EVALUATION OF SAFETY, EFFICACY, AND QUALITY OF LIFE OUTCOMES IN PATIENTS WITH ABNORMAL UTERINE BLEEDING TREATED WITH LEVONORGESTREL INTRAUTERINE SYSTEM
Author(s)
Queeni Sharoon Melam, PharmD1, Manoj Kumar Mudigubba, MPH, PharmD, PhD1, Jyothi Suchithra Mekala, MBBS, DGO, DNB2, Nijavalli Nagalakshmi, PharmD1, Jahnavi Konda, PharmD1, Metagiri Suleman, PharmD1.
1Raghavendra Institute of Pharmaceutical Education and Research, Anantapur, India, 2Obstetrics and Gynecology, Rural Development Trust Hospital, Bathalapalli, India.
1Raghavendra Institute of Pharmaceutical Education and Research, Anantapur, India, 2Obstetrics and Gynecology, Rural Development Trust Hospital, Bathalapalli, India.
OBJECTIVES: Evaluation of safety, efficacy, and quality of life in patients with abnormal uterine bleeding undergoing management with the levonorgestrel-releasing intrauterine system (LNG-IUS).
METHODS: This prospective observational study was conducted in the Obstetrics and Gynaecology Department of a rural tertiary-care hospital. Women aged 40-55 years with abnormal uterine bleeding treated with LNG-IUS were included; those with coagulopathies, endocrine disorders, uterine anomalies, submucosal fibroids, cavity-distorting polyps, PID, or undiagnosed genital cancers were excluded. The baseline evaluation included menstrual history, pelvic examination, haemoglobin level, and quality-of-life assessment. LNG-IUS was inserted under aseptic conditions, and participants were followed monthly for six months with PBAC scoring and safety assessments. Data were analysed using SPSS 27 with repeated-measures ANOVA, Friedman test, and Cochran’s Q test (p<0.05).
RESULTS: Fifty women with heavy menstrual bleeding were followed for six months after LNG-IUS insertion. Mean PBAC scores fell from 217.66 to 106.84, and abdominal pain scores from 4.04 to 1.30, both highly significant (p<0.001). The proportion with heavy menstrual bleeding decreased from 100% to 64%. Haemoglobin levels were maintained with a slight but significant improvement (10.006 to 10.112 g/dL; p=0.005). Intermenstrual spotting declined from 46% at baseline to 0% by the 4th month (p<0.001). Quality-of-life scores improved markedly from 35.50 to 51.68 (p<0.001).
CONCLUSIONS: LNG-IUS is a safe, effective, organ-preserving treatment for perimenopausal AUB, significantly reducing bleeding and pain while improving haemoglobin levels and overall quality of life.
METHODS: This prospective observational study was conducted in the Obstetrics and Gynaecology Department of a rural tertiary-care hospital. Women aged 40-55 years with abnormal uterine bleeding treated with LNG-IUS were included; those with coagulopathies, endocrine disorders, uterine anomalies, submucosal fibroids, cavity-distorting polyps, PID, or undiagnosed genital cancers were excluded. The baseline evaluation included menstrual history, pelvic examination, haemoglobin level, and quality-of-life assessment. LNG-IUS was inserted under aseptic conditions, and participants were followed monthly for six months with PBAC scoring and safety assessments. Data were analysed using SPSS 27 with repeated-measures ANOVA, Friedman test, and Cochran’s Q test (p<0.05).
RESULTS: Fifty women with heavy menstrual bleeding were followed for six months after LNG-IUS insertion. Mean PBAC scores fell from 217.66 to 106.84, and abdominal pain scores from 4.04 to 1.30, both highly significant (p<0.001). The proportion with heavy menstrual bleeding decreased from 100% to 64%. Haemoglobin levels were maintained with a slight but significant improvement (10.006 to 10.112 g/dL; p=0.005). Intermenstrual spotting declined from 46% at baseline to 0% by the 4th month (p<0.001). Quality-of-life scores improved markedly from 35.50 to 51.68 (p<0.001).
CONCLUSIONS: LNG-IUS is a safe, effective, organ-preserving treatment for perimenopausal AUB, significantly reducing bleeding and pain while improving haemoglobin levels and overall quality of life.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PCR68
Topic
Patient-Centered Research
Disease
SDC: Reproductive & Sexual Health