The aim of this study is to compare the effect of chamomile vaginal gel with Conjugated Estrogen on the treatment of vaginal atrophy in postmenopausal women.
Design
In this study 96 postmenopausal women with vaginal atrophy and have include criteria into the study, are randomly divided into two intervention groups and one control group.
Settings and conduct
Samples include postmenopausal women aged 45 to 65 with vaginal atrophy. The sample size is 96 and the duration of the intervention is 12 weeks. Researcher and volunteer Participation in this study is completely unaware from vaginal medications and placebo, and medications tubes fill with pharmacist.Vaginal medications are all in the same package and are coded by the pharmacist. Initially, patients are examined from the symptoms of vaginal atrophy and the questionnaire of mental symptoms of vaginal atrophy is completed by patients. then The vaginal discharge samples are taken for examination of the Vaginal mucosal cell maturation index. The pH of the vagina is also measured by a pH meter. Individuals are randomly assigned to one of three groups. One group (Vaginal Cream, Conjugate estrogen) another group (chamomile vaginal gel) and the control group (placebo vaginal gel) received at a dose of 1 mg for 12 weeks ( First two weeks every night and the next 10 weeks twice a week). End of weeks 2, 6, and 12 are evaluated for signs of vaginal atrophy.at the end of the study, the vaginal pH and vaginal discharge samples are examined.
Participants/Inclusion and exclusion criteria
include criteria: People who have had at least one year of their last menstruation or have a hormonal test with an average fsh> 40 international units
There are symptoms of vaginal atrophy
The age range is 45-65 years
Have sex and monogamy
exclude criteria: Vaginal infection needs treatment
Genital abnormalities
Hormone therapy or use sexual hormones during the 8 weeks prior to the study
Using vaginal medicines or any lubricant at least 15 days before the study
Tobacco use (alcohol, cigarette and hookah)
Breast diseases with unknown cause
Uterine bleeding or spotting with unspecified cause
Excessive consumption of phytoestrogens such as soy, red clover, fenugreek over the past month
BMI more than 30
Cholestatic Diseases of the Liver
Severe kidney failure
Acute Thrombophlebitis
High blood pressure
Intervention groups
One group (vaginal cream conjugate estrogen); another group( chamomile vaginal gel) and the control group (placebo vaginal gel)
Main outcome variables
Treatment of vaginal atrophy; Reducing the complications of vaginal atrophy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171218037943N1
Registration date:2018-01-21, 1396/11/01
Registration timing:registered_while_recruiting
Last update:2018-01-21, 1396/11/01
Update count:0
Registration date
2018-01-21, 1396/11/01
Registrant information
Name
Zahra Bosak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3636 3453
Email address
zahrabosak@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Chamomile vaginal gel with Conjugated Estrogen in the treatment of vaginal atrophy in postmenopausal women
Public title
Vaginal gel Chamomile and Conjugated Estrogen in the treatment of vaginal atrophy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People who have had at least one year of their last menstruation or have a hormonal test with an average fsh> 40 international units
There are symptoms of vaginal atrophy
The age range is 45-65 years
Have sex and monogamy
Exclusion criteria:
Vaginal infection needs treatment
Genital abnormalities
Hormone therapy or use of sexual hormones during the 8 weeks prior to the study
Using vaginal medicines or any lubricant at least 15 days before the study
Tobacco use (alcohol, cigarette and hookah)
Breast diseases with unknown cause
Uterine bleeding or spotting with unspecified cause
Excessive consumption of phytoestrogens such as soy, red clover, fenugreek over the past month
BMI more than 30
Cholestatic Diseases of the Liver
Severe kidney failure
Acute Thrombophlebitis
High blood pressure
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized numerical tables using computers. individually
Blinding (investigator's opinion)
Double blinded
Blinding description
Researcher and volunteer in this study completely unaware of the placebo or medications and medication tubes filled by the pharmacist.Vaginal medications are in the same package and are coded by the pharmacist.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Associate Professor of Research and Information Technology, Ahvaz Jundishapur University of Medical Sciences, Academic town, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2017-11-11, 1396/08/20
Ethics committee reference number
IR.AJUMS.REC.1396.729
Health conditions studied
1
Description of health condition studied
Vaginal Atrophy in Postmenopausal Women
ICD-10 code
N95.2
ICD-10 code description
Postmenopausal atrophic vaginitis
Primary outcomes
1
Description
vaginal atrophy
Timepoint
At the beginning of the study, 14, 42 and 84 days after Intervention
Method of measurement
Cooperman Index Questionnaire
2
Description
Percentage of vaginal cell maturation
Timepoint
Before intervention, after intervention
Method of measurement
Vaginal smear
3
Description
Vaginal acidity
Timepoint
Before intervention, after intervention
Method of measurement
PH gauge
Secondary outcomes
1
Description
Painful intercourse
Timepoint
At the beginning of the study, 14, 42 and 84 days after Intervention
Method of measurement
Self-assessment scale is 4 degrees
2
Description
Menopause symptoms
Timepoint
At the beginning of the study, 14, 42 and 84 days after Intervention
Method of measurement
Cooperman Index Questionnaire
3
Description
Severity of menopause symptoms
Timepoint
At the beginning of the study, 14, 42 and 84 days after Intervention
Method of measurement
Menopause Rating Scale
4
Description
Sexual performance
Timepoint
Before and after the intervention
Method of measurement
Female Sexual Function Index (FSFI)
5
Description
Sexual satisfaction
Timepoint
Before and after the intervention
Method of measurement
Larson Sexual Satisfaction Questionnaire
Intervention groups
1
Description
First intervention group: Vaginal Cream, Conjugated Estrogen ./625 Mg, one mg for 12 weeks (the first two weeks, each night and the next 10 weeks, two nights a week), Aburaihan Pharmacy Company
Category
Treatment - Drugs
2
Description
Two intervention group:chamomile vaginal gel 5%, one mg for 12 weeks (the first two weeks, each night and the next 10 weeks, two nights a week)
Category
Treatment - Drugs
3
Description
Control group: placebo vaginal gel, one mg for 12 weeks (the first two weeks, each night and the next 10 weeks, two nights a week)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center Number One
Full name of responsible person
Zahra Bosak
Street address
Imam street, Gotwand County
City
Gotvand
Province
Khouzestan
Postal code
64551-11637
Phone
+98 61 3632 6100
Email
zahrabosak@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badvi
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3336 1984
Email
itc@ajums.ac.ir
Web page address
http://behsan.ajums.ac.ir/
Grant name
Grant code / Reference number
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Bosak
Position
Masters Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3336 1984
Email
zahrabosak@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina Iravani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8396
Email
minairavani2004@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Bosak
Position
Masters Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3636 3453
Email
zahrabosak@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available