The effect of rose vaginal gel on sexual function of postmenopausal women
Design
This study is a randomized clinical trial with a control group and a parallel design. This double-blinded, randomized study will be conducted on 44 eligible women. A random block is used for randomization and the participants are assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted in Kermanshah clinics, is double-blinded. Before starting the study, the sexual function questionnaire will be provided to the participants and then they will be taught how to use the ointment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: at least one year has passed since the last menstruation; Obtaining a score of 28 or more from the FSFI questionnaire.
Exclusion criteria: suffering from uterine bleeding or spotting; Vaginal infection requires treatment; Use of vaginal drugs or any lubricants at least 15 days before the study.
Intervention groups
For the intervention group, each participant will be given a 50-gram tube with an applicator, instructions for use, and a side effects registration form for use for 12 weeks. The method of consumption is every night for two weeks and the next ten weeks in the form of one gram twice a week. The control group will receive a placebo
Main outcome variables
Sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240630062289N1
Registration date:2024-07-12, 1403/04/22
Registration timing:prospective
Last update:2024-07-12, 1403/04/22
Update count:0
Registration date
2024-07-12, 1403/04/22
Registrant information
Name
Fatemeh Golnazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 936 825 3421
Email address
fatemehgolnazari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-05, 1403/05/15
Expected recruitment end date
2024-12-05, 1403/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of rose vaginal gel on sexual function of postmenopausal women: A clinical trial study
Public title
Investigating the effect of rose vaginal gel on sexual function of postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least one year has passed since the last menstrual period or having a hormone test with an FSH level greater than 40 international units
Obtaining a score of 28 or more from the FSFI questionnaire
Age between 45 and 65 years
Being married
Absence or history of uterine and breast cancer
Exclusion criteria:
Having uterine bleeding or spotting with an unknown cause
Vaginal infection requires treatment
Abnormalities of the genital system Under sex hormone therapy within 8 weeks before the study
Use of vaginal drugs or any lubricants at least 15 days before the study
Smoking (alcohol, cigarettes, hookah)
Body mass index more than 30 kg/m2
Cholestatic liver disorders, severe kidney failure, acute thromboembolism and high blood pressure
Age
From 45 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method will be used using blocks of 4. A third person who does not have any involvement in the process of taking patients and evaluating patients. Using the site: https://www.sealedenvelope.com will create a random sequence and based on the sample size, 15 blocks of 4 will be created. Each patient will be given a unique code that can be created on this site.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to hide the allocation of drug and placebo tubes, both groups, which are in the same package, are coded by the pharmacist with 2 codes. Code A for rose flower and code B for placebo, including people in the study and delivering the envelopes will be done by the researcher. Neither the patient nor the person evaluating the patient will know what medication has been received. Medicines are sealed and an arrangement will be adopted that only people of one group will visit on that day during re-evaluation. This will be planned by a statistical consultant who knows the codes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2024-05-28, 1403/03/08
Ethics committee reference number
IR.KUMS.REC.1403.099
Health conditions studied
1
Description of health condition studied
Sexual function
ICD-10 code
N95
ICD-10 code description
Menopausal and other perimenopausal disorders
Primary outcomes
1
Description
Sexual function
Timepoint
before the start of the study, 2, 6 and 12 weeks after the intervention
Method of measurement
Female Sexual Function Index (FSFI) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
For the intervention group, each participant will be given a 50-gram tube, which will be prepared by Renorm Tosan Darou Pharmaceutical Company, along with an applicator, instructions for use, and a side effect registration form for use for 12 weeks. The method of consumption is every night for two weeks and the next ten weeks in the form of one gram twice a week.
Category
Treatment - Drugs
2
Description
The control group will receive the placebo, which will be prepared by Renorm Tosan Darou Pharmaceutical Company.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafezia Clinic
Full name of responsible person
Dr. Susan Heydarpour
Street address
Kermanshah Hafezia
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
s.heydarpour1394@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Cyrus Jalili
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Susan Heydarpour
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3828 2101
Email
s.heydarpour1394@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Susan Heydarpour
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3828 2101
Email
s.heydarpour1394@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Susan Heydarpour
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3828 2101
Email
s.heydarpour1394@yahoo.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