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Investigating the effectiveness of dextromethorphan on the sexual activity of women with sexual dysfunction

Protocol summary

Study aim
Determining the effectiveness of dextromethorphan on sexual function in women with sexual dysfunction
Design
A pilot clinical trial, placebo-controlled, cross-over, double-blind, randomized, is prepared on 30 patients for randomization of 30 packets (15 drugs ,15 placebos)Patients are assigned to one of the two groups after opening the envelope, numbered from 1 to 30.
Settings and conduct
30 participants are selected based on DSM-V criteria and FSFI score and are randomly assigned to two groups A and B. During the first four weeks , group A will receive 30 mg of dextromethorphan daily, group B will receive a placebo. After a one-week rest, Group A will then receive the placebo for four weeks, group B will receive the 30 mg of dextromethorphan daily for the same duration. The participants will be evaluated at the beginning of the study , at week 4, and 9. The coding of the medication box is done by a third person who is not involved in the study and is decoded at the end of the study.
Participants/Inclusion and exclusion criteria
women aged 18 to 45 diagnosed with a sexual dysfunction (FSFI questionnaire score < 26.55) having a sexual partner for more than 6 months who does not have a sexual disorder. Exclusion criteria: lack of consent to continue participating in the study. Spouse death or divorce. Pregnancy and breastfeeding during the study. Having diseases or taking medications that interfere with sexual function.
Intervention groups
30 patients were randomly assigned to receive either 30mg dextromethorphan or placebo soft gelatin capsule once daily for 4 weeks. Subsequently, after a 1-week washout, they were crossed over
Main outcome variables
The female sexual function score and its subscales are measured as the primary outcome using the Persian version of the female sexual function index questionnaire before the intervention, 4 and 9 weeks after the intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100119003106N45
Registration date: 2024-03-06, 1402/12/16
Registration timing: prospective

Last update: 2024-03-06, 1402/12/16
Update count: 0
Registration date
2024-03-06, 1402/12/16
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-12-16, 1403/09/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of dextromethorphan on the sexual activity of women with sexual dysfunction
Public title
Investigating the effectiveness of dextromethorphan on the sexual activity of women with sexual dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18-45 years Confirmed diagnosis of sexual dysfunction according to psychiatric diagnosis and FSFI questionnaire score under 26.55 Having a sexual partner for the last 6 months.
Exclusion criteria:
Lack of consent to continue participating in the study. Death of spouse or divorce. Pregnancy and breastfeeding during the study. The presence of severe communication disturbances (such as spousal violence) or other significant stressors that justify sexual problems. Spouse's sexual dysfunction. Menopause (natural or induced by surgery). Addictive disorders. Suffering from neurological and mental diseases such as depression disorders. Taking drugs that interfere with sexual function. Simultaneously suffering from other sexual disorders such as vaginismus, paraphilia and sexual identity disorder. Acute liver disease.
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
30 envelopes are prepared with 15 active and 15 placebo cards and shuffled. patients are allocated the next study numbers (1-30) in sequence after opening the sealed envelopes to either drug or placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients, physician, researcher and data collector (student) do not know about who was receiving the actual drug and who was receiving a placebo. An informed consent form is obtained from the patients before entering the study. The coding of the medication box is done by a third person who is not involved in the study and is decoded at the end of the study.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Tehran medial sciences
Street address
No.99, Yakhchal street, Gholhak, Dr. Shariati
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2023-11-28, 1402/09/07
Ethics committee reference number
IR.IAU.PS.REC.1402.515

Health conditions studied

1

Description of health condition studied
Female sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition

Primary outcomes

1

Description
changes in female sexual function score base on the female sexual function index (FSFI)
Timepoint
before intervention, 4, 9 weeks after intervention.
Method of measurement
Female Sexual Function Index (FSFI).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 30 patients were randomly assigned to receive either 30mg dextromethorphan (Soft gelatin capsule dextromethorphan 15mg by Gelocough brand name producted by Dana company) or placebo soft gelatin capsule once daily for 4 weeks. Subsequently, after a 1-week washout, they were crossed over to the other group during the course of the trial.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Personal office
Full name of responsible person
Dr. Behnam Ohadi
Street address
Unit 1, First Floor, No. 2561, Negin Niayesh Building, Zafar (Vahid Dastgerdi) St, Valiasr St
City
Tehran
Province
Tehran
Postal code
1968655897
Phone
+98 21 8864 5120
Email
Behnamohadi5@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Farshad Hashemian
Street address
No.99, Yakhchal street, Dr. Shariati Avenue Tehran
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Email
hashemian.f@iaups.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
10
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Sara Fakharinia
Position
pharm.D candidate
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No 99, Yasaman Alley, Yakhchal St, Shariati Av
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 21 2264 0051
Email
fakharinia.sara@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Farshad Hashemian
Position
Assistant professor/clinical pharmacist
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No.99, Yakhchal strteet, Dr. Shariati Avenue
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 21 2260 0037
Fax
+98 21 8857 7961
Email
hashemian.f@iaups.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Farshad Hashemian
Position
Assisstani proffesor/clinical pharmasist
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
99 yasaman, Yakhchal St, Shariati Av.
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 9802122606133
Fax
+98 21 8857 7961
Email
hashemian.f@iaups.ac.ir
Web page address

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
All the data potentially can be shared after being unidentifiable.
When the data will become available and for how long
Just after the article's publication
To whom data/document is available
For all investigators.
Under which criteria data/document could be used
No more information
From where data/document is obtainable
Applicants can refer to the Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran Medical Sciences, Islamic Azad University, Dr.Hashemian or contact the researcher by sending email to fakharinia.sara@gmail.com
What processes are involved for a request to access data/document
Applicants can apply for research information by visiting the department or by contacting the e-mail address and telephone number as well as providing information on academic studies and the purpose of requesting the information. Applicants must commit themselves to mention the source. If the request is sent six months after the publication of the research information, there searcher will send the data to the requesting party by email within a week.
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