Comparison of the effect of COCs and vitamin D-COCs on ovulatory dysfunction Bleeding in reproductive age wome

Phase 3

Recruiting

• Conditions: Ovulatory dysfunction bleeding.; Other specified abnormal uterine and vaginal bleeding; N93.8

• Registration Number: IRCT20110606006709N22
• Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.