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IRCT20110606006709N22 IRCT 2021-02-24 Tabriz University of Medical Sciences Comparison of the effect of COCs and vitamin D-COCs on ovulatory dysfunction Bleeding in reproductive age women Comparative of the effect of Combined oral contraceptive pills (COCs) and vitamin D - COCs on Ovulatory dysfunction bleeding (AUB-O) in reproductive age women : A triple blind randomized controlled clinical trial 2021-02-19 anticipated 60 Complete https://irct.ir/trial/52196 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be divided into two groups: COCs group, COCs group - Vitamin D using random blocking method with the size of four and six blocks with 1: 1 allocation ratio. Assignment sequence with the help of the researcher and using the software Random Allocation Software will be specified. To conceal the allocation, closed opaque envelopes will be prepared and numbered according to the number of samples. Envelope preparation and random allocation sequencing will be performed by the non-research person, Blinding description: The drugs and their placebo will be prepared by the pharmaceutical company in a completely similar way in terms of shape, color and smell. The researcher, participants, data analyst, and outcome reviewer are unaware of the type of intervention received. 3 Ovulatory dysfunction bleeding. Intervention 1: Control group: LD capsules (containing 30 micrograms of ethinyl estradiol and 150 micrograms of levonorgestrel), 21 tablets with 9 placebo capsules daily, one for three cycles. Intervention 2: Intervention group: Combination capsules containing vitamin D (1000 units of cholecalciferol) and LD (30 micrograms of ethinyl estradiol and 150 micrograms of levonorgestrel) of 21 and then 9 vitamin D capsules daily, one for three cycles. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is after the completion of the project the decision will be made
public Mahdis Goodarzvand Chegini
Faculty of Nursing and Midwifery ,South Shariati Street
Tabriz Iran (Islamic Republic of) 5415933739 +98 41 4226 3582 mahdis.chegini71@gmail.com Tabriz University of Medical Sciences scientific Mahnaz Shahnazi
Faculty of Nursing and Midwifery, South Shariati Street.
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3477 2699 mshahnazi@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Women 18-45 years old Have at least 2-3 months of history of excessive, long and irregular bleeding (lack of regular cycle 28-35, bleeding more than 7 days or heavy) Have a phone number to follow up. 18 years 45 years Female Pregnancy Any cervical abnormality including cervical cancer, infection, trauma or polyp and uterine causes including: leiomyoma, infection, polyp, endometrial hyperplasia, endometrial neoplasia, cancer or the presence of a foreign body based on the patient's statement and medical records. Having any kind of severe psychological stress such as: separation of parents, death of first-degree family members, etc. in the last 6 months. Having any kind of systemic diseases, such as: thyroid disease (hypothyroidism and hyperthyroidism), adrenal glands, liver, kidney and blood disorders (von Willebrand disease, idiopathic thrombocytopenic purpura, and leukemia) based on the patient's statement and medical records. Daily and regular intake of vitamin D supplements for the past three months. Taking medications that affect the menstrual cycle and bleeding, such as: oral hormonal contraceptives, anticoagulants, serotonin inhibitors, antipsychotics, corticosteroids, hormonal supplements, phenytoin, or herbal supplements such as soy and ginseng. Having premenstrual syndrome. Have any absolute or relative contraindications to the use of combined contraceptive pills, including breast cancer, endometrial cancer, liver disease, deep vein thrombosis, smoking in people 35 years and older, cardiovascular disease, history of stroke, Diabetes, hypertension, migraine, hyperlipidemia, conditions requiring complete immobility, inflammatory bowel disease, major depression, and epilepsy require medication. N93.8 Other specified abnormal uterine and vaginal bleeding Treatment - Drugs Treatment - Drugs Control group: LD capsules (containing 30 micrograms of ethinyl estradiol and 150 micrograms of levonorgestrel), 21 tablets with 9 placebo capsules daily, one for three cycles Intervention group: Combination capsules containing vitamin D (1000 units of cholecalciferol) and LD (30 micrograms of ethinyl estradiol and 150 micrograms of levonorgestrel) of 21 and then 9 vitamin D capsules daily, one for three cycles Menstrual bleeding rate. Timepoint: Before the intervention, one month, two months and three months after the start of the intervention, after the end of the intervention. Method of measurement: Higham Questionnaire. Number of menstrual bleeding days. Timepoint: Before the intervention, one month, two months and three months after the start of the intervention, after the end of the intervention. Method of measurement: Calendar. The duration of the menstrual cycle. Timepoint: Before the intervention, one month, two months and three months after the start of the intervention, after the end of the intervention. Method of measurement: Calendar. Quality of life score. Timepoint: Before the intervention, after the end of the intervention. Method of measurement: SF-36 questionnaire. Side effects. Timepoint: The first, second and third months after the start of the intervention. Method of measurement: Side effects questionnaire. Satisfaction of treatment. Timepoint: after the end of the intervention. Method of measurement: Patient Satisfaction Questionnaire. Tabriz University of Medical Sciences Approved 2021-02-14 Ethics Committee of Tabriz University of Medical Sciences Research department., third floor., central construction number 2., Tabriz University of Medical Sciences., Golgasht Street., Azadi Avenue Tabriz East Azarbaijan Iran (Islamic Republic of)