Clinical trial NCT01283724: Visanne Study to Assess Safety in Adolescents
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Keywords: Endometriosis
DEXA
Adolescent
Safety
Efficacy
Post-menarche
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-01-26
Enrollment: 111
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A clinical trial which was designed to demonstrate the safety and efficacy of Visanne (approved in endometriosis for adults) in the adolescent population.


Eligibility 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

Primary outcomes:
measure: Relative change in bone mineral density (BMD) of the lumbar spine as assessed by dual energy X-ray absorptiometry (DEXA)
timeFrame: Baseline week 52
Secondary outcomes:
measure: Relative Percent Change From Baseline in Whole Body Bone Mineral Density (BMD) at Week 52 Assessed by Dual-Energy X-ray Absorptiometry (DEXA)
timeFrame: Baseline, Week 52
measure: Change From Baseline in Spinal Lumbar Vertebrae 2 to 4 (L2-L4) Z scores at week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Whole Body Z-scores at Week 52
timeFrame: Baseline, Week 52
measure: Percentage of Responders at Week 24
timeFrame: Week 24
measure: Change From Baseline in Pelvic Pain Over 52 Weeks Using Modified Biberoglu and Behrman Severity Profile
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Change From Baseline in Dysmenorrhea Over 52 Weeks Using Modified Biberoglu and Behrman Severity Profile
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Percentage of Subjects With Pelvic Pain Over 52 Weeks Using Modified Biberoglu and Behrman Severity Profile
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Percentage of Subjects With Dysmenorrhea Over 52 Weeks Using Modified Biberoglu and Behrman Severity Profile
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Percentage of Subjects With Dyspareunia Over 52 Weeks Using Modified Biberoglu and Behrman Severity Profile
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Percentage of Subjects With Pelvic Tenderness Over 52 Weeks Using Modified Biberoglu and Behrman Severity Profile
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Percentage of Subjects With Induration Over 52 Weeks Using Modified Biberoglu and Behrman Severity Profile
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Percentage of Subjects With Clinical Global Impression (CGI) Scores - Assessed by the Investigator
timeFrame: Weeks 12, 24, 36, and 52
measure: Percentage of Subjects With Clinical Global Impression (CGI) Scores -Assessed by the Subject
timeFrame: Weeks 12, 24, 36, 40, and 52
Other outcomes:
Locations:
city: St. Pölten
country: Austria
state: Niederösterreich
city: Linz
country: Austria
state: Oberösterreich
city: Graz
country: Austria
state: Steiermark
city: Graz
country: Austria
city: Innsbruck
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Brno
country: Czech Republic
city: Ceske Budejovice
country: Czech Republic
city: Pisek
country: Czech Republic
city: Praha 2
country: Czech Republic
city: Praha
country: Czech Republic
city: Espoo
country: Finland
city: Helsinki
country: Finland
city: Turku
country: Finland
city: Angers Cedex 01
country: France
city: Le Kremlin Bicetre
country: France
city: Paris
country: France
city: Rouen
country: France
city: Erlangen
country: Germany
state: Bayern
city: Oldenburg
country: Germany
state: Niedersachsen
city: Westerstede
country: Germany
state: Niedersachsen
city: Münster
country: Germany
state: Nordrhein-Westfalen
city: Lübeck
country: Germany
state: Schleswig-Holstein
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Benidorm
country: Spain
state: Alicante
city: Vigo
country: Spain
state: Pontevedra
city: Sevilla
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: