Protocol summary
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Study aim
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Evaluation of the effect of sildenafil along with melatonin on the sexual function of patients with polycystic ovary syndrome treated with metformin.
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Design
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clinical trial with a control group; with parallel groups; Randomized; Designed in 216 patients
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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)
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Main outcome variables
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Sexual function
General information
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Reason for update
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In the random assignment section, the names of the groups were written in two groups.
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Acronym
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IRCT registration information
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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
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Registration date
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2022-12-09, 1401/09/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-12-21, 1401/09/30
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Expected recruitment end date
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2023-02-19, 1401/11/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the effect of sildenafil along with melatonin on the sexual function of patients with polycystic ovary syndrome treated with metformin.
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Public title
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The effect of sildenafil and melatonin on sexual function
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 45 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
216
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-10-12, 1401/07/20
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Ethics committee reference number
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IR.YUMS.REC.1401.116
Health conditions studied
1
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Description of health condition studied
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polycystic ovarian syndrome
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ICD-10 code
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E28.2
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ICD-10 code description
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Polycystic ovarian syndrome
Primary outcomes
1
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Description
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Sexual function
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Timepoint
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Before the intervention and three after the intervention
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Method of measurement
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FSFI sexual function questionnaire
Intervention groups
1
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Description
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Intervention group: Sildenafil (sildenafil citrate (Vizarcin) 25 mg daily) + metformin tablets (500 mg three times a day orally)
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Category
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Treatment - Drugs
2
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Description
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Intervention group: melatonin (3 mg of melatonin tablets daily (Razak Pharmaceutical Company, Iran) along with metformin tablets (500 mg orally three times a day)
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Category
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Treatment - Drugs
3
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Description
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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)
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Category
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Treatment - Drugs
4
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Description
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Control group: metformin tablets (500 mg orally three times a day)
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yasouj University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available