Trial Condition(s):

Endometriosis

Visanne Study to Assess Safety in Adolescents (VISADO)

Bayer Identifier:

13788

ClinicalTrials.gov Identifier:

NCT01283724

EudraCT Number:

2009-017169-53

Study Completed

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.

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

Trial Summary

Enrollment Goal
111
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Visanne (Dienogest, BAY86-5258)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Vivantes Humboldt-Klinikum

Berlin, Germany, 13509

Status
Terminated
 
Locations

Universitätsklinikum Erlangen

Erlangen, Germany, 91054

Status
Completed
 
Locations

Charité Campus Benjamin Franklin

Berlin, Germany, 12200

Status
Completed
 
Locations

Praxis für Fertilität

Berlin, Germany, 10117

Status
Completed
 
Locations

Martin-Luther-Krankenhaus

Berlin, Germany, 14193

Status
Terminated
 
Locations

Tagesklinik Altonaer Strasse

Hamburg, Germany, 20357

Status
Terminated
 
Locations

Ammerland-Klinik GmbH

Westerstede, Germany, 26655

Status
Terminated
 
Locations

Universitätsklinikum Münster

Münster, Germany, 48149

Status
Terminated
 
Locations

Universitätsklinikum Schleswig-Holstein / AÖR

Lübeck, Germany, 23538

Status
Completed
 
Locations

Ordination Dr. Schmidl-Amann

St. Pölten, Austria, 3100

Status
Terminated
 
Locations

Dr. Ewald Boschitsch

Wien, Austria, 1060

Status
Terminated
 
Locations

Universitätsklinikum Innsbruck

Innsbruck, Austria, 6020

Status
Completed
 
Locations

Ordination Dr. Schaffer

Graz, Austria, 8044

Status
Terminated
 
Locations

Praxis Dr. Hannes Kahr

Graz, Austria, 8010

Status
Completed
 
Locations

Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

Status
Completed
 
Locations

Complejo Hospitalario Ntra. Sra. de Valme

Sevilla, Spain, 41014

Status
Completed
 
Locations

Hospital Universitario Virgen del Rocío

Sevilla, Spain, 41013

Status
Completed
 
Locations

Centro de Salud Rincón de Loix

Benidorm, Spain, 03503

Status
Completed
 
Locations

Centro de Planificación Familiar COIA

Vigo, Spain, 36209

Status
Terminated
 
Locations

Terveystalo Turku

Turku, Finland, 20100

Status
Completed
 
Locations

Väestöliitto, Seksuaaliterveysklinikka, Helsinki

Helsinki, Finland, 00100

Status
Completed
 
Locations

Adenova Lääkärikeskus Oy

Espoo, Finland, 02100

Status
Completed
 
Locations

Gynekologicko-poradnicka ambulance Dr. Hlavackova

Pisek, Czech Republic, 39701

Status
Completed
 
Locations

Gynekologicka ambulance Vanda Horejsi, MD

Ceske Budejovice, Czech Republic, 37001

Status
Completed
 
Locations

Fakultni Nemocnice Brno

Brno, Czech Republic, 625 00

Status
Completed
 
Locations

Vseobecna fakultni nemocnice

Praha 2, Czech Republic

Status
Completed
 
Locations

Hôpital Bicêtre

LE KREMLIN BICETRE, France, 94275

Status
Completed
 
Locations

Hôpital Charles Nicolle - Rouen Cedex

ROUEN, France, 76031

Status
Completed
 
Locations

Hopital Bichat - Paris

PARIS, France, 75018

Status
Terminated
 
Locations

Femina Sana s.r.o

Praha, Czech Republic, 13000

Status
Completed
 
Locations

Pius-Hospital Oldenburg

Oldenburg, Germany, 26121

Status
Terminated
 
Locations

S + A Klinik für minimal invasive Chirurgie GmbH

Berlin, Germany, 14129

Status
Terminated
 
Locations

Centre Hospitalier Universitaire - Angers

ANGERS CEDEX 01, France, 49033

Status
Terminated
 
Locations

A.ö. Krankenhaus der Stadt Linz

Linz, Austria, 4020

Status
Terminated
 
Locations

Praxis Fr. Dr. B. Heuberger

Berlin, Germany, 12587

Status
Completed
 
Locations

Hospital Universitario Dr. Peset

Valencia, Spain, 46017

Status
Terminated
 

Trial Design