This randomized single blind placebo controlled clinical trial will be conducted on sixty menopausal women, who elapse from their last menstruation at least one year and FSH level more than 40 IU/L. Exclusion criteria are: consumption of any drugs for flushing , having systemic diseases, happening the Gabapentin complications noncompliance .The aim of this study is to evaluate the efficacy of Gabapentin on the severity of flushing. The patients will randomly assign into intervention and control groups. In intervention group patients will take Gabapentin capsules (300mg), three times a day, for three months. The control group will receive placebo capsules (consist of starch) three times a day for three months. Primary outcome measure is the severity of flushing measured by visual analog scale at the beginning , first, second and third months after drug consumption. The results will be compared in study groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103011107N4
Registration date:2011-05-05, 1390/02/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-05, 1390/02/15
Registrant information
Name
Tajea Jadery
Name of organization / entity
Jundi shapur university
Country
Iran (Islamic Republic of)
Phone
-
Email address
research@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jundshapour University of Medical Sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2010-10-23, 1389/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized placebo controlled clinical trial of the efficacy of Gabapentin on flushing in menopausal women
Public title
Efficacy of Gabapentin on flushing in menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :
Elapsing one year of last menstrual phase(LMP), Follicle-stimulating hormone (FSH) more than 40IU/L and not using any drugs that affect on hot flush symptoms.
Exclusion criteria : happening Gabapentin side effects, noncompliance and coexistence of systemic disease
Age
From 40 years old to 55 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz Jondishapur University of Medical Sciences
Street address
Ahwaz
City
Golestan Bolvar,Ahvaz
Postal code
Approval date
2010-06-07, 1389/03/17
Ethics committee reference number
2380
Health conditions studied
1
Description of health condition studied
Flushing
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Flushing severity
Timepoint
Before intervention, 1 month after intervention, 2months later and 3 months later after intervention
Method of measurement
Visual Analoge Scale
Secondary outcomes
1
Description
Flushing duration
Timepoint
Before intervention, 1 month after intervention, 2months later and 3 months later after intervention