The aim of this study is to determine the effect of vitamin D vaginal suppository on vaginal atrophy in menopause women. Women enrolled in the study if they are between 44 and 64 years of age with post menopausal at least for one year after the last menstruation. They have excluded from the study if they recieve hormonal treatment or intravaginal drug.This study is a double-blind clinical trial and forty-four women selected randomly and divided to two groups. Treatment group received the vitamin D3 200 IU vaginal suppository and control group recieved plasbo vaginal suppository in 8 weeks. They use it every night in first two weeks and every other day in later six-weeks.Vaginal dryness and pale vaginal wall will assesse in first visit, 2, 4 and 8 weeks. Ph and maturation index measure by ph meter and vaginal pop smear respectively, in first visit and eight week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111158109N1
Registration date:2012-02-04, 1390/11/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-02-04, 1390/11/15
Registrant information
Name
Hamdollah Delaviz
Name of organization / entity
Yasuj University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 2223 5135
Email address
delaviz.h@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University of Medical Sciences
Expected recruitment start date
2010-07-27, 1389/05/05
Expected recruitment end date
2012-02-26, 1390/12/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Vitamin D vaginal suppository on vaginal atrophy in postmenopausal women
Public title
The effect of Vitamin D vagi on vaginal atrophy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged between 16 - 64 years; Laboratory confirmation of menopause; at least one year after the last menstruation.
Exclusion criteria: hormonal treatment; intravaginal drug; existence of vaginal infection.
Age
From 44 years old to 64 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz University of Medical Sciences
Street address
Golestan highway, Ahvaz Medical Jondi-Shapour University
City
Ahvaz
Postal code
6135715794
Approval date
2011-09-19, 1390/06/28
Ethics committee reference number
Eth-312
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
Maturation index
Timepoint
two timews, the first and last visit
Method of measurement
pap smear
Secondary outcomes
1
Description
PH
Timepoint
PH
Method of measurement
PH meter
Intervention groups
1
Description
Treatment group received the vitamin D 200 IU vaginal suppository in 8 weeks. They use it every night in first two weeks and every other day in later six-weeks.
Category
Placebo
2
Description
Control group recieved plasbo vaginal suppository in 8 weeks. They use it every night in first two weeks and every other day in later six-weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hifdah septamber treatment center
Full name of responsible person
Parastou Rad
Street address
keharrah Abadan, kandomkar street
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
DR Mostafa Fefgehi
Street address
Golestan high way, Ahvaz University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
B-90/0020
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 University of Medical Sciences
Full name of responsible person
Parastou rad
Position
Ms.C student
Other areas of specialty/work
Street address
Yasuj, Emam sajad hospital, Delivery
City
Yasuj
Postal code
7591994799
Phone
+98 74 1334 4344
Fax
+98 74 1223 5153
Email
parastou.rad@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parastou rad
Position
Ms.C student
Other areas of specialty/work
Street address
Yasuj, Emam sajad hospital, Medical school, Anatomy Department Delaviz