Safety and tolerability of dienogest in endometriosis: pooled analysis from the European clinical study program

• DOI: 10.2147/ijwh.s77202
• Publication Date: 2015-04-15T18:45:35Z
• Authors: Thomas Strowitzki; Thomas Faustmann; Christoph Gerlinger; Ulrike Schumacher; Christiane Ahlers; Christian Seitz
• Keywords: Dienogest; Tolerability; Discontinuation

In four randomized, controlled, European trials, dienogest 2 mg once daily demonstrated significant efficacy for lesion reduction and in pain intensity endometriosis. We describe a pooled analysis of the safety tolerability data from these trials to confirm further characterize profile treatment endometriosis.All 332 women treated with who participated clinical were included analyses assessments, including adverse events, laboratory tests, vital signs, body weight, bleeding patterns. Safety variables analyzed using descriptive statistics.Pooled this large patient population confirmed that is well tolerated, favorable extending over period up 65 weeks The most common drug reactions headache, breast discomfort, depressed mood, acne, each occurring <10% women. All events generally mild-to-moderate associated low discontinuation rates. pattern was only two (0.6%) reported as primary reason premature discontinuation. Laboratory sign assessments indicated no concerns dienogest. Estradiol levels maintained within low-physiological range, support previous evidence indicating demonstrates therapeutic without inducing estradiol deficiency.In endometriosis, tolerated weeks. There paucity randomized trial use many treatments These represent contribution evidence-based medicine providing outcomes potential relevance practice.