Objective: comparison the effect of Glycyrrhiza glabra and placebo vaginal creams on treatment of vaginal atrophy in postmenopausal women
Design: double blind randomized clinical trial
Randomization: Subjects will allocate to two equal groups of inhalation and intravenous fentanyl according to table of random numbers.
Participants including major eligibility criteria:
this study will conduct on 70 postmenopausal women refer to Izeh Health Centers. Main inclusion criteria include having sexual activity and single partner; passing at least 12 months of amenorrhea; presence of vaginal atrophy symptoms; normal blood pressure and main exclusion criteria include genital abnormalities; breast diseases with unknown reason; vaginal infection needing treatment; genital bleeding or spotting with unknown reason; hormone therapy or using sex hormones within the 2 months before the study and using of phytoestrogens such as soy, red clover, fenugreek, and vitex within the last one month.
Main outcome: vaginal atrophy
Intervention: Subjects in intervention group will receive one time in each night Glycyrrhiza glabra vaginal cream 2% using an applicator for 8 weeks. Subjects in control group will receive one time in each night placebo vaginal cream using an applicator for 8 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017010331739N1
Registration date:2017-01-27, 1395/11/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-27, 1395/11/08
Registrant information
Name
Mastaneh Sadeghi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8331
Email address
sadeghi.ma@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahwaz Judishapur University of Medical Sciences
Expected recruitment start date
2017-01-09, 1395/10/20
Expected recruitment end date
2017-04-09, 1396/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Glycyrrhiza glabra and placebo vaginal creams on treatment of vaginal atrophy in postmenopausal women
Public title
The effect of Glycyrrhiza glabra vaginal cream on treatment of vaginal atrophy of postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women with sexual activity and single partner; passing at least 12 months of amenorrhea; presence of vaginal atrophy symptoms; normal blood pressure.
Exclusion criteria: Genital abnormalities; breast diseases with unknown reason; liver cholestatic disorders; renal failure; vaginal infection needing treatment; genital bleeding or spotting with unknown reason; hormone therapy or using sex hormones within the 2 months before the study; using of phytoestrogens such as soy, red clover, fenugreek, and vitex within the last one month; body mass index more than 30 kilogram per cubic meter.
.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khuzestan
City
Ahvaz
Postal code
6135715749
Approval date
2016-12-03, 1395/09/13
Ethics committee reference number
555IR.AJUMS.REC.1395
Health conditions studied
1
Description of health condition studied
Vaginal atrophy
ICD-10 code
N95.2
ICD-10 code description
Postmenopausal Atrophic Vaginitis
Primary outcomes
1
Description
Vaginal acidity
Timepoint
Before and after intervention
Method of measurement
By PH strip
2
Description
subjectiv symptoms of vaginal atrophy
Timepoint
Before intervention and two, four and eight weeks after the intervention
Method of measurement
Kupperman index questionnaire
3
Description
Dyspareunia
Timepoint
Before intervention and two, four and eight weeks after the intervention
Method of measurement
Dyspareunia self-administered scale
4
Description
Vaginal dryness
Timepoint
Before intervention and two, four and eight weeks after the intervention
Method of measurement
Vaginal dryness self-administer scale
5
Description
Percent of vaginal cells maturation
Timepoint
Before and after intervention
Method of measurement
Vaginal smear
Secondary outcomes
1
Description
Sexual function
Timepoint
Before and after intervention
Method of measurement
Female sexual function index questionnaire
2
Description
Sexual satisfaction
Timepoint
Before and after intervention
Method of measurement
Larson's sexual satisfaction questionnaire
Intervention groups
1
Description
Subjects in intervention group will receive one time in each night Glycyrrhiza glabra vaginal cream 2% using an applicator for 8 weeks.
Category
Treatment - Drugs
2
Description
Subjects in control group will receive one time in each night placebo vaginal cream using an applicator for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Izeh Health Center number 1
Full name of responsible person
Mastaneh Sadeghi
Street address
Next to Baharan park, Izeh, Khuzestan
City
Izeh
2
Recruitment center
Name of recruitment center
Izeh Health Center number 2
Full name of responsible person
Mastaneh Sadeghi
Street address
Emam Khomeini squere, Izeh, Khuzestan
City
Izeh
3
Recruitment center
Name of recruitment center
Izeh Health Center number 3
Full name of responsible person
Mastaneh Sadeghi
Street address
Next to Behvarzi academy, Behvarzi street, Izeh, Khuzestan
City
Izeh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahwaz Judishapur University of Medical Sciences
Full name of responsible person
Behzad Sharif Makhmal Zadeh
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khuzestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahwaz Judishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
ahra Abbaspoor
Position
Ph.D in Reproductive Health
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khuzestan
City
Ahvaz
Postal code
1579461357
Phone
+98 61 3373 8331
Fax
Email
Abbaspoor-z762@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Zahra Abbaspoor
Position
Ph.D in Reproductive Health
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khuzestan
City
Ahvaz
Postal code
6135715749
Phone
+98 61 3373 8331
Fax
Email
Abbaspoor-z762@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mastaneh Sadeghi
Position
MSc of midwifery
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khuzestan
City
Ahvaz
Postal code
Phone
00
Fax
Email
sadeghi.ma@ajums.ac.ir; sadeghi33708@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)