A multi-center, open label, single-arm study to investigate the safety and efficacy of daily oral administration of 2 mg dienogest tablets for the treatment of endometriosis in adolescents over a treatment period of 52 weeks - Visanne Study to assess safety in adolescents

Bayer HealthCare AG, Leverkusen, D-51368 Germany0 个研究点目标入组 100 人开始时间: 2011年1月19日最近更新: 2016年4月11日

适应症

试验速览

暂无简介。

•- Female adolescents after menarche (12 – less than 18 years of age) at screening. For Finland: Adolescents aged 12 – 14 years old who present with clinical features of endometriosis will only be enrolled into the study if their diagnosis of endometriosis has been confirmed by laparoscopy
•- Dysmenorrhea of at least moderate intensity, with or without chronic pelvic pain, for at least 2 cycles in the previous 4 months and one of the following conditions:
•-- clinically suspected endometriosis based on the presence of pelvic pain incompletely relieved by non steroidal anti-inflammatory drugs and/or oral contraceptives
•-- Any abdominal pain associated with ultrasound findings suggestive of endometriosis (abdominal, vaginal or rectal; only after additional specific consent and assent)
•-- Failure of surgical treatment for endometriosis (with cyclic or chronic pelvic pain of at least 4 months duration postsurgery)
•-- Threshold for endometriosis-associated pelvic pain (EAPP) score: at least 30 on a 100 units visual analog scale retrospectively evaluated at screening for the last 4 weeks
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 100
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Absence of endometriosis at laparoscopy
•- Previous application of hormonal agents including oral contraceptives within 2 months, progestins, danazol within 3 months, and Gonadotropin Releasing Hormone (GnRH) agonists within 6 months prior to start of treatment
•- Chronic pelvic pain that might be related to genitourinary disease or to chronic or recurrent gastrointestinal disease, including irritable bowel syndrome (defined as a disease characterized by pain relieved by defecation and irregular defecation patterns lasting at least 3 months)
•- Clinically established need for primary surgical treatment of endometriosis

发起方

Bayer HealthCare AG, Leverkusen, D-51368 Germany