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Hormone containing Intra Uterine Device Insertion:A simple method of treatment for heavy menstrual bleeding

Efficacy and acceptability of levnorgestrarel containing intra uterine device (LNG -IUS):A conservative approach to management of abnormal uterine bleeding - LNG -IUS

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/012937
Enrollment
30
Registered
2018-04-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Women those who are having menorrhagia diagnosed as Abnormal uterine Bleeding

Interventions

Intervention1: Levnorgestrel containing Device: It is a T shaped device containing Levnorgestrel. 20mcg per day of drug is released in the uterine cavity Control Intervention1: Nil: Nil

Sponsors

Dr Ruchi Kalra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) All women those who are having menorrhagia diagnosed as AUB 2) Fibroid cases where uterine cavity is not distorted 3) Uterus size less than 12 wks in case of adenomyosis 4) Endometriosis where woman is not desirous of conception 5) Patient medically high risk for surgery with any of the above criteria 6) Patient willing for regular follow up

Exclusion criteria

Exclusion criteria: 1) PID â??Treat PID 1st then if she meets above criteria 2) Patient not willing for regular Follow up 3) Those planning for pregnancy

Design outcomes

Primary

MeasureTime frame
Evaluation of efficacy of LNG IUS in treating menorrhagia by (a)history of change of menstrual cycle pattern with relief of symptoms (b)Heamoglobin levels. Follow up of the cases will be done till two years Timepoint: Time of Insertion, 3 months, 6 months, 1 year,2 year

Secondary

MeasureTime frame
To study Acceptability by giving questionnaire for assessment of quality of lifeTimepoint: 3 months, 6 months, 1 year, 2 year

Countries

India

Contacts

Public ContactRuchi Kalra

Peoples University Bhopal

drruchi.kalra15@gmail.com07554005110

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026