Abnormal uterine bleeding: medical treatment with vaginal danazol and five-year follow-up

Study Objective. To evaluate the clinical efficacy and patient satisfaction of long-term danazol delivered vaginally as treatment for heavy menstrual bleeding. Design. Prospective study (Canadian Task Force classification II-3). Setting. University hospital. Patients. Twenty premenopausal women with endometrial hyperplasia or endometrial polyps. Intervention. After curettage or hysteroscopic-directed biopsies, women used one 200-mg tablet of danazol vaginally every day, continuing the therapy as long as they were totally satisfied with it. Measurements and Main Results. Women were instructed to keep a diary of menstrual bleeding and to rate blood loss on a visual analog scale from zero (no blood loss) to 10 (gushing-type bleeding). They were seen every month for 3 months, then every 3 months for 9 months, and then every 6 months for 4 years for Papanicolau smear, pelvic examination, and transvaginal ultrasonography. They were asked to bring their diary of menstrual bleeding. They were asked about side effects and their satisfaction with the therapy. Peripheral blood was drawn for blood count and serum chemistries. Hysteroscopic-directed biopsies were repeated after 3 months of therapy in women with endometrial hyperplasia. The severity of blood loss was significantly reduced in all women after 3 months of treatment. All women with endometrial hyperplasia had regression of hyperplastic endometrium. None of the women with endometrial polyps had sonographic signs of recurrence during therapy. Only 10 women (50%) completed 1-year follow-up, and only 5 women (25%) completed 5-year follow-up. Conclusion. These results suggest that long-term administration of vaginal danazol after curettage or hysteroscopic-directed biopsy is both efficacious and safe in women with heavy menstrual bleeding, but the rate of discontinuance is high.