Visanne (Dienogest) is a synthetic oral progesterone for treatment of endometrioses.
In a multicenter, double-blind, randomized clinical trial, dienogest was significantly superior to placebo in reducing pelvic pain in patients with confirmed endometrioses. Results were further supported by unchanged intake of rescue medication between groups. The efficacy of dienogest was sustained during treatment up to 12 month in an uncontrolled extension of the pivotal trial.
In addition, the efficacy of dienogest was compared to gonadotrophin- releasing hormone (GnRH) leuprolide in a non-inferiority trial. However, results were not easily interpreted due to absence of a placebo arm.
Dienogest displays a strong progestationel effect hereby inducing endometrial regression with continuous use. Thus, it is associated with high incidence of abnormal bleeding patterns, such as spotting. In addition, it poses a moderate antigonadothropic effect, but no androgenic, glucocorticoid, and mineralocorticoid activity. Despite the high percentage of abnormal bleeding pattern the rate of dropouts was low.
The most frequently reported undesirable effects under treatment with dinogest are headache (9.0%), breast discomfort (5.4%), depressed mood (5.1 %) and acne (5.1 %). No adverse effect on bone mineral density has been measured over a period of 24 weeks by Dexa. However, long-term efficacy and safety is not clear.
IRF consider the efficacy of Visanne (dinogest) in the reduction of endometriosis related pelvic pain is superior to placebo and comparable to gonadotrophin- releasing hormone. The latter has previously been proven equal effective with oral contraceptives and progestagenes, both of which is considerably less expensive than dienogest (up to 13 times). In addition, long-term efficacy > 15 month is not clear.