Protocol summary
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Study aim
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Comparison of the effect of licorice vaginal cream and estrogen vaginal cream on the sexual function of postmenopausal women
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Design
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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.
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Settings and conduct
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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).
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Study has two intervention groups, each with 41 members.
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Main outcome variables
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Sexual function
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200608047695N1
Registration date:
2022-01-20, 1400/10/30
Registration timing:
retrospective
Last update:
2022-04-02, 1401/01/13
Update count:
2
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Registration date
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2022-01-20, 1400/10/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-07-20, 1399/04/30
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Expected recruitment end date
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2020-11-18, 1399/08/28
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the effect of licorice vaginal cream and estrogen vaginal cream on the sexual function of postmenopausal women
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Public title
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Comparison of the effect of licorice vaginal cream and estrogen vaginal cream on the sexual function of postmenopausal women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Female
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
82
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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)
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-06-22, 1399/04/02
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Ethics committee reference number
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IR.MEDILAM.REC.1399.118
Health conditions studied
1
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Description of health condition studied
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Sexual function of postmenopausal women
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ICD-10 code
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F52
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ICD-10 code description
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Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
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Description
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Sexual function
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Timepoint
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During the study (first day of referral, 30 days after the start of the intervention, 60 days after the start of the intervention)
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Method of measurement
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Female Sexual function Index Questionnaire
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ilam University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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1-Study protocol 2- Study result
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When the data will become available and for how long
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After completing the study
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To whom data/document is available
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1- Faculty members 2- Clinical nurses 3- Medical and nursing students
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Under which criteria data/document could be used
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Access to data or documentation is possible for the following condition: 1- Use in future study resources 2- Future studies
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From where data/document is obtainable
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Please contact parisa ahmadizad
Ahmadizad gmail:
P.ahmadizaddd@gmail.com
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What processes are involved for a request to access data/document
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After sending the email to parisa ahmadizad, the email will be answered as soon as possible
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Comments
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