NCT01283724

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2011

Typical duration for phase_2

Geographic Reach
6 countries

36 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

2 years

First QC Date

January 25, 2011

Last Update Submit

August 12, 2015

Conditions

Endometriosis

Keywords

EndometriosisDEXAAdolescentSafetyEfficacyPost-menarche

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline week 52

Secondary Outcomes (13)

  • Relative Percent Change From Baseline in Whole Body Bone Mineral Density (BMD) at Week 52 Assessed by Dual-Energy X-ray Absorptiometry (DEXA)

    Baseline, Week 52

  • Change From Baseline in Spinal Lumbar Vertebrae 2 to 4 (L2-L4) Z scores at week 52

    Baseline, Week 52

  • Change From Baseline in Whole Body Z-scores at Week 52

    Baseline, Week 52

  • Percentage of Responders at Week 24

    Week 24

  • Change From Baseline in Pelvic Pain Over 52 Weeks Using Modified Biberoglu and Behrman Severity Profile

    Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

  • +8 more secondary outcomes

Study Arms (1)

Dienogest (Visanne, BAY86-5258)

EXPERIMENTAL

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

Drug: Dienogest (Visanne, BAY86-5258)

Interventions

Dienogest (Visanne, BAY86-5258)DRUG

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

Dienogest (Visanne, BAY86-5258)

Eligibility Criteria

Age12 Years - 17 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

Unknown Facility

Sankt Pölten, Lower Austria, 3100, Austria

Location

Unknown Facility

Graz, Styria, 8044, Austria

Location

Unknown Facility

Linz, Upper Austria, 4020, Austria

Location

Unknown Facility

Graz, 8010, Austria

Location

Unknown Facility

Innsbruck, 6020, Austria

Location

Unknown Facility

Vienna, 1060, Austria

Location

Unknown Facility

Vienna, 1090, Austria

Location

Unknown Facility

Brno, 625 00, Czechia

Location

Unknown Facility

České Budějovice, 37001, Czechia

Location

Unknown Facility

Písek, 39701, Czechia

Location

Unknown Facility

Prague, 13000, Czechia

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Espoo, 02100, Finland

Location

Unknown Facility

Helsinki, 00100, Finland

Location

Unknown Facility

Turku, 20100, Finland

Location

Unknown Facility

Angers, 49033, France

Location

Unknown Facility

Le Kremlin-Bicêtre, 94275, France

Location

Unknown Facility

Paris, 75018, France

Location

Unknown Facility

Rouen, 76031, France

Location

Unknown Facility

Erlangen, Bavaria, 91054, Germany

Location

Unknown Facility

Hamburg, Hamburg, 20357, Germany

Location

Unknown Facility

Oldenburg, Lower Saxony, 26121, Germany

Location

Unknown Facility

Westerstede, Lower Saxony, 26655, Germany

Location

Unknown Facility

Münster, North Rhine-Westphalia, 48149, Germany

Location

Unknown Facility

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Unknown Facility

Berlin, State of Berlin, 10117, Germany

Location

Unknown Facility

Berlin, State of Berlin, 12200, Germany

Location

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Berlin, State of Berlin, 12587, Germany

Location

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Berlin, State of Berlin, 13509, Germany

Location

Unknown Facility

Berlin, State of Berlin, 14129, Germany

Location

Unknown Facility

Berlin, State of Berlin, 14193, Germany

Location

Unknown Facility

Benidorm, Alicante, 03503, Spain

Location

Unknown Facility

Vigo, Pontevedra, 36209, Spain

Location

Unknown Facility

Seville, Sevilla, 41013, Spain

Location

Unknown Facility

Valencia, Valencia, 46017, Spain

Location

Unknown Facility

Seville, 41014, Spain

Location

Related Links

MeSH Terms

Conditions

Endometriosis

Interventions

dienogest

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2011

First Posted

January 26, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2013

Study Completion

June 1, 2014

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

DE(12)FI(3)CZ(5)ES(5)AU(7)FR(4)