Ovulatory dysfunction bleeding. Other specified abnormal uterine and vaginal bleeding
Conditions
Interventions
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. Interve
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahdis Goodarzvand Chegini
Tabriz University of Medical Sciences
Outcome results
None listed