NCT00225199

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2004

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

March 1, 2004

Completed
1.6 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
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

April 23, 2010

Status Verified

April 1, 2010

First QC Date

September 22, 2005

Last Update Submit

April 22, 2010

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

  • Efficacy

    Assessment of pain relief at end of treatment

Secondary Outcomes (2)

  • Adverse event collection

    Assessment at end of study

  • Treatment satisfaction by patient

    Assessment at end of study

Study Arms (2)

Arm 1

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

Arm 2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Visanne (BAY86-5258, SH T00660AA)DRUG

orally once daily

Arm 1
PlaceboDRUG

orally once daily

Arm 2

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
  • need for primary surgical treatment
  • any other conditions which forbid the participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sieverding M, Gerlinger C, Seitz C. Substituting a randomised placebo control group with a historical placebo control in an endometriosis pain trial: a case study re-evaluating trial data using historical control data from another trial. BMJ Open. 2023 Jul 21;13(7):e063188. doi: 10.1136/bmjopen-2022-063188.

    PMID: 37479520DERIVED

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
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 22, 2005

First Posted

September 23, 2005

Study Start

March 1, 2004

Study Completion

September 1, 2006

Last Updated

April 23, 2010

Record last verified: 2010-04