1. Home
  2. Approved trials
  3. » فارسی

Evaluating the effectiveness of vaginal cream (An Iranian Traditional Medicine product) on subjective symptoms of vulvovaginal atrophy in women with breast cancer

Protocol summary

Study aim
Evaluating the effectiveness of vaginal cream (An Iranian Traditional Medicine product) on subjective symptoms of vulvovaginal atrophy in women with breast cancer referred to Oncology-Radiotherapy Clinic of Shohadaye Tajrish hospital
Design
A clinical trial, before and after, on a group of 50 patients
Settings and conduct
We will evaluate the subjective symptoms of vulvovaginal atrophy (itching, burning, dryness, dyspareunia) at baseline (before intervention), second and fourth weeks of intervention and two and four weeks after the intervention completion, the female sexual function index (sexual desire, sexual arousal, vaginal lubrication, orgasm, sexual satisfaction, sexual pain) were also included at baseline and 4 weeks after initiating the intervention (at intervention completion). Study location: Oncology-Radiotherapy Clinic of Shohadaye Tajrish hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having a patient's consent to participate in the project, Ability to fill out forms and questionnaires alone or with the help of a researcher, Age 18 years or older, Married, Menopause, History of breast cancer, Hormonal treatment history, Having subjective symptoms of vulvovaginal atrophy (itching, burning, dryness, dyspareunia) with a minimal sum score of 3; Exclusion criteria: Having multiple sex partners, Acute psychiatric illness and antidepressant use during the last month, Other cancers at the same time as breast cancer, Incomplete chemotherapy and radiotherapy, Use of lubricant or vaginal moisturizer and other vaginal medications during the last month, Not having a negative Pap smear over the last year
Intervention groups
Vaginal cream (An Iranian Traditional Medicine product) recipients
Main outcome variables
Vulvovaginal atrophy subjective symptoms score; itching score; burning score; dryness score; dyspareunia score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191210045687N1
Registration date: 2020-02-12, 1398/11/23
Registration timing: prospective

Last update: 2020-02-12, 1398/11/23
Update count: 0
Registration date
2020-02-12, 1398/11/23
Registrant information
Name
Maryam Radmanesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
m.radmanesh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-15, 1398/11/26
Expected recruitment end date
2020-05-09, 1399/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of vaginal cream (An Iranian Traditional Medicine product) on subjective symptoms of vulvovaginal atrophy in women with breast cancer
Public title
Evaluating the effectiveness of the traditional vaginal product on vulvovaginal atrophy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a patient's consent to participate in the project Ability to fill out forms and questionnaires alone or with the help of a researcher 18 years or older Married Menopause History of breast cancer Hormonal treatment history Having subjective symptoms of vulvovaginal atrophy (itching, burning, dryness, dyspareunia) with a minimal sum score of 3
Exclusion criteria:
Having multiple sex partners Acute psychiatric illness and antidepressant use during the last month Other cancers at the same time as breast cancer Incomplete chemotherapy and radiotherapy Use of lubricant or vaginal moisturizer and other vaginal medications during the last month Not having a negative Pap smear over the last year
Age
From 18 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
3th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-12-01, 1398/09/10
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.437

Health conditions studied

1

Description of health condition studied
Vulvovaginal atrophy
ICD-10 code
N95.2
ICD-10 code description
Postmenopausal atrophic vaginitis

Primary outcomes

1

Description
Subjective Symptom Score of Vulvovaginal Atrophy Based on Vulvovaginal Subjective Symptom Score Form from 3 to 16
Timepoint
Evaluation of subjective symptoms of vulvovaginal atrophy at baseline (before intervention), 2 and 4 weeks after the intervention beginning, 2 and 4 weeks after the intervention completion
Method of measurement
Vulvovaginal Subjective Symptom Score Form

2

Description
Vulvovaginal Dryness Score Based on Vulvovaginal Subjective Symptom Score Form from 1 to 4
Timepoint
Evaluation of vulvovaginal dryness at baseline (before intervention), 2 and 4 weeks after the intervention beginning, 2 and 4 weeks after the intervention completion
Method of measurement
Vulvovaginal Subjective Symptom Score Form

3

Description
Vulvovaginal Itching Score Based on Vulvovaginal Subjective Symptom Score Form from 1 to 4
Timepoint
Evaluation of vulvovaginal Itching at baseline (before intervention), 2 and 4 weeks after the intervention beginning, 2 and 4 weeks after the intervention completion
Method of measurement
Vulvovaginal Subjective Symptom Score Form

4

Description
Vulvovaginal burning Score Based on Vulvovaginal Subjective Symptom Score Form from 1 to 4
Timepoint
Evaluation of vulvovaginal burning at baseline (before intervention), 2 and 4 weeks after the intervention beginning, 2 and 4 weeks after the intervention completion
Method of measurement
Vulvovaginal Subjective Symptom Score Form

5

Description
Dyspareunia Score Based on Vulvovaginal Subjective Symptom Score Form from 1 to 4
Timepoint
Evaluation of dyspareunia at baseline (before intervention), 2 and 4 weeks after the intervention beginning, 2 and 4 weeks after the intervention completion
Method of measurement
Vulvovaginal Subjective Symptom Score Form

Secondary outcomes

1

Description
Female Sexual Function Index Score
Timepoint
At the beginning of the study (before intervention) and 4 weeks after the intervention (Intervention completion)
Method of measurement
Female Sexual Function Index Questionnaire

2

Description
Sexual desire score
Timepoint
At the beginning of the study (before intervention) and 4 weeks after the intervention (Intervention completion)
Method of measurement
Female Sexual Function Index Questionnaire

3

Description
Sexual arousal score
Timepoint
At the beginning of the study (before intervention) and 4 weeks after the intervention (Intervention completion)
Method of measurement
Female Sexual Function Index Questionnaire

4

Description
Vaginal lubrication score
Timepoint
At the beginning of the study (before intervention) and 4 weeks after the intervention (Intervention completion)
Method of measurement
Female Sexual Function Index Questionnaire

5

Description
Orgasm score
Timepoint
At the beginning of the study (before intervention) and 4 weeks after the intervention (Intervention completion)
Method of measurement
Female Sexual Function Index Questionnaire

6

Description
Sexual satisfaction score
Timepoint
At the beginning of the study (before intervention) and 4 weeks after the intervention (Intervention completion)
Method of measurement
Female Sexual Function Index Questionnaire

7

Description
Sexual pain score
Timepoint
At the beginning of the study (before intervention) and 4 weeks after the intervention (Intervention completion)
Method of measurement
Female Sexual Function Index Questionnaire

8

Description
Satisfaction of treatment
Timepoint
After the Intervention completion
Method of measurement
Asking the patient

Intervention groups

1

Description
Intervention group: Use Vaginal Cream (Traditional Iranian Medicine Product) Contains Chicken Oil and Honey Wax, One applicator every other night for 2 weeks followed by one applicator two nights a week for 2 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Oncology-Radiotherapy Clinic of Shohadaye Tajrish hospital
Full name of responsible person
Maryam Radmanesh
Street address
No. 8, Shams Alley (across from Tavanir), Vali-e- Asr Ave.
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
m.radmanesh@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
5th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9780
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Radmanesh
Position
MD, PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 8, Shams Alley (across from Tavanir), Vali-e-Asr Ave.
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
m.radmanesh@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Radmanesh
Position
MD,PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 8,Shams Alley (across from Tavanir), Vali-e-Asr Ave.
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
m.radmanesh@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Radmanesh
Position
MD, PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. Shams Alley (across from Tavanir), Vali-e-Asr Ave.
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
0098 88773521
Email
m.radmanesh@sbmu.ac.ir

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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Publication of results in the form of a Ph.D. thesis and an ISI paper
When the data will become available and for how long
After Ph.D. thesis defense
To whom data/document is available
Public
Under which criteria data/document could be used
For research reasons
From where data/document is obtainable
Shahid Beheshti University of Medical Sciences
What processes are involved for a request to access data/document
Confirmation of responsible person
Comments
Loading...