A Study to Test Whether Study Drug BAY1128688 Brings Pain Relief to Women With Endometriosis and if so to Get a First Idea Which Dose(s) Work Best | NCT03373422 | Trialant

TerminatedInterventionalPhase 2Updated Oct 3, 2019

A Study to Test Whether Study Drug BAY1128688 Brings Pain Relief to Women With Endometriosis and if so to Get a First Idea Which Dose(s) Work Best

A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center, Exploratory Dose-response Study to Assess the Efficacy and Safety of Different Oral Doses of BAY1128688 in Women With Symptomatic Endometriosis Over a 12-week Treatment Period

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT03373422
Lead Sponsor: BayerINDUSTRY
Overall Status: Terminated
Study Type: Interventional
Phase: Phase 2
Enrollment: 121Actual
Last Update Posted: Oct 3, 2019Actual
Start Date: Nov 30, 2017Actual
Primary Completion Date: Jul 23, 2018Actual
Completion Date: Oct 22, 2018Actual

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center, Exploratory Dose-response Study to Assess the Efficacy and Safety of Different Oral Doses of BAY1128688 in Women With Symptomatic Endometriosis Over a 12-week Treatment Period
Brief Summary: Purpose of the study is to test whether study drug BAY1128688 brings relief for pain to women with endometriosis and if so to get a first impression which dose(s) work best.

Conditions

The medical conditions and diseases this study investigates.

Endometriosis

Interventions

The treatments and procedures being evaluated in this study.

BAY1128688
Placebo

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Women of at least 18 years of age at the time of signing of informed consent

Women with endometriosis confirmed by at least one of the two criteria:

surgery within the last 10 years

imaging within the last 12 months

moderate to severe pelvic pain which will be assessed over a period of 28 days

Willingness to use only ibuprofen as rescue pain medication for endometriosis-associated pelvic pain

Willingness to use non-hormonal barrier method for contraception (here spermicide-coated condoms) from screening visit until the end of the study (unless adequate contraception is achieved by vasectomy of the partner or use of copper intrauterine device [IUD] or commitment to abstinence) and refrain from using hormonal contraception

Exclusion Criteria:

Pregnancy or lactation (more than three months since delivery, abortion, or lactation before start of treatment) AND no wish for pregnancy during the study

Altered bilirubin metabolism and liver function at Visit 1

Requirement to use pain medications for reasons other than endometriosis

Contraindications to using ibuprofen

Signs of hyperandrogenism

Absence of menstrual cycles and/or abnormal vaginal/genital bleeding

History of hysterectomy, tubal-ligation or bilateral ovariectomy

Uncontrolled thyroid disorder

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Contacts

The people to reach with questions about this study or how to join it.

No central contacts

There are no central contacts for this study.

Locations

Where the study is run and whether each site is currently recruiting.

Medizinische Universität Graz

Graz, Styria 8036, Austria

Collaborators

The organizations and people involved in this study.

Lead Sponsor: BayerINDUSTRY

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