Visanne Study to Assess Safety in Adolescents (VISADO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01283724
First received: January 25, 2011
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Endometriosis
Drug: Dienogest (Visanne, BAY86-5258)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Relative change in bone mineral density (BMD) of the lumbar spine as assessed by dual energy X-ray absorptiometry (DEXA) [ Time Frame: From baseline to week 52 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Start of treatment and after 52 weeks ] [ Designated as safety issue: Yes ]
  • 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) [ Time Frame: At week 24 ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: Once in a month over 12 months ] [ Designated as safety issue: No ]
  • Global assessment of efficacy based on the CGI scale [ Time Frame: Four times in 12 months ] [ Designated as safety issue: No ]
  • Haematology (Erythrocytes, Hemoglobin, Hematocrit, Leukocytes, Platelets), Coagulation (PT, aPTT), Blood chemistry, Liver enzymes, Total cholesterol, Triglyceride, HDL, LDL, HbA1c [ Time Frame: Four times in 12 months ] [ Designated as safety issue: Yes ]
  • Number of vaginal bleeding events [ Time Frame: Daily assessment during 12 months ] [ Designated as safety issue: Yes ]
  • Blood pressure, Pulse [ Time Frame: Five times in 12 months ] [ Designated as safety issue: Yes ]
  • Gynecological examinations (pregnancy tests) [ Time Frame: Five times in 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 111
Study Start Date: March 2011
Study Completion Date: June 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dienogest Drug: Dienogest (Visanne, BAY86-5258)
Daily oral intake of Dienogest 2 mg for 52 weeks

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283724

Locations
Austria
St. Pölten, Niederösterreich, Austria, 3100
Linz, Oberösterreich, Austria, 4020
Graz, Steiermark, Austria, 8044
Graz, Austria, 8010
Innsbruck, Austria, 6020
Wien, Austria, 1060
Wien, Austria, 1090
Czech Republic
Brno, Czech Republic, 625 00
Ceske Budejovice, Czech Republic, 37001
Pisek, Czech Republic, 39701
Praha, Czech Republic, 13000
Praha 2, Czech Republic
Finland
Espoo, Finland, 02100
Helsinki, Finland, 00100
Turku, Finland, 20100
France
Angers Cedex 01, France, 49033
Le Kremlin Bicetre, France, 94275
Paris, France, 75018
Rouen, France, 76031
Germany
Erlangen, Bayern, Germany, 91054
Oldenburg, Niedersachsen, Germany, 26121
Westerstede, Niedersachsen, Germany, 26655
Münster, Nordrhein-Westfalen, Germany, 48149
Lübeck, Schleswig-Holstein, Germany, 23538
Berlin, Germany, 14129
Berlin, Germany, 12587
Berlin, Germany, 12200
Berlin, Germany, 10117
Berlin, Germany, 13509
Berlin, Germany, 14193
Hamburg, Germany, 20357
Spain
Benidorm, Alicante, Spain, 03503
Vigo, Pontevedra, Spain, 36209
Sevilla, Spain, 41014
Sevilla, Spain, 41013
Valencia, Spain, 46017
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01283724     History of Changes
Other Study ID Numbers: 13788, 2009-017169-53
Study First Received: January 25, 2011
Last Updated: June 3, 2014
Health Authority: Austria: Agency for Health and Food Safety
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines

Keywords provided by Bayer:
Endometriosis
DEXA
Adolescent
Safety
Efficacy
Post-menarche

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Dienogest
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral
Contraceptive Agents, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 01, 2014