Menorrhagia Urological and Genital Diseases Menorrhagia
Conditions
Interventions
Levonorgestrel-releasing intrauterine systems compared with standard medical treatment, based on the Royal College of Obstetricians and Gynaecologists (RCOG) guidelines
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Added as of 30/01/2009: The Shaw Menorrhagia Questionnaire All primary and secondary outcomes will be assessed at baseline, 6 months, 1, 2 and 5 years with a possibility of 10 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Added as of 30/01/2009: 1. SF-36® Health Survey 2. Sexual Activity Questionnaire 3. Euroqol EQ-5D All primary and secondary outcomes will be assessed at baseline, 6 months, 1, 2 and 5 years with a possibility of 10 years. | — |
Countries
England, United Kingdom
Outcome results
None listed