Flushing
Primary outcomes
1
Description
Flushing
Timepoint
Before and after treatment
Method of measurement
Based on MRS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Group A: Each day, up to 8 weeks (a 56-day course), received 600 mg capsule of gabapentin.
Category
Treatment - Drugs
2
Description
Group B: Each day, up to 8 weeks (a 56-day course), received 600 mg capsule of paroxetine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza (AS) Hospital
Full name of responsible person
Firouzeh Veisi
Street address
Department of obstetrics and gynecology, Imam Reza Hospital, Sorkhalizheh
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Behrouz Hamzeh
Street address
Vice Chancellor for research، Building No. 2, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Firozeh Vaysi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of obstetrics and gynecology, Imam Reza Hospital, Sorkhalizheh.
City
Kermanshah
Postal code
Phone
+98 83 3427 6309
Fax
Email
f_veisi@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Firozeh Vaysi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of obstetrics and gynecology, Imam Reza Hospital, Sorkhalizheh.
City
Kermanshah
Postal code
Phone
+98 83 3427 6309
Fax
Email
f_veisi@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical sciences
Full name of responsible person
Tabasom Azadian
Position
Rezident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Department of obstetrics and gynecology, Imam Reza Hospital, Sorkhalizheh.
City
Kermanshah
Postal code
Phone
+98 83 3427 6309
Fax
Email
firoozehveisi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)