check_circleStudy Completed
Endometriosis
Bayer Identifier:
13788
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Visanne Study to Assess Safety in Adolescents
Trial purpose
A clinical trial which was designed to demonstrate the safety and efficacy of Visanne (approved in endometriosis for adults) in the adolescent population.
Key Participants Requirements
Sex
FemaleAge
12 - 17 YearsTrial summary
Enrollment Goal
111Trial Dates
March 2011 - June 2014Phase
Phase 2Could I Receive a placebo
NoProducts
Visanne (Dienogest, BAY86-5258)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Terminated | Vivantes Humboldt-Klinikum | Berlin, 13509, Germany |
Completed | Universitätsklinikum Erlangen | Erlangen, 91054, Germany |
Completed | Charité Campus Benjamin Franklin | Berlin, 12200, Germany |
Completed | Praxis für Fertilität | Berlin, 10117, Germany |
Terminated | Martin-Luther-Krankenhaus | Berlin, 14193, Germany |
Terminated | Tagesklinik Altonaer Strasse | Hamburg, 20357, Germany |
Terminated | Ammerland-Klinik GmbH | Westerstede, 26655, Germany |
Terminated | Universitätsklinikum Münster | Münster, 48149, Germany |
Completed | Universitätsklinikum Schleswig-Holstein / AÖR | Lübeck, 23538, Germany |
Terminated | Ordination Dr. Schmidl-Amann | St. Pölten, 3100, Austria |
Terminated | Dr. Ewald Boschitsch | Wien, 1060, Austria |
Completed | Universitätsklinikum Innsbruck | Innsbruck, 6020, Austria |
Terminated | Ordination Dr. Schaffer | Graz, 8044, Austria |
Completed | Praxis Dr. Hannes Kahr | Graz, 8010, Austria |
Completed | Allgemeines Krankenhaus der Stadt Wien Universitätskliniken | Wien, 1090, Austria |
Completed | Complejo Hospitalario Ntra. Sra. de Valme | Sevilla, 41014, Spain |
Completed | Hospital Universitario Virgen del Rocío | Sevilla, 41013, Spain |
Completed | Centro de Salud Rincón de Loix | Benidorm, 03503, Spain |
Terminated | Centro de Planificación Familiar COIA | Vigo, 36209, Spain |
Completed | Terveystalo Turku | Turku, 20100, Finland |
Completed | Väestöliitto, Seksuaaliterveysklinikka, Helsinki | Helsinki, 00100, Finland |
Completed | Adenova Lääkärikeskus Oy | Espoo, 02100, Finland |
Completed | Gynekologicko-poradnicka ambulance Dr. Hlavackova | Pisek, 39701, Czech Republic |
Completed | Gynekologicka ambulance Vanda Horejsi, MD | Ceske Budejovice, 37001, Czech Republic |
Completed | Fakultni Nemocnice Brno | Brno, 625 00, Czech Republic |
Completed | Vseobecna fakultni nemocnice | Praha 2, Czech Republic |
Completed | Hôpital Bicêtre | LE KREMLIN BICETRE, 94275, France |
Completed | Hôpital Charles Nicolle - Rouen Cedex | ROUEN, 76031, France |
Terminated | Hopital Bichat - Paris | PARIS, 75018, France |
Completed | Femina Sana s.r.o | Praha, 13000, Czech Republic |
Terminated | Pius-Hospital Oldenburg | Oldenburg, 26121, Germany |
Terminated | S + A Klinik für minimal invasive Chirurgie GmbH | Berlin, 14129, Germany |
Terminated | Centre Hospitalier Universitaire - Angers | ANGERS CEDEX 01, 49033, France |
Terminated | A.ö. Krankenhaus der Stadt Linz | Linz, 4020, Austria |
Completed | Praxis Fr. Dr. B. Heuberger | Berlin, 12587, Germany |
Terminated | Hospital Universitario Dr. Peset | Valencia, 46017, Spain |
Primary Outcome
- Relative change in bone mineral density (BMD) of the lumbar spine as assessed by dual energy X-ray absorptiometry (DEXA)The measurement of BMD by DEXA is the gold standard method for investigation of bone mass.date_rangeTime Frame:Baseline week 52
Secondary Outcome
- Relative Percent Change From Baseline in Whole Body Bone Mineral Density (BMD) at Week 52 Assessed by Dual-Energy X-ray Absorptiometry (DEXA)The measurement of BMD by DEXA is the gold standard method for investigation of bone mass.date_rangeTime Frame:Baseline, Week 52
- Change From Baseline in Spinal Lumbar Vertebrae 2 to 4 (L2-L4) Z scores at week 52Based 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'.date_rangeTime Frame:Baseline, Week 52
- Change From Baseline in Whole Body Z-scores at Week 52Based 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'.date_rangeTime Frame:Baseline, Week 52
- Percentage of Responders at Week 24Responders 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).date_rangeTime Frame:Week 24
- Change From Baseline in Pelvic Pain Over 52 Weeks Using Modified Biberoglu and Behrman Severity ProfileThe 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.date_rangeTime 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 ProfileThe 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.date_rangeTime Frame:Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
- Percentage of Subjects With Pelvic Pain Over 52 Weeks Using Modified Biberoglu and Behrman Severity ProfileIn 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.date_rangeTime Frame:Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
- Percentage of Subjects With Dysmenorrhea Over 52 Weeks Using Modified Biberoglu and Behrman Severity ProfileIn 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.date_rangeTime Frame:Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
- Percentage of Subjects With Dyspareunia Over 52 Weeks Using Modified Biberoglu and Behrman Severity ProfileIn order to judge therapeutic effectiveness and to compare subjects’ complaints, a severity profile score of dyspareunia was assessed using a rating scale.date_rangeTime 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 ProfileIn 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.date_rangeTime Frame:Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
- Percentage of Subjects With Induration Over 52 Weeks Using Modified Biberoglu and Behrman Severity ProfileIn 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.date_rangeTime 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 InvestigatorThe 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.date_rangeTime Frame:Weeks 12, 24, 36, and 52
- Percentage of Subjects With Clinical Global Impression (CGI) Scores -Assessed by the SubjectThe 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.date_rangeTime Frame:Weeks 12, 24, 36, 40, and 52
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1Additional Information
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