Visanne Study to Assess Safety in Adolescents

• Register: ClinicalTrials.gov
• Last refreshed on: 24 August 2015
• Main ID: NCT01283724
• Date of registration: 25/01/2011
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Visanne Study to Assess Safety in Adolescents VISADO
• Scientific title: 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
• Date of first enrolment: March 2011
• Target sample size: 111
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01283724
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Austria, Czech Republic, Finland, France, Germany, Spain

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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

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



Age minimum: 12 Years
Age maximum: 17 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Endometriosis

Intervention(s)

Drug: Dienogest (Visanne, BAY86-5258)

Primary Outcome(s)

Relative change in bone mineral density (BMD) of the lumbar spine as assessed by dual energy X-ray absorptiometry (DEXA) [Time Frame: Baseline week 52]

Secondary Outcome(s)

Percentage of Subjects With Dysmenorrhea Over 52 Weeks Using Modified Biberoglu and Behrman Severity Profile [Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

Percentage of Subjects With Pelvic Tenderness Over 52 Weeks Using Modified Biberoglu and Behrman Severity Profile [Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

Change From Baseline in Whole Body Z-scores at Week 52 [Time Frame: Baseline, Week 52]

Change From Baseline in Pelvic Pain Over 52 Weeks Using Modified Biberoglu and Behrman Severity Profile [Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

Percentage of Responders at Week 24 [Time Frame: Week 24]

Percentage of Subjects With Dyspareunia Over 52 Weeks Using Modified Biberoglu and Behrman Severity Profile [Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

Change From Baseline in Spinal Lumbar Vertebrae 2 to 4 (L2-L4) Z scores at week 52 [Time Frame: Baseline, Week 52]

Percentage of Subjects With Induration Over 52 Weeks Using Modified Biberoglu and Behrman Severity Profile [Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

Change From Baseline in Dysmenorrhea Over 52 Weeks Using Modified Biberoglu and Behrman Severity Profile [Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

Percentage of Subjects With Clinical Global Impression (CGI) Scores - Assessed by the Investigator [Time Frame: Weeks 12, 24, 36, and 52]

Percentage of Subjects With Clinical Global Impression (CGI) Scores -Assessed by the Subject [Time Frame: Weeks 12, 24, 36, 40, and 52]

Percentage of Subjects With Pelvic Pain Over 52 Weeks Using Modified Biberoglu and Behrman Severity Profile [Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

Relative Percent Change From Baseline in Whole Body Bone Mineral Density (BMD) at Week 52 Assessed by Dual-Energy X-ray Absorptiometry (DEXA) [Time Frame: Baseline, Week 52]

Secondary ID(s)

2009-017169-53

13788

Source(s) of Monetary Support

Please refer to primary and secondary sponsors