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, when added to a copper-releasing intrauterine contraceptive device, that is needed to reduce menstrual blood loss to a very low level and to treat (essential) menorrhagia successfully.


METHODS
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, releasing 0 (control), 1.5, 3, or 6 microg of 3-keto-desogestrel daily. Menstrual blood loss, hemoglobin, and serum ferritin levels were determined before and during treatment.


RESULTS
All 3-keto-desogestrel-copper intrauterine contraceptive devices reduced 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 ferritin levels rose with all three 3-keto-desogestrel-loaded devices.


CONCLUSIONS
A Multiload Cu250 intrauterine contraceptive device releasing 1.5 microg 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 without menorrhagia. Higher doses have no superior effect.
Janssen
C A
CA
Department of Obstetrics and Gynecology, University Medical Centre Utrecht, Utrecht, The Netherlands.
Scholten
P C
PC
Heintz
A P
AP
D000293:Adolescent; D000328:Adult; D017135:Desogestrel / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D015536:Down-Regulation; D004337:Drug Carriers; D005260:Female; D005293:Ferritins / Q000097:blood; D006801:Humans; D007436:Intrauterine Devices, Medicated; D008595:Menorrhagia / Q000097:blood / Q000188:drug therapy; D008599:Menstruation Disturbances / Q000097:blood / Q000188:drug therapy*; D008875:Middle Aged; D045167:Progesterone Congeners / Q000627:therapeutic use*
D004337:Drug Carriers; D045167:Progesterone Congeners; C044815:etonogestrel; D017135:Desogestrel; D005293:Ferritins