Long-term vaginal danazol treatment in fertile age women with adenomyosis

Background: The aim of the study was to evaluate the clinical efficacy of long-term vaginal danazol treatment in fertile age women with adenomyosis on pain symptoms and abnormal uterine bleeding (AUB). Methods: A retrospective study on 66 young women with dysmenorrhea and/or dyspareunia, AUB and 2D-ultrasound diagnosis of adenomyosis was conducted at University Hospital of Siena (Italy). Women included were treated with a daily low-dose vaginal danazol (200 mg) for 6 months, followed by 2 different schedules: group A) continuous treatment for further 18 months (n = 30); group B) cyclic intermittent treatment with 3 months’ therapy followed by 3 months’ interval for further 18 months (n = 36). A visual analog scale (VAS) for pain symptoms, a pictorial blood-loss assessment chart (PBAC) for uterine bleeding, 2D-ultrasound signs of adenomyosis and quality-of-life measures were assessed at baseline and after both vaginal progestin regimens. Results: The pain symptoms, PBAC score and uterine volume were significantly reduced (p<0.0001) after 6 months, and the reduction persisted in both group of patients until the end. Mental and physical index score values increased (p<0.0001) in both groups at the end of treatment, with significantly higher mental index scores in intermittent than in continuous treatment (p<0.0001), associated with some drop-out (10%). Conclusions: A long-term treatment with vaginal danazol is effective to control pain and AUB in women with adenomyosis. The 6 months’ treatment followed by a cyclic 3 months’ treatment for further 18 months has the best compliance in symptomatic patients with adenomyosis.