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Ethics committees
#1
2020-06-14, 1399/03/25
2020-06-21, 1399/04/01
2020-06-1421 00:00:00
Protocol summary
Study aim
Comparison of the effect of licorice vaginal cream and estrogen vaginal cream on the sexual function of postmenopausal women
Design
Clinical trial without control group, with two intervention groups, with parallel, randomized groups, phase 2 on 82 patients. Randomization was performed manually using the book Design and Analysis of a Clinical Trial by Joseph Philis, published in Willie Publications.
Settings and conduct
The study was conducted by referring to 7 health centers in Ilam and selecting postmenopausal women with sexual function problems. Visit to a gynecologist on days 1 (first day of referral and administration of the first dose of the drug), 14 (after the end of the first dose of the drug), 26 (ten days after the rest period, administration of the second dose of the drug), 40 (after re-use of the drug) , 60 (2 months after the start of the first visit). The questionnaire will be completed on days 1 (first day of referral and before the intervention), 30 (one month after the start of the intervention), 60 (two months later).
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- At least one year has passed since the onset of menopause and a maximum of 8 years since the onset of menopause, 2-Gynecologist confirms that menopause must have occurred, 3- Vaginal atrophy symptoms (dryness, paleness and Dyspareunia), 4- Married women, 5-Having sex at least twice a month during the study, 6- Reading and writing literacy, 7- Body mass index between 20 and 30, 8- Sexual dysfunction
Exclusion criteria: 1- Treatment with hormonal drugs,
2. Mental illness in the participant or his / her spouse, 3. Presence of underlying disease such as depression, cancers, pulmonary embolism, diabetes, 4. Taking anticholinergic drugs
Intervention groups
Study has two intervention groups, each with 41 members.
Main outcome variables
Sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200608047695N1
Registration date:2022-01-20, 1400/10/30
Registration timing:retrospective
Last update:2022-02-25, 1400/12/06
Update count:2
Registration date
2022-01-20, 1400/10/30
Registrant information
Name
parisa ahmadizad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 7567
Email address
p.ahmadizaddd@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-20, 1399/04/30
Expected recruitment end date
2020-11-18, 1399/08/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of licorice vaginal cream and estrogen vaginal cream on the sexual function of postmenopausal women
Public title
Comparison of the effect of licorice vaginal cream and estrogen vaginal cream on the sexual function of postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- At least one year has passed since the onset of menopause and a maximum of 8 years since the onset of menopause
Gynecologist confirms that menopause must have occurred
Vaginal atrophy symptoms (dryness, paleness and Dyspareunia)
Married womens
Have sex at least 2 times a month during research
Literacy for reading and writing
Body mass index between 20 and 30
Sexual dysfunction
Exclusion criteria:
Treatment with hormonal drugs
Mental illness in the participant or his / her spouse
Underlying diseases such as depression, cancers, pulmonary embolism, diabetes
Taking anticholinergic drugs
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the finite randomization method because we want the study groups to have an equal sample size. One of the methods used for finite randomization is the block method. In this study, we use the quadratic block method. The four blocks will consist of two participants in the estrogen group and two participants in the licorice group. And the execution method will be that the possible modes for a block of 4 are 6 modes: a. aabb b. abab ج. abba د. bbaa ه. baba خ. baab and to generate random numbers, we use the online kitset software, by first registering the required values from 1 to 6 (number of numbers 6), and we repeat this 4 times, but in the fourth time the number We put the numbers instead of 6, 2, because in the first 3 times we have produced 18 numbers, and in the last step only 2 more numbers are needed, and thus 20 random numbers between 1 and 6 are produced, which indicate 4 blocks. According to each number, the treatment allocation list is determined. According to the number of samples, which is 82 people, we form 20 blocks of 4 and the last 2 people are randomly divided into two groups. (A = estrogen group, b = licorice group)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ilam University of Medical Sciences
Street address
Tajarian6, Tajatian street, Chalimar
City
Ilam
Province
Ilam
Postal code
6931156381
Approval date
2020-06-21, 1399/04/01
Ethics committee reference number
IR.MEDILAM.REC.1399.118
Health conditions studied
1
Description of health condition studied
Sexual function of postmenopausal women
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Sexual function
Timepoint
During the study (first day of referral, 30 days after the start of the intervention, 60 days after the start of the intervention)
Method of measurement
Female Sexual function Index Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention Group: Receipt of vaginal licorice cream, prepared by the University Pharmacology Research Center, Approved dose of gynecologist, use at night with the applicator, The duration of use is 14 days, then 10 days of rest and 14 days of drug re-use.
Category
Treatment - Drugs
2
Description
Receiving 2% estrogen vaginal cream, Approved dose of gynecologist, use at night with the applicator, The duration of use is 14 days, then 10 days of rest and 14 days of drug re-use.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ilam Health Center
Full name of responsible person
Amin karimi
Street address
Khorramshahr Street, Ilam Health Center
City
Ilam
Province
Ilam
Postal code
6931853615
Phone
+98 84 3333 3127
Email
amin.karimy@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Kalvandi gholamreza
Street address
Pajohesh blvd, Banganjab
City
ILAM
Province
Ilam
Postal code
6939177143
Phone
+98 84 3223 5724
Email
kalvandi-gh@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Parisa ahmadizad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tajarian6, chalimar
City
Ilam
Province
Ilam
Postal code
6931156381
Phone
+98 84 3222 7567
Email
p.ahmadizaddd@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Masoume shohani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pajohesh Blvd, Bangangab Ave, Ilam
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
Msh282000@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Parisa ahmadizad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tajarian6, chalimar
City
Ilam
Province
Ilam
Postal code
6931156381
Phone
+98 84 3222 7567
Email
p.ahmadizaddd@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
1-Study protocol 2- Study result
When the data will become available and for how long
After completing the study
To whom data/document is available
1- Faculty members 2- Clinical nurses 3- Medical and nursing students
Under which criteria data/document could be used
Access to data or documentation is possible for the following condition: 1- Use in future study resources 2- Future studies