Introduction: The aim of this study was to compare the effectiveness of the vaginal suppository of hyaloronic acid and vitamin E for the treatment of atrophic vaginitis. Material and Method: This randomized, double-blind, comparison study was carried out at East Ahvaz number one health center. Inclusion criteria include: Presenting symptom of vaginal atrophy, Superficial vaginal cells with 5% or less, Vaginal pH more than 5. Exclusion criteria include: Genital Bleeding of unknown Cause, The use of Sex Hormones within the 8 weeks preceding study. Forty postmenopausal women with symptoms of vaginal atrophy were randomized in two group to take vaginal suppositories of 5 mg hyaloronic acid sodium salt (n=20) or 1 mg vitamin E (n=20) for 8 weeks. The symptoms of vaginal atrophy were evaluated by a self-assessed 4-point scale of composite score was determined as, none, mild, moderate and severe. Vaginal pH and maturation value were measured and compared in both the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105026364N1
Registration date:2011-07-13, 1390/04/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-13, 1390/04/22
Registrant information
Name
Sara Ziagham
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 7543
Email address
ziagham.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahwaz University of Medical Sciences
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-01-16, 1389/10/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of Hyaluronic Acid Vaginal Suppository with Vitamin E in the Treatment of Atrophic Vaginits in Menopausal Women
Public title
Non Hormonal Treatment of Vaginal Atrophy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 45 to 65, Amenorrhea at less 12 month or have hormone test with FSH level more than 40 unit, Presence of normal pap smears, Presenting symptom of vaginal atrophy, Vaginal pH more than 5, Superficial vaginal cells with 5% or less, Have Sexual activity
Exclusion criteria: Vaginal infection, Genital Abnormalities, The use of Sex Hormones within the 8 weeks preceding study, Genital Bleeding of unknown Cause, Use of Phytoestrogens such as Soy, Red clover, Fenugreek, Vitex within the last one
Month
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Commettee of Ahvaz Jundishapur University of Medical Science
Street address
Department of Research and Information Technology University of Medical Sciences, Ahwaz Jondishapour, Ground Floor, City University, Ahvaz
City
Ahvaz
Postal code
6135715794
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
u-89163
Health conditions studied
1
Description of health condition studied
Vaginal Atrophy
ICD-10 code
N95.2
ICD-10 code description
Postmenopausal Atrophic Vaginitis
Primary outcomes
1
Description
Symptoms of Vaginal Atrophy
Timepoint
Before intervention, Two weeks after the intervention, Four weeks after intervention, Eight weeks after intervention
Method of measurement
Composite Score of Vaginal Symptoms
Secondary outcomes
1
Description
Vaginal Superficial Cells
Timepoint
after intervention, Two months after intervention
Method of measurement
Vaginal Cells Maturation Index
2
Description
Vaginal pH
Timepoint
Before intervention, Two months after intervention
Method of measurement
pH Test
Intervention groups
1
Description
Hyaloronic Acid, Vaginal Suppositories of 5 mg single for 2 months
Category
Treatment - Drugs
2
Description
Vitamin E, Vaginal Suppositories of 1 mg single for 2 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz East Number One Health Center
Full name of responsible person
Sara Ziagham
Street address
No. 34, Danesh Avenue, District 3. Bahonar, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Jondi Shapur Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Jondi Shapur Ahwaz University of Medical Sciences, opposite the central building, Vice Chancellor for Research, Ahwaz University of Medical Sciences, Ahvaz
City
Ahvaz
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, Jondi Shapur Ahvaz 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
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Sara Ziagham
Position
Graduate Student
Other areas of specialty/work
Street address
Jondi Shapur Ahwaz University of Medical Sciences, School of Nursing and Midwifery, a city college, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1227 2990
Fax
Email
Ziagham.s@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Zahra Abbaspoor
Position
Master Science
Other areas of specialty/work
Street address
Jondi Shapur Ahwaz University of Medical Sciences, School of Nursing and Midwifery, a city college, Ahvaz
City
Ahvaz
Postal code
6135715794
Phone
+98 61 1373 8394
Fax
Email
Abbaspoor_z762@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Sara Ziagham
Position
Graduate Student
Other areas of specialty/work
Street address
Jondi Shapur Ahwaz University of Medical Sciences, Ground Floor, Department of Research and Technology University of Medical Sciences, Ahwaz Jondishapour, a city college, Ahvaz
City
Ahvaz
Postal code
6135715794
Phone
+98 61133333477
Fax
+98 61 1336 1544
Email
www.ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)