Oestrogen treatment for increased bleeding in Norplant users: preliminary report

^ o whom correspondence should be addressed 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 ug ethinyl oestradiol (EE); (ii) a combined pill containing 30 \i % EE and 150 ug levonorgestrel (LNG); and (ill) placebo. Based on menstrual diary records, women with pro-longed, 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 men-strual 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 bleed-ing/spotting episodes in the EE and EE+LNG groups, but the length of each bleeding/spotting episode was significantly shorter (P < 0.05). Histopathologlcal 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 treat-ment of irregular, frequent and prolonged bleed-ing in Norplant users. Key words: breakthrough bleeding/endometrium/ ethinyl oestradiol/levonorgestrel/Norplan