Health Condition 1: null- Dysfunctional Uterine Bleeding
Conditions
Interventions
Intervention1: Emily: Levonorgestrel-releasing Intrauterine System (52 mg), delivering up to 20 μg Levonorgestrel per day
Intervention2: Emily: Levonorgestrel-releasing Intrauterine System (52 mg), d
Sponsors
HLL Lifecare Limited
Eligibility
Inclusion criteria
Inclusion criteria: Indian women >30 and 2. Married and having at least one normal living child 3. Must be having a history of excessive menstrual bleeding for a minimum of last 3 cycles (as evidenced by a baseline Pictorial Blood Assessment Chart [PBAC] score1 of 100 or more) 4. Not using any other hormonal method of contraception 5. Willing to use IUS for the treatment of DUB 6. Not contemplating pregnancy during the course of study 7. Must be willing to give written informed consent and comply with the study procedures 8. Expect to continue living in an area accessible to the study center for the duration of the study
Exclusion criteria
Exclusion criteria: . Known or suspected pregnancy 2. Last delivery or abortion within the past 3 months 3. Intermenstrual bleeding 4. Postmenopausal bleeding (bleeding after more than one year from the last menstrual period) 5. Demonstrable pathological cause for DUB including pelvic inflammatory disease and untreated acute cervicitis or vaginitis 6. Congenital abnormality of the uterus 7. Abnormal PAP smear report 8. Presence of diabetes mellitus (subjects with a random blood sugar [RBS] level above 200 mg/dL) 9. Uncontrolled hypertension defined as BP _140/90 mm Hg in a supine position after resting for 15 minutes) 10. History or presence of incapacitating migraine 11. History of cerebrovascular disease and coronary artery disease 12. Known or suspected tumors of liver, kidney, ovary, uterus, cervix and breast 13. History of thrombophlebitis or thromboembolism in the past 14. On any prohibited medication (hepatotoxic drugs, herbal or ayurvedic products) during the past one month 15. On immunosuppressive treatment 16. Known hypersensitivity to micronized progesterone or silicone rubber or any component of this product 17. Thyroid Stimulating Hormone (TSH) levels 7 IU/mL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) To assess the efficacy of Levonorgestrel Intrauterine System (LNG-IUS) (Emily) in terms of the reduction of menstrual blood loss in Indian women with Dysfunctional Uterine Bleeding (DUB) (2) To assess the acceptability rate of LNG-IUS (Emily) Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| (3) To assess subject satisfaction from improvement in the quality of life using EQ-5D-3L Quality Of Life (QOL) Questionnaire (4) To assess the safety of LNG-IUS (Emily) Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactDrGRajmohan
SUT Academy of medical sciences
Outcome results
None listed