Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis



Status:Active, not recruiting
Conditions:Women's Studies, Endometriosis
Therapuetic Areas:Other, Reproductive
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:July 4, 2018
End Date:August 17, 2022

Use our guide to learn which trials are right for you!

A Randomized, Double-blind, Parallel-group, Multicenter Phase 2b Study to Assess the Efficacy and Safety of Two Different Doses of Vilaprisan (BAY1002670) Versus Placebo in Women With Symptomatic Endometriosis

The primary objective of this study is to assess the efficacy and safety of two doses of
vilaprisan compared to placebo in women with symptomatic endometriosis.

The secondary objective of this study is to evaluate the safety and tolerability of two
different doses of vilaprisan in women with symptomatic endometriosis.


Inclusion Criteria:

- Signed and dated informed consent

- Pre-menopausal women 18 years (inclusive) and above at the time of Visit 1

- Women with endometriosis confirmed by laparoscopy or laparotomy OR diagnosed based on
imaging

- Moderate to severe endometriosis-associated pelvic pain (EAPP)

- Adherence to screening period diary entries

- Willingness to use only standardized pain medication if needed

- Good general health (except for findings related to endometriosis)

- Normal or clinically insignificant cervical cytology not requiring further follow-up

- An endometrial biopsy performed at the screening phase without significant
histological disorder

- Use of an acceptable non-hormonal method of contraception

- Willingness / ability to comply with electronic diary entry for the duration of study
participation

Exclusion Criteria:

- Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation
before Visit 1)

- Hypersensitivity to any ingredient of the study treatments

- Laboratory values outside the inclusion range before randomization, and considered
clinically relevant

- Any diseases or conditions that can compromise the function of the body systems and
could result in altered absorption, excessive accumulation, impaired metabolism, or
altered excretion of the study drug including elevated liver enzymes

- Any diseases or conditions that might interfere with the conduct of the study or the
interpretation of the results

- Undiagnosed abnormal genital bleeding

- Abuse of alcohol, drugs, or medicines (e.g. laxatives) as evaluated by the
investigator

- Use of other treatments that might interfere with the conduct of the study or the
interpretation of the results

- Endometriosis-specific treatments for symptom relief except rescue pain medication
according to protocol

- Simultaneous participation in another clinical trial with investigational medicinal
product(s). Participation in another trial prior to study entry that might have an
impact on the study objectives, at the discretion of the investigator

- Inability to cooperate with the study procedures for any reason

- Previous assignment to treatment (e.g. randomization) during this study (allowing
previously randomized subjects to be re-included into the study may lead to bias)

- Hypersensitivity to any ingredient of standardized pain medication

- Wish for pregnancy during the study

- Regular use of pain medication due to other underlying diseases

- Non-responsiveness of EAPP to GnRH-a
We found this trial at
62
sites
Aventura, Florida 33180
?
mi
from
Aventura, FL
Click here to add this to my saved trials
860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
?
mi
from
DeLand, FL
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
4110 Center Point Dr.
Fort Myers, Florida 33916
239-936-4421
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
1000 W Carson St
Torrance, California 90502
?
mi
from
Torrance, CA
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
207 South Santa Anita Street
Arcadia, California 91007
?
mi
from
Arcadia, CA
Click here to add this to my saved trials
Augusta, Georgia 30912
?
mi
from
Augusta, GA
Click here to add this to my saved trials
733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
2609 Woolbright Road
Boynton Beach, Florida 33436
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
26781 Bouquet Canyon Road
Canyon Country, California 91351
?
mi
from
Canyon Country, CA
Click here to add this to my saved trials
Charleston, South Carolina 29406
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chattanooga, Tennessee 37421
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
10506 Montgomery Road
Cincinnati, Ohio 45242
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clemmons, North Carolina 27103
?
mi
from
Clemmons, NC
Click here to add this to my saved trials
800 Talbotton Road
Columbus, Georgia 31904
?
mi
from
Columbus, GA
Click here to add this to my saved trials
Columbus, Ohio 43213
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Columbus, Ohio 43213
?
mi
from
Columbus, OH
Click here to add this to my saved trials
4700 State Road 7
Coral Springs, Florida 33065
?
mi
from
Coral Springs, FL
Click here to add this to my saved trials
Durham, North Carolina 27713
?
mi
from
Durham, NC
Click here to add this to my saved trials
Fall River, Massachusetts 02721
?
mi
from
Fall River, MA
Click here to add this to my saved trials
Fort Lauderdale, Florida 33316
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Fort Worth, Texas 76104
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
?
mi
from
Frisco, TX
Click here to add this to my saved trials
Greensboro, North Carolina 27408
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
?
mi
from
Hershey, PA
Click here to add this to my saved trials
Houston, Texas 77074
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77054
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77062
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Linz, Oberösterreich
?
mi
from
Linz,
Click here to add this to my saved trials
Longview, Texas 75605
?
mi
from
Longview, TX
Click here to add this to my saved trials
Los Angeles, California 90036
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Metairie, Louisiana 70001
?
mi
from
Metairie, LA
Click here to add this to my saved trials
10555 West Flagler Street
Miami, Florida 33174
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
611 North 35th Street
Morehead City, North Carolina 28557
?
mi
from
Morehead City, NC
Click here to add this to my saved trials
New Brunswick, New Jersey 08903
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
Norfolk, Virginia 23502
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
2725 Rebecca Lane
Orange City, Florida 32763
?
mi
from
Orange City, FL
Click here to add this to my saved trials
Orlando, Florida 32808
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Oviedo, Florida 32765
?
mi
from
Oviedo, FL
Click here to add this to my saved trials
Park Ridge, Illinois 60068
?
mi
from
Park Ridge, IL
Click here to add this to my saved trials
Peachtree Corners, Georgia 30092
?
mi
from
Peachtree Corners, GA
Click here to add this to my saved trials
Phoenix, Arizona 85032
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Raleigh, North Carolina 27607
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
3100 Duraleigh Road
Raleigh, North Carolina 27612
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
200 South Wenona Street
Saginaw, Michigan 48602
?
mi
from
Saginaw, MI
Click here to add this to my saved trials
Salt Lake City, Utah 84088
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Diego, California 92108
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Shawnee Mission, Kansas 66218
?
mi
from
Shawnee Mission, KS
Click here to add this to my saved trials
Shreveport, Louisiana 71118
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
101 East Wood Street
Spartanburg, South Carolina 29301
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
1447 Ebenezer Road
Spartanburg, South Carolina 29303
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
Stamford, Connecticut 06904
?
mi
from
Stamford, CT
Click here to add this to my saved trials
1850 M Street Northwest
Washington, District of Columbia 20036
?
mi
from
Washington,
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials