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IRCT20150905023897N3 IRCT 2019-04-06 Tarbiat Modares University Assessment of the effect of contraceptive pills on the treatment of sexual dysfunction in women with polycystic ovary syndrome. 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 2019-01-20 anticipated 70 Complete https://irct.ir/trial/36913 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Condition 1: Polycystic Ovary Syndrome. Condition 2: Sexual Dysfunction. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Information on the main outcome of the study When: 1400 To whom: Academic researchers Conditions: Use for further research in the future Where to obtain: Email Addressing Responsible for Study How to obtain: Submit a request to study and follow up Comments:
public D Shahideh Jahanian Sadatmahale
Tarbiat Modares University., Bridge Nasr., Jalale Ale Ahmad Ave
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 4826 shahideh.jahanian@modares.ac.ir Tarbiat Modares University scientific D., Shahideh Jahanian Sadatmahale
Tarbiat Modares University., Bridge Nasr., Jalale Ale Ahmad Ave.,
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 4826 shahideh.jahanian@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) ) 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 18 years 40 years Female 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. Treatment - Drugs Treatment - Drugs 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. 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. Sexual Fanction Score obtained in the Female Sexual Function Index (FSFI) questionnaire. Timepoint: At the start of the study and 3 and 6 months from the start of the treatment. Method of measurement: Female Sexual Function Index (FSFI) questionnaire. The level of vitamin D 3 in the blood. Timepoint: At the start of the study and 3 and 6 months from the start of the treatment. Method of measurement: Biochemical examination of blood. Tarbiat Modares University Approved 2018-12-18 Ethics committee of Tarbiat Modares University of Medical Sciences Tarbiat Modares University., Bridge Nasr., Jalale Ale Ahmad Ave Tehran Tehran Iran (Islamic Republic of)