Evaluation and comparison between diltiazem gel 2% and lubricant gel in improving sexual function in women with sexual dysfunction
Design
Parallel clinical trial
Settings and conduct
Intervention groups include women referred to the psychosocial clinic of Taleghani Hospital who have sexual dysfunction and difficulty having sex with their partner. One group is given a lubricant gel and the other group is given diltiazem gel 2%, and at the beginning of the study and at the end of the fifth week, the change in women's satisfaction is measured with the FSFI criteria.
Participants/Inclusion and exclusion criteria
Patients' satisfaction to participate in the study؛ having sex for at least one year؛ sexual dysfunction and dissatisfaction with sex for at least 6 months
Intervention groups
This study is done in two groups. Patients are non-randomly divided into two groups and one group is given diltiazem gel 2% and the other group is given lubricant gel. This study will be done during 5 weeks, which FSFI will be evaluated at the beginning of the study and at the end of the fifth week.
Main outcome variables
Improve quality of life, increase sexual satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100127003210N21
Registration date:2021-04-04, 1400/01/15
Registration timing:prospective
Last update:2021-04-04, 1400/01/15
Update count:0
Registration date
2021-04-04, 1400/01/15
Registrant information
Name
Maria Tavakoli Ardakani
Name of organization / entity
Faculty of pharmacy, Shaid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
mariatavakoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-13, 1400/01/24
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison between Diltiazem gel 2% and lubricating gel effects on female with sexual dysfunction refer to psychosexual clinic
Public title
Evaluation and comparison between Diltiazem gel 2% and lubricating gel effects on female with sexual dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having sex with a partner for at least one year
Having sexual dysfunction (FSD) for at least 6 months
Patients' Satisfaction to participate in this study
Exclusion criteria:
Unwillingness of patients to continue to participate in the study
History of allergic reactions to the drug
Not taking the drug to treat vaginal atrophy in menopausal women
No pregnancy and lactation
Not recommended in patients with a history of low blood pressure, heart attack and pulmonary embolism
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Individual Randomization with the Card in Two Groups A and B, in this Way a Number of Cards are selected as the first Intervention Group and the same Number in the second Intervention Group, then by merging the Cards together one Card is drawn and its Allocation is recorded and the Card is returned to the other Cards after it has been removed. The Cards are then re-merged and another Card is withdrawn. The Process continues until a Random Sequence Sample Size is reached.
Blinding (investigator's opinion)
Not 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 Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti School of Pharmacy, Hashemi Rafsanjani Highway ,Valiasr St.
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2020-02-22, 1398/12/03
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.317
Health conditions studied
1
Description of health condition studied
Lack or loss of sexual desire
ICD-10 code
F52.0
ICD-10 code description
Hypoactive sexual desire disorder
Primary outcomes
1
Description
Improving sexual performance and satisfaction in women by measuring the increase of FSFI score
Timepoint
At the beginning of the study, the first week, the second week, the third week, the fourth week, the fifth week
Method of measurement
FSFI
Secondary outcomes
1
Description
Improving the quality and satisfaction of sexual intercourse in women
Timepoint
The beginning of the study and the end of the study
Method of measurement
Female Sexual Function Index (FSFI) questionnaire
Intervention groups
1
Description
Intervention group:In people with a history of sexual dysfunction, the effect of diltiazem topical gel 2% on improving sexual function is investigated.Thus, before starting the study and also after using diltiazem gel 2% for 5 times in a period of 5 weeks, the FSFI questionnaire should be filled in by the person participating in the study and the score changes in this intervention are measured.This gel is used externally in the outer part of the vagina. Also, for better effect, it should be used one hour before intercourse.
Category
Other
2
Description
Control group: In this study, lubricant gel is used to compare the effect of diltiazem gel 2% with placebo. The duration of the study period in this group is 5 weeks and the number of uses is 5 times. Before and at the end of the study, the FSFI questionnaire should be completed by individuals.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Helma Khademi Estahbanati
Street address
Taleghani Hospital، Arabi st.، Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 3704 8887
Email
Helmakhademi@gmail.com
Web page address
https://taleghani.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Nima Naderi
Street address
Shahid Beheshti School of Pharmacy, Hashemi Rafsanjani Highway ,Valiasr St.
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Email
Mpajouhesh@sbmu.ac.ir
Web page address
http://www.pharmacy.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
Helma Khademi Estahbanati
Position
Student of Pharmacy
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Beheshti School of Pharmacy, Hashemi Rafsanjani Highway ,Valiasr St.
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Email
Helmakhademi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maria Tavakoli Ardakani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Beheshti School of Pharmacy, Hashemi Rafsanjani Highway , Valiasr St.
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Email
mariatavakoli@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Helma Khademi Estahbanati
Position
Student of Pharmacy
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Beheshti School of Pharmacy, Hashemi Rafsanjani Highway ,Valiasr St.
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Email
Helmakhademi@gmail.com
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