Evaluation of the short-term effect of hops on sexual function in postmenopausal women referred to gynecological clinics affiliated to Kashan University of Medical Sciences in 2020-2021
Design
A clinical trial with the control group, with parallel groups, phase 3 on 60 patients.
Settings and conduct
This clinical trial on postmenopausal married women over 45 years of age who refer to Kashan University of Medical Sciences affiliated gynecological clinics due to menopausal problems
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All married women over the age of 45 who have had amenorrhea for at least a year and are experiencing menopause for the first time
Exclusion criteria:
Patients who are allergic to hops or estradiol, estrogen-dependent cancers
Intervention groups
The groups were treated for two months with vaginal estradiol 0.625 mg for 21 nights and 7 nights rest and the other group was treated with hops vaginal extract.
Main outcome variables
Sexual desire, sexual arousal, vaginal lubrication, orgasm
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210405050859N1
Registration date:2021-07-18, 1400/04/27
Registration timing:registered_while_recruiting
Last update:2021-07-18, 1400/04/27
Update count:0
Registration date
2021-07-18, 1400/04/27
Registrant information
Name
Samira Ferdosi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5550 0111
Email address
ferdosi-s@mail.kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2022-01-05, 1400/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Short -term effect of vaginal Hop (Humuluslupulus L.) on sexual function in women with menopausal symptoms
Public title
The effect of hops on female sexual function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All married women over the age of 45 who have had amenorrhea for at least a year and are experiencing menopause for the first time
Exclusion criteria:
Patients who are allergic to hops or estradiol
Estrogen-dependent cancers
Concomitant use of drugs that interfere with sexual function
Underlying diseases including diabetes
Liver disorders, seizures, and autoimmune diseases
Smoking and alcohol consumption
Age
From 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research
Street address
Medical School-Nurse Boulevard-Qotb Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2021-01-26, 1399/11/07
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1399.206
Health conditions studied
1
Description of health condition studied
Menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Sexual desire
Timepoint
Before intervention and 4 weeks after starting the drug
Method of measurement
brief questionnaire measure of sexual functioning in women
2
Description
Sexual arousal
Timepoint
Before intervention and 4 weeks after starting the drug
Method of measurement
brief questionnaire measure of sexual functioning in women
3
Description
Sexual slippage
Timepoint
Before intervention and 4 weeks after starting the drug
Method of measurement
brief questionnaire measure of sexual functioning in women
4
Description
Orgasem
Timepoint
Before intervention and 4 weeks after starting the drug
Method of measurement
brief questionnaire measure of sexual functioning in women
5
Description
Sexual satisfaction
Timepoint
Before intervention and 4 weeks after starting the drug
Method of measurement
brief questionnaire measure of sexual functioning in women
6
Description
Pain during intercourse
Timepoint
Before intervention and 4 weeks after starting the drug
Method of measurement
Brief questionnaire measure of sexual functioning in women
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vaginal estradiol 0.625 mg for 21 nights and 7 nights rest.
Category
Treatment - Drugs
2
Description
Intervention group: Razak vaginal extract (vaginal gel made in Iran and Barij Essential Oil Company of Kashan) is applied every night for a week and then twice a week for two months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Affiliated gynecological clinics of Kashan University of Medical Sciences
Full name of responsible person
Zahra Vahedpour
Street address
Kashan University of Medical Sciences-Qotb Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
zahravahedpoor@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hossain Motedayen
Street address
Research Assistant-Kashan University of Medical Sciences-Qotb Ravandi Blvd-
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
hmotedayyen@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Zahra Vahedpour
Position
Associated
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Medicine- University of Medical Sciences-Qotb Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
zahravahedpoor@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zahra Vahedpour
Position
Associated
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Medicine- University of Medical Sciences-Qotb Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
zahravahedpoor@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zahra Vahedpour
Position
Associated
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Medicine- University of Medical Sciences-Qotb Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
zahravahedpoor@gmail.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be 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
Part of the data such as information about the main outcome or the like can be shared.
When the data will become available and for how long
2 months after printing the results
To whom data/document is available
Researchers
Under which criteria data/document could be used
No analysis is allowed
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document