check_circleStudy Completed

Endometriosis

Bayer Identifier:

13788

ClinicalTrials.gov Identifier:

NCT01283724

EudraCT Number:

2009-017169-53

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

Female

Age

12 - 17 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
111
Trial Dates
March 2011 - June 2014
Phase
Phase 2
Could I Receive a placebo
No
Products
Visanne (Dienogest, BAY86-5258)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Vivantes Humboldt-KlinikumBerlin, 13509, Germany
Completed
Universitätsklinikum ErlangenErlangen, 91054, Germany
Completed
Charité Campus Benjamin FranklinBerlin, 12200, Germany
Completed
Praxis für FertilitätBerlin, 10117, Germany
Terminated
Martin-Luther-KrankenhausBerlin, 14193, Germany
Terminated
Tagesklinik Altonaer StrasseHamburg, 20357, Germany
Terminated
Ammerland-Klinik GmbHWesterstede, 26655, Germany
Terminated
Universitätsklinikum MünsterMünster, 48149, Germany
Completed
Universitätsklinikum Schleswig-Holstein / AÖRLübeck, 23538, Germany
Terminated
Ordination Dr. Schmidl-AmannSt. Pölten, 3100, Austria
Terminated
Dr. Ewald BoschitschWien, 1060, Austria
Completed
Universitätsklinikum InnsbruckInnsbruck, 6020, Austria
Terminated
Ordination Dr. SchafferGraz, 8044, Austria
Completed
Praxis Dr. Hannes KahrGraz, 8010, Austria
Completed
Allgemeines Krankenhaus der Stadt Wien UniversitätsklinikenWien, 1090, Austria
Completed
Complejo Hospitalario Ntra. Sra. de ValmeSevilla, 41014, Spain
Completed
Hospital Universitario Virgen del RocíoSevilla, 41013, Spain
Completed
Centro de Salud Rincón de LoixBenidorm, 03503, Spain
Terminated
Centro de Planificación Familiar COIAVigo, 36209, Spain
Completed
Terveystalo TurkuTurku, 20100, Finland
Completed
Väestöliitto, Seksuaaliterveysklinikka, HelsinkiHelsinki, 00100, Finland
Completed
Adenova Lääkärikeskus OyEspoo, 02100, Finland
Completed
Gynekologicko-poradnicka ambulance Dr. HlavackovaPisek, 39701, Czech Republic
Completed
Gynekologicka ambulance Vanda Horejsi, MDCeske Budejovice, 37001, Czech Republic
Completed
Fakultni Nemocnice BrnoBrno, 625 00, Czech Republic
Completed
Vseobecna fakultni nemocnicePraha 2, Czech Republic
Completed
Hôpital BicêtreLE KREMLIN BICETRE, 94275, France
Completed
Hôpital Charles Nicolle - Rouen CedexROUEN, 76031, France
Terminated
Hopital Bichat - ParisPARIS, 75018, France
Completed
Femina Sana s.r.oPraha, 13000, Czech Republic
Terminated
Pius-Hospital OldenburgOldenburg, 26121, Germany
Terminated
S + A Klinik für minimal invasive Chirurgie GmbHBerlin, 14129, Germany
Terminated
Centre Hospitalier Universitaire - AngersANGERS CEDEX 01, 49033, France
Terminated
A.ö. Krankenhaus der Stadt LinzLinz, 4020, Austria
Completed
Praxis Fr. Dr. B. HeubergerBerlin, 12587, Germany
Terminated
Hospital Universitario Dr. PesetValencia, 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 52
    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'.
    date_rangeTime Frame:
    Baseline, Week 52
  • Change From Baseline in Whole Body Z-scores at Week 52
    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'.
    date_rangeTime Frame:
    Baseline, Week 52
  • Percentage of Responders at Week 24
    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).
    date_rangeTime Frame:
    Week 24
  • Change From Baseline in Pelvic Pain Over 52 Weeks Using Modified Biberoglu and Behrman Severity Profile
    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.
    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 Profile
    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.
    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 Profile
    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.
    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 Profile
    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.
    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 Profile
    In 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 Profile
    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.
    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 Profile
    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.
    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 Investigator
    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.
    date_rangeTime Frame:
    Weeks 12, 24, 36, and 52
  • Percentage of Subjects With Clinical Global Impression (CGI) Scores -Assessed by the Subject
    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.
    date_rangeTime Frame:
    Weeks 12, 24, 36, 40, and 52

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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