Protocol summary
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Study aim
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Determination of the effect of concomitant administration of hormonal contraceptives (OCP) with vitamin D3 supplements on sexual dysfunction (MDD) in women with polycystic ovary syndrome.
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Design
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Considering that no study has been done on the subject of the research and the study has a 6 months’ follow-up, there is no possibility of doing a preliminary study prior to the main study. With 95% confidence and 90% test power, the number of samples in both groups equal to 31.08 which means 32 participants in each group, and with a 10% drop rate, 35 people participate in both groups with a total number of 70 participants.
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Settings and conduct
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First, 70 women aged 18-40 years old with PCOS, sexual dysfunction and vitamin D3 deficiency will be divided into two equal groups of experimental group and control group. Each group will receive 50,000 UI vitamin D3 pearl per week for up to 12 weeks. Patients in the intervention group will take contraceptive pills (OCP) for 3 months (21 days each month) along with vitamin D3 pearl, and those who are in the control group will take placebo with the exact same appearance and administration order of contraceptive pills for three months.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria
Age: 18-40 years
Diagnosis of Polycystic Ovary Syndrome
Sexual dysfunction
Absence of chronic diseases
Women with vitamin D3 deficiency
Absence of depression
No infertility based on patient's statements
Using condom as a contraceptive method
Exclusion criteria
People who show side effects due to medication consumption
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Intervention groups
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People who are in the experimental group will receive contraceptives (OCP) for 3 months along with vitamin D3 Pearl.
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Main outcome variables
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Considering that vitamin D3 is likely to be useful in improving female sexual function, this study aims to investigate the synergistic effect of OCP with vitamin D3 pearls in women with PCOS.
General information
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Reason for update
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Due to content modification
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150905023897N3
Registration date:
2019-04-06, 1398/01/17
Registration timing:
registered_while_recruiting
Last update:
2024-06-14, 1403/03/25
Update count:
1
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Registration date
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2019-04-06, 1398/01/17
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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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2019-01-20, 1397/10/30
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Expected recruitment end date
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2019-04-18, 1398/01/29
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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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Assessment of the effect of administration of hormonal contraceptives (OCP) with vitamin D3 supplements on the sexual dysfunction in women with polycystic ovary syndrome: A randomized double-blind placebo-controlled clinical triall
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Public title
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Assessment of the effect of contraceptive pills on the treatment of sexual dysfunction in women with polycystic ovary syndrome.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
) Iranian women age 18- 404 years , 2) PCOS based on Rotterdam criteria (19), 3) women having Vitamin D3 level less than 20 ng/ml (base on the test), 4) women having sex in the last month, and 5) women who used non-hormonal contraceptives three months before the start of the study
Exclusion criteria:
included having the history of side effects (such as headache, vomiting from OCP), chronic diseases, including diabetes mellitus, hypertension, Vascular-Thrombi-Embolism (VTE), and thyroid, having the history for sterility, having no history of depression based on Beck Depression Inventory (BDI) questionnaire, having intention to conceive in near future, no need for OCP treatment, the having no history of Cushing's syndrome, adrenal hyperplasia, and adrenal tumor.
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Age
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From 18 years old to 40 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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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In case of vitamin D3 deficiency (less than 20 ng/ml) (20), all participants were randomly divided into two equal groups (A and B) using a random number table, where each selected number was randomly assigned to a group. became This work was done until the number of people in each group was completed. The researcher had no authority to change the status of the assignments or predict the entry of people into any group. Random concealment was performed by a third party who did not participate in the other phases of the intervention
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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the researcher and the patients will be unaware of how participants are treated and grouped. For this purpose, the OCP and placebo are codified by the scientific expert of the drug manufacturer (Iran Hormone Company). The main researcher treats patients double-blindly according to the codes of drug packets. The code of the drug packet is recorded on the form of individual information, and the researcher who tracks and completes the information form will not be aware of the type of treatment.
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Placebo
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Used
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Assignment
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Other
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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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2018-12-18, 1397/09/27
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Ethics committee reference number
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IR.MODARES.REC.1397.169
Health conditions studied
1
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Description of health condition studied
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Polycystic Ovary Syndrome
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ICD-10 code
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ICD-10 code description
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2
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Description of health condition studied
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Sexual Dysfunction
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Sexual Fanction Score obtained in the Female Sexual Function Index (FSFI) questionnaire
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Timepoint
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At the start of the study and 3 and 6 months from the start of the treatment
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Method of measurement
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Female Sexual Function Index (FSFI) questionnaire
2
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Description
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The level of vitamin D 3 in the blood
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Timepoint
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At the start of the study and 3 and 6 months from the start of the treatment
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Method of measurement
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Biochemical examination of blood
Intervention groups
1
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Description
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LD combined oral contraceptive pills produced by Iran Hormone company are consumed for 3 months, 21 days each month from the second day of the menstrual period, then the medication is not taken for 7 days, and then its consumption will start over again. Pills are taken for up to 3 menstrual periods.
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Category
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Treatment - Drugs
2
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Description
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Taking pills of the same color, shape and size (placebo) with LD, which completely has no effect, produced by Iran Hormone company for 3 months, 21 pills each month from the second day of menstruation, and then the medication is not taken for 7 days. Then its consumption start will start again. Pills are taken for up to 3 menstrual periods.
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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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Tarbiat Modares University
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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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Yes - There is a plan to make this available
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Study Protocol
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No - There is not 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
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Title and more details about the data/document
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Information on the main outcome of the study
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When the data will become available and for how long
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1400
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To whom data/document is available
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Academic researchers
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Under which criteria data/document could be used
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Use for further research in the future
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From where data/document is obtainable
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Email Addressing Responsible for Study
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What processes are involved for a request to access data/document
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Submit a request to study and follow up
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Comments
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