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General information
empty
In the random assignment section, the names of the groups were written in two groups.
In the random assignment section, the names of the groups were written in two groups.
empty
در بخش تخصیص تصادفی نام گروهها دو گروه نوشته شده بود.
در بخش تخصیص تصادفی نام گروهها دو گروه نوشته شده بود.
The randomization method is simple. The random allocation sequence will be determined using the "computer Random generation" computer program. The sealed envelopes encoded and non-transparent (A and B) for the allocation of subjects to intervention (A) and control (B) groups will be used.
The randomization method is simple. The random allocation sequence will be determined using the "computer Random generation" computer program. The sealed envelopes encoded and non-transparent (A، B ، C ، D) for the allocation of subjects to intervention (A، B ، C) and control (D) groups will be used.
The randomization method is simple. The random allocation sequence will be determined using the "computer Random generation" computer program. The sealed envelopes encoded and non-transparent (A and، B ، C ، D) for the allocation of subjects to intervention (A، B ، C) and control (BD) groups will be used.
روش تصادفی سازی ساده می باشد. توالی تخصیص تصادفی با استفاده از برنامه کامپیوتری "Computer Random Generation" تعیین خواهد شد. از پاکت های سربسته کد گذاری شده و غیر شفاف ( A و B) جهت تخصیص واحدهای پژوهش به گروه های مداخله (A) و کنترل(B) استفاده خواهد گردید.
روش تصادفی سازی ساده می باشد. توالی تخصیص تصادفی با استفاده از برنامه کامپیوتری "Computer Random Generation" تعیین خواهد شد. از پاکت های سربسته کد گذاری شده و غیر شفاف (A، B ، C ، D) جهت تخصیص واحدهای پژوهش به گروه های مداخله (A، B ، C ) و کنترل(D) استفاده خواهد گردید.
روش تصادفی سازی ساده می باشد. توالی تخصیص تصادفی با استفاده از برنامه کامپیوتری "Computer Random Generation" تعیین خواهد شد. از پاکت های سربسته کد گذاری شده و غیر شفاف (A و، B ، C ، D) جهت تخصیص واحدهای پژوهش به گروه های مداخله (A، B ، C ) و کنترل(Bکنترل(D) استفاده خواهد گردید.
Protocol summary
Study aim
Evaluation of the effect of sildenafil along with melatonin on the sexual function of patients with polycystic ovary syndrome treated with metformin.
Design
clinical trial with a control group; with parallel groups; Randomized; Designed in 216 patients
Settings and conduct
Eligible patients referred to Shahid Muftah Clinic of Yasouj University of Medical Sciences will be divided into four groups of 54 people and sexual performance will be measured.
Participants/Inclusion and exclusion criteria
Eligibility conditions: patients aged 18 to 45 years; body mass index 19-25; Confirmation of polycystic ovary syndrome based on the Rotterdam criteria.
Conditions for not entering the study: patients who do not want to cooperate; Sildenafil sensitivity ; pregnancy; taking ocp or ovulation stimulation drugs; current use of drugs affecting sexual performance; Previous diagnosis of an organic cause for sexual dysfunction by an experienced physician; Taking vasodilator drugs and drugs that interact with metformin, sildenafil, and melatonin
Intervention groups
Intervention group A: sildenafil (daily 25 mg of sildenafil citrate (Vizarcin)) along with metformin tablets (500 mg orally three times a day); Intervention group B: melatonin (daily 3 mg melatonin tablets (Razak Pharmaceutical Company, Iran) along with metformin tablets (500 mg three times a day orally); intervention group C: melatonin (daily 3 mg melatonin tablets Razak Pharmaceutical Company , Iran) along with sildenafil (25 mg sildenafil citrate (Vizarcin) daily) along with metformin tablets (500 mg orally three times a day); control group: metformin tablets (500 mg orally three times a day)
Main outcome variables
Sexual function
General information
Reason for update
In the random assignment section, the names of the groups were written in two groups.
Acronym
IRCT registration information
IRCT registration number:IRCT20160524028038N13
Registration date:2022-12-09, 1401/09/18
Registration timing:prospective
Last update:2022-12-12, 1401/09/21
Update count:1
Registration date
2022-12-09, 1401/09/18
Registrant information
Name
Fatemeh Bazarganipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3366 6367
Email address
bazarganipour@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-21, 1401/09/30
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of sildenafil along with melatonin on the sexual function of patients with polycystic ovary syndrome treated with metformin.
Public title
The effect of sildenafil and melatonin on sexual function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 45 years
Body mass index 19-25
Confirmation of polycystic ovary syndrome based on the Rotterdam criteria
Exclusion criteria:
Patients who do not want to cooperate.
Sildenafil sensitivity and intolerance to side effects (hot flashes, vision disorders, severe drop in blood pressure and hearing disorders)
pregnancy
Taking ocp or ovulation stimulation drugs
Existence of severe mental conditions since 6 months before the research, which has an adverse effect on the patient's quality of life
Suffering from a severe degree of depression and anxiety according to the depression and anxiety questionnaire based on the Beck depression and anxiety questionnaire
Current use of psychiatric medications
Language or cognitive problems preventing the patient from completing the questionnaire
smoking
Current use of drugs affecting sexual performance
Previous diagnosis of an organic cause for sexual dysfunction by an experienced physician
Taking vasodilator drugs and drugs that interact with metformin, sildenafil, and melatonin
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
216
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple. The random allocation sequence will be determined using the "computer Random generation" computer program. The sealed envelopes encoded and non-transparent (A، B ، C ، D) for the allocation of subjects to intervention (A، B ، C) and control (D) groups will be used.
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 of Yasuj University of Medical Sciences
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, kohgiluyeh and boyer-ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Approval date
2022-10-12, 1401/07/20
Ethics committee reference number
IR.YUMS.REC.1401.116
Health conditions studied
1
Description of health condition studied
polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Sexual function
Timepoint
Before the intervention and three after the intervention
Method of measurement
FSFI sexual function questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Sildenafil (sildenafil citrate (Vizarcin) 25 mg daily) + metformin tablets (500 mg three times a day orally)
Category
Treatment - Drugs
2
Description
Intervention group: melatonin (3 mg of melatonin tablets daily (Razak Pharmaceutical Company, Iran) along with metformin tablets (500 mg orally three times a day)
Category
Treatment - Drugs
3
Description
Intervention group: Melatonin (3 mg melatonin tablets per day, Razak Pharmaceutical Company, Iran) along with sildenafil (25 mg sildenafil citrate (Vizarsin) per day) along with metformin tablets (500 mg orally three times a day)
Category
Treatment - Drugs
4
Description
Control group: metformin tablets (500 mg orally three times a day)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yasuj University of medical sciences, Shahid Mofateh Clinic
Full name of responsible person
Sadaf Abbasi
Street address
Yasuj University of medical sciences, Shahid Mofateh Clinic, Motahari Bulvard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
sadaf.abbasi1365@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Amin Hosseini
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
amin.hosseini@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Sadaf Abbasi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
sadaf.abbasi1365@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sadaf Abbasi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
sadaf.abbasi1365@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sadaf Abbasi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
sadaf.abbasi1365@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available