Objective: To compare the effect of conjugated Estrogens and flaxseed vaginal cream in the treatment vaginal atrophy and sexual satisfaction in postmenopausal women
Design
Purchase of Flaxseed, extraction, ointment and sampling within 7 months, vaginal application by the patient, vaginal atrophy test and statistical analysis
Settings and conduct
The present study is a randomized, triple blind (research unit, researcher, statistic analyst)، clinical trial of two groups. Selection of research units in an accessible and randomized manner in two groups of intervention and control in 60 postmenopausal women. the examination of women in gynecologic clinic of Ghaem Hospital is carried out by the researcher. In the intervention group, the vaginal cream of flaxseed and in the control group. The intervention is 8 weeks, which is received in the first two weeks of each night and then twice a week until the end of the study period. Assessment of atrophy and sexual satisfaction Overall, prior to the study, 4 and 8 weeks after the start of the study wich evaluated by atrophy criteria and Larsson questionnaire are considered. Follow-up on drug use is conducted on a weekly basis at 2 and 6 weeks.
Participants/Inclusion and exclusion criteria
Having amenorrhea for at least 12 months or 6 months with normal FSH more than 40, normal pap smears over the past 3 years and verifying the atrophy PH and degree of maturation of the patient's vaginal cells. Exit criteria include abnormal vaginal bleeding, allergy to Estrogen and Flaxseed
.
Intervention groups
In the intervention group, Flaxseed vaginal cream and in the control group the conjugated Estrogen vaginal
Main outcome variables
Treatment method (Vaginal cream conjugated estrogen, flax seed vaginal cream). Atrophy treatment success rate at 4 and 8 weeks after starting treatment Sexual satisfaction 4 and 8 weeks after starting treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181027041473N1
Registration date:2019-01-09, 1397/10/19
Registration timing:registered_while_recruiting
Last update:2019-01-09, 1397/10/19
Update count:0
Registration date
2019-01-09, 1397/10/19
Registrant information
Name
fahimeh shakeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3872 5264
Email address
shakerif961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison the effect of flaxseed and Conjugated Estrogen vaginal cream in vaginal atrophy and sexual satisfaction of postmenopausal women.
Public title
The comparison the effect of flaxseed and Conjugated Estrogen vaginal cream in vaginal atrophy and sexual satisfaction of postmenopausal women.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a willingness to participated in the study
Married and have sexual activity
age range of 40-65 years
Have literacy to read and write
Amenorrhoea has been followed for at least 12 months or 6 months amenorrhoea with FSH> 40.
Have normal Pap smear in the past 3 years
Clinic diagnosis of vaginal atrophy through a set of criteria including: score 65 or more (based on the VAS visual criteria) of the scale of the most vaginal annoyance symptoms (MBS) and having at least 2 signs of the descriptive evaluation table of vaginal mucus, PH> 5 and VMV≤55 (vaginal maturation grade).
Exclusion criteria:
Abnormal bleeding vaginal (pink to brown spotting or clear bleeding).
have chronic illness such as diabetes, arthritis, cardiovascular disease, active liver disease or gallbladder disease.
having vaginal infection
allergy to estrogen or flax seed compounds
don't suffering of endometrial cancer or breast cancer
Endometrial cancer or breast cancer known or suspected .
Consumer Products hormonal vaginal or transdermal than 4 weeks prior to the study and use of oral estrogen, uterine progesterone 8 weeks before the study and use of implants progesterone and estrogen injections for 3 months and pellets of estrogen and progesterone injections 6 months prior to the study to be
Age
From 40 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by using spss software is done.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In comparison, the control and intervention groups of their vaginal cream flaxseed and estrogen were apparently identical, therefore, the sample case and evaluators, analysts and sample allocators are blind to the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Quraishi Building, university street, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
91735951
Approval date
2018-10-21, 1397/07/29
Ethics committee reference number
IR.MUMS.NURE.REC.1397.051
Health conditions studied
1
Description of health condition studied
atrophy and sexual satisfaction
ICD-10 code
N95.2
ICD-10 code description
Postmenopausal atrophic vaginitis
Primary outcomes
1
Description
atrophy and sexual satisfaction treatment
Timepoint
Performing the intervention then measuring vaginal atrophy and sexual satisfaction in the fourth and eighth weeks.
Method of measurement
Using vaginal maturation index of more than 55 and a vaginal pH of more than 5 and gaining a score of 65 or more from the scale of the most vaginal annoying symptoms and having at least two signs of the symptoms of a descriptive evaluation table of vaginal mucus.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: use conjugated estrogen vaginal cream for 8 weeks, so that the first two weeks every night, then twice a week until the end of the study period
Category
Treatment - Drugs
2
Description
Intervention group: Use flaxseed vaginal cream for 8 weeks so that the first two weeks every night once, then twice a week until the end of the study period
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital Women's Clinic
Full name of responsible person
Dr. Nafiseh Saghafi
Street address
Ghaem Hospital, Shariati squire
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
SaghafiN@mums.ac.ir
2
Recruitment center
Name of recruitment center
Um Al-Banin Hospital Women's Clinic
Full name of responsible person
Dr Fatemeh Tara
Street address
Omolbanin Women's Hospital, Ayatolah Bahjat street 16, Zarineh crossroad
City
Mashhad
Province
Razavi Khorasan
Postal code
0702409278
Phone
+98 51 3223 1061
Email
TaraF@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Mashhad university of medical science, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
TafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fahimeh shakeri
Position
MSc Student Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
faculty of Nursing and Midwifery, Ebnesina Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Shakerif961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Golmakani
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Ebnesina Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
GolmakaniN@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fahimeh Shakeri
Position
MSc student midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
faculty of Nursing and Midwifery, Ebnesina Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 917 138 7781
Email
Shakerif961@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available