None listed
Conditions
Brief summary
We planned to evaluate and compare the effectiveness of norethisterone, tranexamic acid and Levonorgestrel Releasing Intaruterine System in regular heavy menstrual bleeding in reproductive age women. Mean PBAC scores of two periods > or equal to 100 was accepted as 80 mL blood loss and defined as menorrhagia. 66 patients with menorrhagia without organic patologies were enrolled into the study. Patients are divided into three treatment arms sequentially; oral norethisterone, oral tranexamic acid and Levonorgestrel releasing intrauterine system. During 6 months of therapy PBAC scores were recorded by the patients and decrease in PBAC scores at 1st, 3rd and 6th month as well as hemoglobin, hematocrit, serum iron and ferritin levels was measured. Quality of life assessment forms in World Health Organization Quality of Life Short Form, Turkish version which was translated from the original English version, were filled up before and at the end of the study.
Interventions
We planned to divide the study group into three groups:
Arm 1: Oral norethisterone in 15mg/day (3x5 mg) dose for 10 days between 14th and 23th day of the menstrual cycle; the treatment will be given for 6 menstrual cycles
Arm 2: Oral tranexamic acid 4 mg/day (4x1 mg) for the first four days of the menstrual cycle; the treatment will be given for 6 menstrual cycles
Arm 3: Levonorgestrel releasing intrauterine system which releases 20 microgram levonorgestrel /day, will be applied during the 4-5th
We planned to divide the study group into three groups: Arm 1: Oral norethisterone in 15mg/day (3x5 mg) dose for 10 days between 14th and 23th day of the menstrual cycle; the treatment will be given for 6 menstrual cycles Arm 2: Oral tranexamic acid 4 mg/day (4x1 mg) for the first four days of the menstrual cycle; the treatment will be given for 6 menstrual cycles Arm 3: Levonorgestrel releasing intrauterine system which releases 20 microgram levonorgestrel /day, will be applied during the 4-5th day of the menstrual cycle by the physician. The system remains in place for at least 6 months, if the patient is satisfied with the system, it will go on for 5 years.
Sponsors
Mine Kiseli
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
20 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Regularly menstruating patients in the reproductive period, other than adolescents Patients with mean PBAC scores of two menstrual periods greater than 100 Premenopausal women Patients with benign endometrial biopsy Patients who were willing to participate in the study Patients with fibroids smaller than 2 cm, not distorting the endometrial cavity
Exclusion criteria
Malign Cervical cytology Contraindications to current therapies Systemic diseases like hypertension, diabetes, thyroid disease or coronary artery disease Women having used steroid hormone or anticoagulants during last three months or hormonal contraceptive injection during last year
Outcome results
None listed