Effectiveness and Cost-effectiveness of Levonorgestrel containing Intrauterine system in Primary care against Standard treatment for menorrhagia

Not Applicable

Completed

• Conditions: Menorrhagia; Urological and Genital Diseases

• Registration Number: ISRCTN86566246
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23301731 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26507206 results 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36376071/ (added 15/11/2022) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37924269/ 10-year observational follow-up study (added 06/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-06-11
• Study Completion: 2014-12-31
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 571

Inclusion Criteria

Women between the ages of 25-50 presenting to General Practitioners with menorrhagia, who are not intending to become pregnant in the next 5 years

Exclusion Criteria

1. Taking HRT
2. Patients with any contraindications to an IUS, with or without Levonorgestrel
3. Patients with contraindications to medical therapy
4. Women with abdominally palpable enlarged fibroid uteri (10-12 Weeks size)
5. Women to whom the contraceptive effect of LNG-IUS would be unacceptable.
6. Women with symptoms suggestive of other pathology (irregular bleeding, intermenstrual bleeding, postcoital bleeding)
7. Women with risk factors for endometrial cancer (tamoxifen treatment, unopposed ostrogen treatments)

Study & Design

• Study Type: Interventional
• Study Design: Not specified