A clinical study to evaluate the efficacy and safety of Levonorgestrel Intrauterine System (Emily) in Indian womenwith Dysfunctional Uterine Bleeding

Phase 4

• Conditions: Health Condition 1: null- Dysfunctional Uterine Bleeding

• Registration Number: CTRI/2012/07/002843
• Lead Sponsor: HLL Lifecare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 75

Inclusion Criteria

Indian women >30 and <50 years of age suffering from DUB

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

. 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 <0.4 IU/mL and >7 IU/mL

Study & Design

• Study Type: Interventional
• Study Design: Not specified