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Evaluation the Effect of Fenugreek Vaginal Cream on Vaginal Atrophy in Postmenopausal Women

Protocol summary

Summary
The aim of this study was to evaluate the effects of Fenugreek vaginal cream on tretmeant vaginal atrophy in postmenopausal women. This study is randomized, double-blind. study is carry out at East Ahwaz number one health center. Inclusion criteria: Age between 45 to 65, Amenorrhea at less 12 month or have hormone test with FSH level more than 40 unit, Presenting symptom of vaginal atrophy, Have Sexual activity and single partner، Exclusion criteria: Vaginal infection, Genital Abnormalities, The use of Sex Hormones within the 8 weeks preceding study,smoke and alcohol user، Genital Bleeding of unknown Cause, Use of Phytoestrogens such as Soy, Red clover, Fenugreek, Vitex within the last one Month, They are divided into two groups receiving Fenugreek vaginal cream 5% (n=30 ) and placebo (n=30) for 8 weeks. The symptoms of vaginal atrophy evaluation by a self-assessed 4-point scale of composite score was determined ( none, mild, moderate and severe). Vaginal pH and maturation value measured before and after interventions and compared in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017010331705N2
Registration date: 2017-02-09, 1395/11/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-02-09, 1395/11/21
Registrant information
Name
Fakhriyeh Mazalzadeh
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3443 9419
Email address
mazal.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahwaz JundiShapur University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Effect of Fenugreek Vaginal Cream on Vaginal Atrophy in Postmenopausal Women
Public title
Evaluation the Effect of Fenugreek Vaginal Cream on Vaginal Atrophy in Postmenopausal Women
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Age between 45 to 65; Amenorrhea at less 12 month or have hormone test with FSH level more than 40 unit; Presenting symptom of vaginal atrophy; Have Sexual activity and single partner; Exclusion criteria; Vaginal infection؛ Genital Abnormalities؛ The use of Sex Hormones within the 8 weeks preceding studY; user of smoke and alcohol and etc; Genital Bleeding or spotting of unknown Cause; Use of Phytoestrogens such as Soy; Red clove; Fenugreek; Vitex within the last one Month.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ethical Commettee of Ahwaz Jundishapur University of Medical Science
Street address
Department of Research and Information Technology University of Medical Sciences, Ahwaz Jundishapour, Ground Floor, City University, Ahwaz
City
Ahwaz
Postal code
Approval date
2016-12-03, 1395/09/13
Ethics committee reference number
IR.Ajums.REC.1395.556

Health conditions studied

1

Description of health condition studied
Atrophy Vaginal in post menopausal women
ICD-10 code
N95.2
ICD-10 code description
Postmenopausal Atrophic Vaginitis

Primary outcomes

1

Description
percentage of Maturity vaginal
Timepoint
Before and after eight weeks (end of intervention)
Method of measurement
Vaginal smear

2

Description
Vaginal Atrophy
Timepoint
Before intervention, Two weeks after the intervention, Four weeks after intervention, Eight weeks after intervention
Method of measurement
Kupperman Index Questionnaire

3

Description
Vaginal PH
Timepoint
Before and after eight weeks (end of intervention)
Method of measurement
By PH meter strips

Secondary outcomes

1

Description
Sexual function
Timepoint
Before and after intervention
Method of measurement
Female Sexual Function Index (FSFI) questionnaire

2

Description
Temperament
Timepoint
Before and after intervention
Method of measurement
Temperament questionnaires

3

Description
Dyspareunia
Timepoint
Before intervention, Two weeks after the intervention, Four weeks after intervention, Eight weeks after intervention
Method of measurement
self-assessed 4-point scale of composite score

4

Description
menopausal symptoms
Timepoint
Before intervention, 2, 4, 8 weeks after intervention
Method of measurement
Kupperman Index Questionnaire

5

Description
severity of menopausal symptoms
Timepoint
Before intervention, 2, 4, 8 weeks after intervention
Method of measurement
Menopause Rating Scale (MRS) questionnaire

6

Description
Sexual satisfaction
Timepoint
Before and after intervention
Method of measurement
Larson's sexual satisfaction questioner

Intervention groups

1

Description
Cream Vaginal Fenugrrek 5% one Applicator daily for 8 week
Category
Treatment - Drugs

2

Description
control group (placebo) one applicator daily for 8week
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
East's number one health center in Ahwaz
Full name of responsible person
Fakhriyeh Mazalzadeh
Street address
67 Abasi, St. Zetoon Karmandi, Ahwaz Iran
City
Ahwaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahwaz JundiShapur University of Medical Sciences
Full name of responsible person
SHaref Makhmalzadeh
Street address
Ahwaz Jundishapur University of Medical Sciences, opposite the central building, Vice Chancellor for Research, Ahvaz University of Medical Sciences,
City
Ahwuz
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 JundiShapur 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
Fakhriyeh Mazalzadeh
Position
Student Master of Midwifery
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, College of Nursing and Midwifery,
City
Ahvaz
Postal code
Phone
+98 61 3443 9419
Fax
Email
mazal.f@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Khadegeh Hekmat
Position
Master of Midwifery
Other areas of specialty/work
Street address
Ahwaz Jundishapur University of Medical Sciences, School of Nursing and Midwifery
City
Ahwaz
Postal code
Phone
+98 61 3373 8331
Fax
Email
Hekmat.Kh@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Fakhriyeh Mazalzadeh
Position
Student Master of Midwifery
Other areas of specialty/work
Street address
Ahwaz Jundishapur University of Medical Sciences, School of Nursing and Midwifery
City
Ahwaz
Postal code
6163844113
Phone
+98 61 3443 9419
Fax
Email
Mazal.F@Ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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