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  • Title: Oestrogen treatment for increased bleeding in Norplant users: preliminary results.
    Author: Witjaksono J, Lau TM, Affandi B, Rogers PA.
    Journal: Hum Reprod; 1996 Oct; 11 Suppl 2():109-14. PubMed ID: 8982752.
    Abstract:
    A clinical study was conducted to assess the effects of oestrogen in controlling increased endometrial bleeding problems in the first year of Norplant use. Three treatment groups were studied: (i) 50 micrograms ethinyl oestradiol (EE); (ii) a combined pill containing 30 micrograms EE and 150 micrograms levonorgestrel (LNG); and (iii) placebo. Based on menstrual diary records, women with prolonged, frequent or irregular bleeding, as defined by World Health Organization criteria, were randomly allocated to one treatment for 21 days. A first endometrial biopsy was taken before commencing treatment and a second biopsy at either day 14 or 21 of treatment. Following treatment, all subjects kept a menstrual diary card for 90 days. In this preliminary study, 48 subjects had completed the full 90 day post-treatment record. Within 21 days of EE treatment, the number of bleeding/spotting days was reduced significantly (P < 0.02). In the 90 days following treatment, the administration of EE and EE + LNG significantly decreased the number of bleeding/spotting days (P < 0.05). There was no reduction in the number of bleeding/spotting episodes in the EE and EE + LNG groups, but the length of each bleeding/spotting episode was significantly shorter (P < 0.05). Histopathological findings of endometrium on day 0 revealed consistent progestogenic effects, and there was no apparent change in response by day 14 or 21 of EE or EE + LNG treatment. The results of this study confirm the clinical effectiveness of EE and EE + LNG for the treatment of irregular, frequent and prolonged bleeding in Norplant users. A clinical study conducted in Indonesia confirmed the effectiveness of ethinyl estradiol and ethinyl estradiol plus levonorgestrel for the treatment of the frequent, prolonged, and irregular bleeding associated with Norplant use. The 91 subjects were randomly allocated to receive, for 3 weeks, 50 mcg of ethinyl estradiol, a combined pill containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel, or a placebo. To date, 48 subjects have completed a 90-day post-treatment menstrual diary. Among this subgroup, only ethinyl estradiol alone reduced significantly (p 0.02) the number of bleeding/spotting days during the 21-day treatment period. In the 90 days after treatment, both ethinyl estradiol and the combined pill significantly (p 0.05) reduced bleeding/spotting compared to the 90 days preceding treatment; moreover, the length of each bleeding/spotting episode was significantly (p 0.05) shorter. Although 84 women completed 2 biopsies (before treatment and at day 14 or 21), adequate endometrial tissue at both time points was obtained from only 33 women. Histopathologic analysis revealed no obvious effect of either ethinyl estradiol or the combination pill on endometrium exposed to the levonorgestrel subdermal implant for an average of 8 months.
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