Comparison of therapeutic efficacy of two different medical treatments and hormone releasing intrauterine device in treatment of heavy uterine bleeding
Phase 4
Completed
- Conditions
- Heavy menstrual bleeding defined by PBAC scoresReproductive Health and Childbirth - Menstruation and menopause
- Registration Number
- ACTRN12612001055897
- Lead Sponsor
- Mine Kiseli
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 66
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decrease in menstrual blood loss measured as PBAC scores described by Higham.[Patients with PBAC scores>100 were included. At 1st, 3rd and 6th month PBAC scores were measured]
- Secondary Outcome Measures
Name Time Method Hemoglobin, hematocrit levels[Basal, at 3rd and 6th months of treatment];Ferritin, serum iron and iron binding capacity[Basal, at 3rd and 6th months of treatment];Quality of Life evaluation by the World Health Organization Quality of Life-Short Form[Before the study, at the end of 6 months of treatment]