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

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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
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Charleston, South Carolina 29406
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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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...
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4110 Center Point Dr.
Fort Myers, Florida 33916
239-936-4421
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
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1000 W Carson St
Torrance, California 90502
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Albuquerque, New Mexico 87109
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207 South Santa Anita Street
Arcadia, California 91007
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Augusta, Georgia 30912
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Aventura, Florida 33180
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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2609 Woolbright Road
Boynton Beach, Florida 33436
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26781 Bouquet Canyon Road
Canyon Country, California 91351
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Charlotte, North Carolina 28207
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Chattanooga, Tennessee 37421
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10506 Montgomery Road
Cincinnati, Ohio 45242
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Clemmons, North Carolina 27103
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800 Talbotton Road
Columbus, Georgia 31904
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Columbus, Ohio 43213
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Columbus, Ohio 43213
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4700 State Road 7
Coral Springs, Florida 33065
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Durham, North Carolina 27713
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Fall River, Massachusetts 02721
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Fort Lauderdale, Florida 33316
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Fort Worth, Texas 76104
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Greensboro, North Carolina 27408
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Houston, Texas 77074
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Houston, Texas 77054
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Houston, Texas 77062
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Linz, Oberösterreich
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Longview, Texas 75605
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Los Angeles, California 90036
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Metairie, Louisiana 70001
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10555 West Flagler Street
Miami, Florida 33174
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611 North 35th Street
Morehead City, North Carolina 28557
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New Brunswick, New Jersey 08903
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
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Norfolk, Virginia 23502
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2725 Rebecca Lane
Orange City, Florida 32763
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Oviedo, Florida 32765
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Peachtree Corners, Georgia 30092
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Phoenix, Arizona 85032
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Raleigh, North Carolina 27607
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3100 Duraleigh Road
Raleigh, North Carolina 27612
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Saginaw, Michigan 48602
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Salt Lake City, Utah 84088
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Shawnee Mission, Kansas 66218
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Shreveport, Louisiana 71118
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101 East Wood Street
Spartanburg, South Carolina 29301
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1447 Ebenezer Road
Spartanburg, South Carolina 29303
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Stamford, Connecticut 06904
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1850 M Street Northwest
Washington, District of Columbia 20036
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Winston-Salem, North Carolina 27103
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