- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01283724
Visanne Study to Assess Safety in Adolescents (VISADO)
August 12, 2015 updated by: Bayer
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
A clinical trial which was designed to demonstrate the safety and efficacy of Visanne (approved in endometriosis for adults) in the adolescent population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
111
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Graz, Austria, 8010
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Innsbruck, Austria, 6020
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Wien, Austria, 1090
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Wien, Austria, 1060
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Niederösterreich
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St. Pölten, Niederösterreich, Austria, 3100
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Oberösterreich
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Linz, Oberösterreich, Austria, 4020
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Steiermark
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Graz, Steiermark, Austria, 8044
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Brno, Czech Republic, 625 00
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Ceske Budejovice, Czech Republic, 37001
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Pisek, Czech Republic, 39701
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Praha, Czech Republic, 13000
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Praha 2, Czech Republic
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Espoo, Finland, 02100
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Helsinki, Finland, 00100
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Turku, Finland, 20100
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Angers Cedex 01, France, 49033
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Le Kremlin Bicetre, France, 94275
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Paris, France, 75018
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Rouen, France, 76031
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Berlin, Germany, 10117
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Berlin, Germany, 12200
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Berlin, Germany, 12587
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Berlin, Germany, 13509
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Berlin, Germany, 14129
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Berlin, Germany, 14193
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Hamburg, Germany, 20357
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Bayern
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Erlangen, Bayern, Germany, 91054
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Niedersachsen
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Oldenburg, Niedersachsen, Germany, 26121
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Westerstede, Niedersachsen, Germany, 26655
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Nordrhein-Westfalen
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Münster, Nordrhein-Westfalen, Germany, 48149
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Germany, 23538
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Sevilla, Spain, 41014
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Sevilla, Spain, 41013
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Valencia, Spain, 46017
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Alicante
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Benidorm, Alicante, Spain, 03503
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Pontevedra
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Vigo, Pontevedra, Spain, 36209
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Dienogest (Visanne, BAY86-5258)
Subjects received Dienogest tablet orally at a dosage of 2 mg once daily over a period of 52 weeks.
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Subjects received Dienogest tablet orally at a dosage of 2 mg once daily over a period of 52 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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The measurement of BMD by DEXA is the gold standard method for investigation of bone mass.
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Baseline week 52
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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The measurement of BMD by DEXA is the gold standard method for investigation of bone mass.
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Baseline, Week 52
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Change From Baseline in Spinal Lumbar Vertebrae 2 to 4 (L2-L4) Z scores at week 52
Time Frame: Baseline, Week 52
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Based on the BMD values and the weight, the age-normalized percentiles (Z-scores) were determined to allow for comparison with historical control groups.
"No difference" in comparison with the historical control groups was defined as a Z-score between '-0.5' and '0.5', a lower value was defined as a value below '-0.5', and a higher value above '0.5'.
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Baseline, Week 52
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Change From Baseline in Whole Body Z-scores at Week 52
Time Frame: Baseline, Week 52
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Based on the BMD values and the weight, the age-normalized percentiles (Z-scores) were determined to allow for comparison with historical control groups.
"No difference" in comparison with the historical control groups was defined as a Z-score between '-0.5' and '0.5', a lower value was defined as a value below '-0.5', and a higher value above '0.5'.
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Baseline, Week 52
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Percentage of Responders at Week 24
Time Frame: Week 24
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Responders were defined as subjects with reduction in pain intensity from baseline of at least 30% in the Visual Analog Scale (VAS) at Week 24.
VAS consisted of a 100 unit long straight line, with verbal anchors at either end, representing a continuum of pain intensity.
One end of the line with 0 score as "absence of pain" while the other end of the line with 100 score as "unbearable pain".
The assessment of pelvic pain on a VAS was done once every 4 weeks till the end of the treatment (Week 52).
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Week 24
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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
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The cardinal symptoms inlcuded in the modified Biberoglu and Behrman severity profile were pelvic pain, dysmenorrhea, and dyspareunia (the latter only in those subjects having sexual intercourse), analyzed at all visits with symptom severity scores from 0 (none) to 3 (severe).
Negative value for change from baseline indicates an improvement.
In the listed categories, 'N' signifies those subjects who were evaluable for this measure.
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Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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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
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The cardinal symptoms inlcuded in the modified Biberoglu and Behrman severity profile were pelvic pain, dysmenorrhea, and dyspareunia (the latter only in those subjects having sexual intercourse), analyzed at all visits with symptom severity scores from 0 (none) to 3 (severe).
Negative value for change from baseline indicates an improvement.
In the listed categories, 'N' signifies those subjects who were evaluable for this measure.
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Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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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
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In order to judge therapeutic effectiveness and to compare subjects' complaints, a severity profile score of pelvic pain was assessed using a rating scale: missing; 0 = none; 1 = mild (occasional pelvic discomfort); 2 = moderate (noticeable discomfort for most of the cycle); 3 = severe (requires strong analgesics and persists during cycle when not menstruating) based on the subject's self-assessment of symptoms.
In the listed categories, 'N' signifies those subjects who were evaluable for this measure.
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Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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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
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In order to judge therapeutic effectiveness and to compare subjects' complaints, a severity profile score of dysmenorrhea was assessed using a rating scale: missing; 0 = none; 1 = mild (some loss in work efficiency); 2 = moderate (in bed part of day, occasional loss of work efficiency); 3 = severe (in bed one or more days, incapacitation) based on the subject's self-assessment of symptoms.
In the listed categories, 'N' signifies those subjects who were evaluable for this measure.
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Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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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
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In order to judge therapeutic effectiveness and to compare subjects' complaints, a severity profile score of dyspareunia was assessed using a rating scale.
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Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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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
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In order to judge therapeutic effectiveness and to compare subjects' complaints, a severity profile score of pelvic tenderness was assessed using a rating scale: missing; 0 = none (no pain during intercourse); 1 = mild (minimal tenderness on palpation); 2 = moderate (extensive tenderness on palpation); 3 = severe (unable to palpate because of tenderness) based on the gynecological palpation by the attending physician.
In the listed categories, 'N' signifies those subjects who were evaluable for this measure.
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Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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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
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In order to judge therapeutic effectiveness and to compare subjects' complaints, a severity profile score of induration was assessed using a rating scale: missing; 0 = none (no pain during intercourse); 1 = mild (uterus freely mobile, induration in the cul-de-sac); 2 = moderate (thickened and indurated adnexa and cul-de-sac, restricted uterine mobility); 3 = severe (nodular adnexa and cul-de-sac, uterus frequently frozen) based on the gynecological palpation by the attending physician.
In the listed categories, 'N' signifies those subjects who were evaluable for this measure.
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Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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Percentage of Subjects With Clinical Global Impression (CGI) Scores - Assessed by the Investigator
Time Frame: Weeks 12, 24, 36, and 52
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The investigator rating scale used in this study was based on the validated CGI scale, which is widely used as a simple tool to assess the overall effect of treatments.
The investigator or a sub-investigator rated the total improvement according to the following scale: Score 1 = very much improved; Score 2 =much improved; Score 3 = minimally improved; Score 4 = no change; Score 5 = minimally worse; Score 6 = much worse; Score 7 = very much worse.
None of the subjects reported Score 7. In the listed categories, 'N' signifies those subjects who were evaluable for this measure.
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Weeks 12, 24, 36, and 52
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Percentage of Subjects With Clinical Global Impression (CGI) Scores -Assessed by the Subject
Time Frame: Weeks 12, 24, 36, 40, and 52
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The subject rating scale used in this study was based on the validated CGI scale, which is widely used as a simple tool to assess the overall effect of treatments.
The subject was asked to rate her satisfaction with the study treatment according to the following scale: Score 1 = very much satisfied; Score 2 = much satisfied; Score 3 = minimally satisfied; Score 4 = neither satisfied nor dissatisfied; Score 5 =minimally dissatisfied; Score 6 = much dissatisfied; Score 7 = very much dissatisfied.
In the listed categories, 'N' signifies those subjects who were evaluable for this measure.
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Weeks 12, 24, 36, 40, and 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
January 25, 2011
First Submitted That Met QC Criteria
January 25, 2011
First Posted (Estimate)
January 26, 2011
Study Record Updates
Last Update Posted (Estimate)
August 13, 2015
Last Update Submitted That Met QC Criteria
August 12, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endometriosis
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Hormonal
- Contraceptive Agents, Male
- Dienogest
Other Study ID Numbers
- 13788
- 2009-017169-53 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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