Comparison of the Effects of Vaginal Honey Jelly with Vaginal Lubricant Gel on Atrophic vaginitis symptoms and Quality of life in Post menopausal Women with Endometrial cancer
Comparison of the Effects of Vaginal Honey Jelly with Vaginal Lubricant Gel on Atrophic vaginitis symptoms and Quality of life in Post menopausal Women with Endometrial cancer to improve life quality in women with endometrial cancer
Design
This study Will be a Single-blind randomized controlled clinical trial two arm parallel, that will be done on 64 postmenopausal women with endometrial cancer referred to Women clinics of KOSAR Hospital of Urmia.
After accepting the study, they will be divided in two groups using vaginal lubricant jelly or vaginal Honey Gel, based on Even and Odd days.
Settings and conduct
The study will be done on 64 postmenopausal women with endometrial cancer referred to Women clinics of KOSAR Hospital of Urmia.
After accepting the study, they will be divided in two groups containing 32 subjects; using vaginal lubricant jelly or vaginal Honey Gel, based on Even and Odd days.
Data will be collected using two forms of questionnaire. The Menopause-specific Quality of Life (MENQOL) questionnaire and VSQ questionnaire.The questionnaires will be completed pre- and post-intervention period by a person who is not involved in to the study as a personal interview.
Patients and all persons who collect data and analyze them will be unaware of the type of medication prescribed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: At least 12 months of amenorrhea; Symptoms of atrophic vaginitis; History of endometrial cancer
Exclusion criteria: Dissatisfaction to participate in the study; Allergy to Honey
Intervention groups
First group: Using Vaginal Honey Gel
Second group: Using Vaginal Lubricant Jelly
Main outcome variables
Improvement of symptoms of atrophic vaginitis in women with endometrial cancer.
Improvement of Life style in women with endometrial cancer.
Improvement of vasomotor symptoms in women with endometrial cancer.
Improvement of sexual complications in women with endometrial cancer.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180211038692N1
Registration date:2018-03-03, 1396/12/12
Registration timing:registered_while_recruiting
Last update:2018-03-03, 1396/12/12
Update count:0
Registration date
2018-03-03, 1396/12/12
Registrant information
Name
Samira Mirzaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3330 2171
Email address
samira.mirzaei.dr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-08, 1396/11/19
Expected recruitment end date
2018-04-08, 1397/01/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Vaginal Honey Jelly with Vaginal Lubricant Gel on Atrophic vaginitis symptoms and Quality of life in Post menopausal Women with Endometrial cancer
Public title
Effects of Vaginal Honey Gel in Endometrial Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least 12 months of amenorrhea
Symptoms of vaginal atrophy
History of Endometrial cancer
Exclusion criteria:
Dissatisfaction to participate in the study
Allergy to honey
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
64
Actual sample size reached:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
After accepting to contribute in this clinical trial, women will be divided in 2 groups based on even and odd days, using vaginal lubricant jelly or vaginal honey gel.
Patients will be unaware of the type of medication prescribed.
The questionnaire will be completed pre and post-intervention period by a person who is not involved in to the study as personal interview.
Data collection and analyzes will be done by a person who is not involved in to the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Science
Street address
Motahhari Hospital., Kashani Ave., Urmia., West Azarbayjan
City
Urmia
Province
West Azarbaijan
Postal code
5715615463
Approval date
2018-01-29, 1396/11/09
Ethics committee reference number
IR.UMSU.REC.1396.366
Health conditions studied
1
Description of health condition studied
Atrophic vaginitis
ICD-10 code
N95.2
ICD-10 code description
Postmenopausal atrophic vaginitis
Primary outcomes
1
Description
The score of atrophic vaginitis
Timepoint
Filling the questionnaire at fist and 2 months after intervention
Method of measurement
MENQOL questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Using Vaginal Honey Gel
Category
Treatment - Drugs
2
Description
Intervention group: Using Vaginal Lubricant Jelly
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahhari Hospital
Full name of responsible person
Maryam Yusefi
Street address
Motahhari Hospital., Kashani Ave., Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715615463
Phone
+98 44 3222 4777
Fax
Email
Samira.mirzaei.dr@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Motahhari Hospital., Kashani Ave., Urmia., West Azarbayjan
City
Urmia
Province
West Azarbaijan
Postal code
575615463
Phone
+98 44 3222 4777
Email
Samira.mirzaei.dr@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Samira Mirzaei
Position
Resident of Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Motahhari Hospital., Kashani Ave., Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715615463
Phone
+98 44 3222 4777
Email
Samira.mirzaei.dr@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Samira Mirzaei
Position
Residnt of Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Motahhari Hospital, Kashani Ave, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715615463
Phone
+98 44 3222 4777
Email
Samira.mirzaei.dr@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Samira Mirzaei
Position
Resident of Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Motahhari Hospital, Kashani Ave, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715615463
Phone
+98 44 3222 4777
Email
Samira.mirzaei.dr@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD