The effect of low-dose 3-keto-desogestrel added to a copper-releasing intrauterine contraceptive device on menstrual blood loss: A double-blind, dose-finding, placebo-controlled study

OBJECTIVE: We sought to establish the lowest dose of 3-keto-desogestrel, wh en added to a copper-releasing intrauterine contraceptive device, that is n eeded to reduce menstrual blood loss to a very low level and to treat (esse ntial) menorrhagia successfully. STUDY DESIGN: A double-blind group comparative study was designed in which 203 healthy women with or without menorrhagia were enrolled and randomized to four different Multiload Cu250 intrauterine contraceptive devices. relea sing 0 (control), 1.5, 3, or 6 mu g of 3-keto-desogestrel daily. Menstrual blood loss, hemoglobin, and serum ferritin levels were determined before an d during treatment. RESULTS: All 3-keto-desogestrel-copper intrauterine contraceptive devices r educed menstrual blood loss significantly, causing a reduction of up to 30 to 40 mL after 12 months of use. All women with essential menorrhagia were considered to have been successfully treated after 6 months of use. Serum f erritin levels rose with all three 3-keto-desogestrel-loaded devices. CONCLUSION: A Multiload Cu250 intrauterine contraceptive device releasing 1 .5 mu g of 3-keto-desogestrel daily is able to reduce menstrual blood loss to a very low level and to replete body iron stores in women with or withou t menorrhagia. Higher doses have no superior effect.