Tamoxifen treatment of bleeding irregularities associated with Norplant use.
OBJECTIVE
To evaluate the possible role of tamoxifen (selective estrogen receptor modulators, SERM) in treating bleeding irregularities associated with Norplant contraceptive use.


METHODS
Randomized clinical trial including 100 Norplant users complaining of vaginal bleeding irregularities. The trial was conducted in the Family Planning Clinic of Assiut University Hospital. Women were assigned at random to receive tamoxifen tablets (10 mg) twice daily for 10 days or similar placebo. Women were followed-up for 3 months. The end points were percentage of women who stopped bleeding during treatment, bleeding/spotting days during the period of follow-up, effect of treatment on their lifestyle, and side effects and discontinuation of contraception.


RESULTS
There was good compliance with treatment. At the end of treatment, a significantly higher percentage of tamoxifen users stopped bleeding in comparison to the control group (88% vs. 68%, respectively; p=.016). Women who used tamoxifen had significantly less bleeding and/or spotting days than women who used placebo, during the first and second months. During the third month, there were no significant differences between the two groups. Women who used tamoxifen reported improvement in performing household activities, religious duties and in sexual life, during the first 2 months. In the third month, there were no differences between the two groups. There were no significant differences between tamoxifen and placebo groups in reporting side effects. In the group who used tamoxifen, two women discontinued Norplant use because of bleeding vs. nine women in the placebo group.


CONCLUSIONS
Tamoxifen use at a dose of 10 mg twice daily orally, for 10 days, has a beneficial effect on vaginal bleeding associated with Norplant use. In addition, the bleeding pattern was better in women who used tamoxifen for the following 2 months after treatment. However, these results have to be confirmed in a larger trial before advocating this line of treatment.
Abdel-Aleem
Hany
H
Department of Obstetrics and Gynecology, Assiut University Hospital, Assiut 71511, Egypt. aleemh@yahoo.com
Shaaban
Omar M
OM
Amin
Ahmed F
AF
Abdel-Aleem
Aly M
AM
D000328:Adult; D004311:Double-Blind Method; D004965:Estrogen Antagonists / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000009:adverse effects*; D010919:Placebos; D013629:Tamoxifen / Q000627:therapeutic use*; D014592:Uterine Hemorrhage / Q000188:drug therapy* / Q000209:etiology*
D004965:Estrogen Antagonists; D010919:Placebos; D013629:Tamoxifen; D016912:Levonorgestrel