Endometriosis MedDRA version: 15.0 Level: PT Classification code 10014778 Term: Endometriosis System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Trade Name: Visanne
Product Name: Dienogest
Product Code: Bay86-5258
Pharmaceutical Form: Tablet
INN or Proposed INN: DIENOGEST
CAS Number: 65928-58-7
Current Sponsor code: ZK 37659
Concentration unit
Sponsors
Bayer HealthCare AG, Leverkusen, D-51368 Germany
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate safety of dienogest (DNG) in the treatment of endometriosis in adolescents;Secondary Objective: To demonstrate efficacy of dienogest (DNG) in the treatment of endometriosis in adolescents;Primary end point(s): Change in BMD (spine scan) as measured by DEXA after 52 weeks of starting treatment.;Timepoint(s) of evaluation of this end point: From baseline to week 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. BMD on whole body. BMD values and height will also be calculated relative to the age normalized percentiles (Z-scores for BMD) to allow for comparison with historical control groups 2. Percentage of responders at week 24, where a response is defined as a reduction in pain intensity from baseline of at least 30% in the Visual Analogue Scale (VAS) 3. Monthly physician led assessments of the symptoms dysmenorrhea, non menstrual pelvic pain and dyspareunia with the signs pelvic tenderness and induration (full B&B pain grading scale, if specifically agreed by the subject) 4. Global assessment of efficacy based on the CGI scale 5. Haematology (Erythrocytes, Hemoglobin, Hematocrit, Leukocytes, Platelets), Coagulation (PT, aPTT), Blood hemetry, Liver enzymes, Total cholesterol, Triglyceride, HDL, LDL, HbA1c 6. Number of vaginal bleeding events 7. Blood pressure, Pulse 8. Gynecological examinations (pregnancy tests) ;Timepoint(s) of evaluation of this end point: 1. Start of treatment and after 52 weeks. Follow-up 26 weeks after end of treatment in patients with decrease of BMD at end of treatment. 2. At week 24 3. Once in a month over 12 months 4. Four times in 12 months 5. Four times in 12 months 6. Daily assessment during 12 months 7. Five times in 12 months 8. Five times in 12 months (monthly) | — |
Countries
Austria, Czech Republic, Finland, Germany, Spain
Contacts
Public ContactCTP Team/ref:"EU CTR"/
Bayer HealthCare AG
Outcome results
None listed