NCT00225186

Brief Summary

The purpose of this study is to demonstrate safety and efficacy of SH T00660AA for the treatment of endometriosis

Trial Health

90
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2004

Typical duration for phase_3

Geographic Reach
3 countries

28 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

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

3.7 years

First QC Date

September 22, 2005

Last Update Submit

January 8, 2014

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

  • Safety assessment of the drug

    12-18 months

Secondary Outcomes (1)

  • Efficacy (reduction of pelvic pain)

    12-18 months

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Visanne (SH T00660AA , BAY86-5258)

Interventions

Visanne (SH T00660AA , BAY86-5258)DRUG

Daily long-term drug treatment (12 months), and post-treatment observation (6 months) in a subgroup of patients

Arm 1

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female patients with endometriosis-associated pelvic pain

You may not qualify if:

  • Pregnant or lactating women
  • History or suspicion of hormone dependent tumor
  • Therapy resistant endometriosis or need for primary surgical treatment
  • Any other conditions which forbid the participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Unknown Facility

Heidelberg, Baden-Wurttemberg, 69115, Germany

Location

Unknown Facility

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Unknown Facility

Krumbach, Bavaria, 86381, Germany

Location

Unknown Facility

München, Bavaria, 81241, Germany

Location

Unknown Facility

Nuremberg, Bavaria, 90419, Germany

Location

Unknown Facility

Giessen, Hesse, 35392, Germany

Location

Unknown Facility

Mühlheim am Main, Hesse, 63165, Germany

Location

Unknown Facility

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Unknown Facility

Gevelsberg, North Rhine-Westphalia, 58285, Germany

Location

Unknown Facility

Münster, North Rhine-Westphalia, 48129, Germany

Location

Unknown Facility

Dippoldiswalde, Saxony, 01744, Germany

Location

Unknown Facility

Leipzig, Saxony, 04103, Germany

Location

Unknown Facility

Marienberg, Saxony, 09496, Germany

Location

Unknown Facility

Weißig, Saxony, 01474, Germany

Location

Unknown Facility

Kalbe, Saxony-Anhalt, 39624, Germany

Location

Unknown Facility

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Unknown Facility

Greifswald, 17487, Germany

Location

Unknown Facility

Brescia, 25123, Italy

Location

Unknown Facility

Cagliari, 09042, Italy

Location

Unknown Facility

Napoli, 80138, Italy

Location

Unknown Facility

Roma, 00165, Italy

Location

Unknown Facility

Torino, 10127, Italy

Location

Unknown Facility

Chernivtsi, 58017, Ukraine

Location

Unknown Facility

Kiev, 01030, Ukraine

Location

Unknown Facility

Kiev, 04050, Ukraine

Location

Unknown Facility

Kiev, 04107, Ukraine

Location

Unknown Facility

Kiev, 04210, Ukraine

Location

Unknown Facility

Vinnitsa, 21000, Ukraine

Location

Related Publications (4)

  • Strowitzki T, Faustmann T, Gerlinger C, Seitz C. Dienogest in the treatment of endometriosis-associated pelvic pain: a 12-week, randomized, double-blind, placebo-controlled study. Eur J Obstet Gynecol Reprod Biol. 2010 Aug;151(2):193-8. doi: 10.1016/j.ejogrb.2010.04.002. Epub 2010 May 5.

    PMID: 20444534RESULT

  • Kohler G, Faustmann TA, Gerlinger C, Seitz C, Mueck AO. A dose-ranging study to determine the efficacy and safety of 1, 2, and 4mg of dienogest daily for endometriosis. Int J Gynaecol Obstet. 2010 Jan;108(1):21-5. doi: 10.1016/j.ijgo.2009.08.020.

    PMID: 19819448RESULT

  • Gerlinger C, Schumacher U, Faustmann T, Colligs A, Schmitz H, Seitz C. Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials. Health Qual Life Outcomes. 2010 Nov 24;8:138. doi: 10.1186/1477-7525-8-138.

    PMID: 21106059RESULT

  • Petraglia F, Hornung D, Seitz C, Faustmann T, Gerlinger C, Luisi S, Lazzeri L, Strowitzki T. Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment. Arch Gynecol Obstet. 2012 Jan;285(1):167-73. doi: 10.1007/s00404-011-1941-7. Epub 2011 Jun 17.

    PMID: 21681516RESULT

MeSH Terms

Conditions

Endometriosis

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 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2005

First Posted

September 23, 2005

Study Start

July 1, 2004

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

IT(5)DE(17)UA(6)