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

American Journal of Obstetrics and Gynecology

Volumn 182, Issue 3, 2000, Pages 575-581

  Janssen, Catharina A H ^a   Scholten, Piet C ^b   Heintz, A Peter M ^b  

^a UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^b NONE

Author keywords

Body iron stores in women; Hormone releasing intrauterine contraceptive device; Low dose 3 keto desogestrel; Menorrhagia

Indexed keywords

COPPER INTRAUTERINE DEVICE; ETONOGESTREL; FERRITIN;

ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFECT; FEMALE; FERRITIN BLOOD LEVEL; HUMAN; INTRAUTERINE CONTRACEPTIVE DEVICE; MAJOR CLINICAL STUDY; MENORRHAGIA; MENSTRUATION DISORDER; PRIORITY JOURNAL;

EID: 0034072807     PISSN: 00029378     EISSN: None     Source Type: Journal    
DOI: 10.1067/mob.2000.104805     Document Type: Article

References (27)

1. 1. Hallberg L, Högdahl A, Nilsson L, Rybo G. Menstrual blood loss - a population study. Acta Obstet Gynecol Scand 1966; 45:320-51.
2. 2. Scholten PC. The levonorgestrel IUD - performance and impact on menstruation [thesis]. Utrecht (The Netherlands): OMI University Press; 1989.
3. 3. Lähteenmäki P, Haukkamaa M, Puolakka J, Riikonen U, Sainio S, Suvisaari J, et al. Open randomised study of the use of levonorgestrel releasing intrauterine system as alternative to hysterectomy. BMJ 1998;316:1122-6.
4. 4. Janssen CAH. Menorrhagia and the 3-keto-desogestrel/copper medicated intrauterine device [thesis]. Utrecht (The Netherlands): Elinkwijk BV; 1997.
5. 5. Reinprayoon D, Koetsawang S et al. Microdose intrauterine levonorgestrel for contraception. World Health Organization. Special Programme of Research. Contraception 1987;35:363-79.
6. 6. Diaz S, Croxatto HB, Pavez M, Quinteros E, Carrillo D, Simonetti L, et al. Ectopic pregnancies associated with low dose progestagen-releasing IUDs. Contraception 1980;22:259-69.
7. 7. van Kets HE, Thiery M, van der Pas H, Delbeke L, van Os WAA, Tauber PF, et al. Interim insertion of the ML Cu 250 intrauterine contraceptive device. Contracept Deliv Syst 1980;1:149-54.
8. 8. Kloosterboer HJ, Vonk Noordegraaf CA. Turpijn EW. Selectivity in progesterone and androgen receptor binding of progestagens used in oral contraceptives. Contraception 1988;38:325-32.
9. 9. Sam AP. Controlled release contraceptive devices: a status report. J Controlled Release 1992;22:35-46.
10. 10. Hallberg L, Nilsson L. Determination of menstrual blood loss. Scand J Clin Lab Invest 1964;16:244-8.
11. 11. Newton J, Barnard G, Collins W. A rapid method for measuring menstrual blood loss using automatic extraction. Contraception 1977;16:269-82.
12. 12. van Eijkeren MA, Scholten PC, Christiaens GCML, Alsbach GPJ. The alkaline hematin method for measuring menstrual blood loss - a modification and its clinical use in menorrhagia. Eur J Obstet Gynecol Reprod Biol 1986;22:345-51.
13. 13. Jacobs A, Miller F, Worwood M, Beamish MR, Wardrop C. Ferritin in the serum of normal subjects and patients with iron deficiency and iron overload. BMJ 1972;4:206-8.
14. 14. Guillebaud J, Barnett J, Gordon YB. Plasma ferritin levels as an index of iron deficiency in women using intrauterine devices. Br J Obstet Gynaecol 1979;86:51-5.
15. 15. Borm GF. Statistical analysis plan of 3-ketodesogestrel/copper medicated IUD study (protocol 36801). December 1995.
16. 16. Siddiqui O, Ali MW. A comparison of the random-effects pattern mixture model with last-observation-carried-forward (LOCF) analysis in longitudinal clinical trials with dropouts. J Biopharm Stat 1998;8:545-63.
17. 17. Tietze C, Lewit S. Recommended procedures for the statistical evaluation of intranterine contraception. Stud Fam Plann 1973; 4:35-42.
18. 18. Potter RG. Use-effectiveness of intrauterine contraception as a problem in competing risks. In: Freedman R, Takeshita J, editors. Family planning in Taiwan. Princeton: Princeton University Press; 1969. p. 458-84.
19. 19. Guillebaud J, Bonnar J. Menstrual blood loss with intrauterine devices. Lancet 1976;1:387-90.
20. 20. Guillebaud J, Bonnar J. Estimation and prediction of IUD-related increased duration and amount of menstrual blood loss. In: Hafez ESE, van Os WAA, editors. Progress in contraceptive delivery systems. Volume 3: IUD pathology and management. Lancaster (UK): MTP Press; 1980. p. 75-92.
21. 21. Guillebaud J, Anderson AB, Turnbull AC. Reduction by mefenamic acid of increased menstrual blood loss associated with intrauterine contraception. Br J Obstet Gynaecol 1978;85:53-62.
22. 22. Edelman A, Berger GS, Keith L. Bleeding. In: Intrauterine devices and their complications. Dordrecht (The Netherlands): Martinus Nijhoff Publishers; 1979. p. 138-57.
23. 23. Nilsson CG, Luukkainen T, Diaz J. Allonen H. Intrauterine contraception with levonorgestrel: a comparative randomized clinical performance study. Lancet 1981;1:577-80.
24. 24. van Os WAA. The Multiload intrauterine device - development and evaluation [dissertation]. Amsterdam: Cloeck en Moedigh; 1987. p. 118.
25. 25. Guillebaud J, Bonnar J. Longer though lighter menstrual bleeding and intermenstrual bleeding with copper as compared to inert intrauterine devices. Br J Obstet Gynaecol 1978;85:707-12.
26. 26. Guilleband J, Bonnar J. Estimation and prediction of IUD-related increased duration and amount of menstrual blood loss. In: Hafez ESE, van Os WAA, editors. Pathology and management. Lancaster (UK): MTP Press; 1980. p. 75-92.
27. 27. Christiaens GCML, Sixma JJ, Haspels AA. Haemostasis in menstrual endometrium in the presence of an intrauterine device. Br J Obstet Gynaecol 1981;88:825-37.