Visanne Study to Assess Safety in Adolescents (VISADO)
This study is ongoing, but not recruiting participants.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01283724
First received: January 25, 2011
Last updated: September 19, 2012
Last verified: September 2012
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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: | Allocation: Non-Randomized 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 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
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
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 Cedex, 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: | Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT01283724 History of Changes |
| Other Study ID Numbers: | 13788, 2009-017169-53 |
| Study First Received: | January 25, 2011 |
| Last Updated: | September 19, 2012 |
| 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 Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptive Agents, Male |
ClinicalTrials.gov processed this record on September 26, 2012
