Menorrhagia
Conditions
Interventions
Hormonal IUDs: levonorgestrel intrauterine systems (52 mg versus 19.5 mg)
Group Mirena (52 mg): 73 women with menorrhagia will use Mirena and will be accompanied by 1 year.
Group Kyleena (19,5 mg): 73
7596
Sponsors
CAISM - Centro de Atenção Integral à Saúde da Mulher
CEMICAMP
Eligibility
Sex/Gender
Female
Age
18 Years to 48 Years
Inclusion criteria
Inclusion criteria: Women with age between 18 years (complete) - 48 years (incomplete); heavy menstrual bleeding (menorrhagia).
Exclusion criteria
Exclusion criteria: Pregnancy; illicit drugs; anticoagulation therapy; recent deep venous thrombosis; coagulopathy; cancer; pelvic inflammatory disease; uterine malformation; polyp or intrauterine fibroid; uterine bleeding of unknown origin; refusal to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Considering the margin of 20%, it is thought that the levonorgestrel intrauterine system of 19.5 mg would be similar to the system of 52 mg on the heavy menstrual bleeding control. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of bleeding pattern between Mirena and Kyleena users by PBAC each 3-month period, after the insertion of IUD.;Comparison of endometrial lining between Mirena and Kyleena users by US scan at baseline and each 3-month period, after the insertion of IUD. ;Comparison of baseline and 12-month hemoglobin levels between Mirena and Kyleena users.;Comparison of baseline and 12-month hematocrit levels between Mirena and Kyleena users.;Comparison of baseline and 12-month serum iron levels between Mirena and Kyleena users.;Comparison of baseline and 12-month ferritin levels between Mirena and Kyleena users. | — |
Countries
Brazil
Contacts
Public ContactMarco Viscola
Outcome results
None listed