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Visanne Study to Assess Safety in Adolescents

NCT01283724 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2015-08-13

No results posted yet for this study

Summary

A clinical trial which was designed to demonstrate the safety and efficacy of Visanne (approved in endometriosis for adults) in the adolescent population.

Conditions

  • Endometriosis

Interventions

DRUG

Dienogest (Visanne, BAY86-5258)

Subjects received Dienogest tablet orally at a dosage of 2 mg once daily over a period of 52 weeks.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-03-31
Completion
2014-06-30

Countries

  • Austria
  • Czechia
  • Finland
  • France
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01283724 on ClinicalTrials.gov