Efficacy and Safety of SH T00660AA in Treatment of Endometriosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of SH T00660AA in Treatment of Endometriosis

NCT00225186

Endometriosis

COMPLETED PHASE3

To Evaluate Effectiveness of Visanne in Improving Quality of Life in Asian Women With Endometriosis

NCT02425462

Endometriosis

COMPLETED

Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis

NCT03573336

Endometriosis

TERMINATED PHASE2

A Trial to Learn What Happens to Different Medicinal Forms of BAY2328065 When They Enter the Body and How Safe They Are in Healthy Male and Female Participants

NCT04851483

Endometriosis

COMPLETED PHASE1

Study on the Safety of the Drug BAY2395840 at Different Doses, the Way the Body Absorbs, Distributes and Excretes the Drug Including the Effect of Its Formulation (Tablet or Liquid) and the Effect of Food on the Absorption, Distribution or Excretion of the Drug in Healthy Male Participants

NCT05517746

Endometriosis

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometriosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Group Type EXPERIMENTAL

Visanne (BAY86-5258, SH T00660AA)

Intervention Type DRUG

orally once daily

Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

orally once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Visanne (BAY86-5258, SH T00660AA)

orally once daily

Intervention Type DRUG

Placebo

orally once daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Female patients with endometriosis-associated pelvic pain

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No