Clinical trial NCT03400943: Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)
Official title: A Randomized, Parallel-group, Double-blind and Open-label Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Uterine Fibroids
Keywords: Heavy menstrual bleeding
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-01-17
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.

The secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.


Eligibility criteria: Inclusion Criteria:

* Women, 18 years or older in good General health
* Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest Diameter ≥ 30 mm and \< 120 mm
* Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the Screening period each with blood loss volume of \>80.00 mL documented by alkaline hematin (AH) method
* An endometrial biopsy performed during the Screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology
* Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study

Exclusion Criteria:

* Pregnancy or lactation (less than 3 month since delivery, abortion, or lactation before start of Treatment)
* Hypersensitivity to any ingredient of the study drug
* Any condition requiring immediate blood transfusion
* Laboratory values outside inclusion range before randomization and considered as clinically relevant.
* Any diseases, conditions, or medications 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
* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
* Abuse of alcohol, drugs, or medicines (eg, laxatives)
* Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
* Undiagnosed abnormal genital bleeding

Primary outcomes:
measure: Number of Participants With Amenorrhea
timeFrame: The last 28 days of treatment period 1
Secondary outcomes:
measure: Number of Participants With Heavy Menstrual Bleeding (HMB) Response
timeFrame: The last 28 days of treatment period 1 and treatment period 2
measure: Time to Onset of Amenorrhea
timeFrame: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
measure: Time to Onset of Controlled Bleeding
timeFrame: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
measure: Number of Participants With Absence of Bleeding (Spotting Allowed)
timeFrame: The last 28 days of treatment period 1 and treatment period 2
measure: Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
timeFrame: Up to 2 weeks after end of treatment
measure: Change From Baseline of Endometrial Thickness
timeFrame: Treatment phase (up to 2 weeks after end of treatment) and follow-up phase (starts on the day after the end of the treatment until the last study visit [up to approximately 2 years])
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Arcadia
country: United States
facility: California Center for Clinical Research
state: California
city: Cerritos
country: United States
facility: Core Healthcare Group
state: California
city: Escondido
country: United States
facility: AVIVA Research
state: California
city: Los Angeles
country: United States
facility: National Research Institute - Los Angeles
state: California
city: Torrance
country: United States
facility: Harbor - UCLA Medical Center
state: California
city: Aventura
country: United States
facility: Ideal Clinical Research
state: Florida
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Boynton Beach
country: United States
facility: Helix Biomedics, LLC
state: Florida
city: Doral
country: United States
facility: Dr. Victoria Garcia & Associates, LLC Doral Medical Research
state: Florida
city: Hialeah
country: United States
facility: Sweet Hope Research Specialty, Inc. - Hialeah
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare
state: Florida
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Loxahatchee Groves
country: United States
facility: Axcess Medical Research, LLC
state: Florida
city: Miami Springs
country: United States
facility: Ocean Blue Medical Research Center, Inc.
state: Florida
city: Orlando
country: United States
facility: Accelerated Enrollment Solutions a business of PPD
state: Florida
city: Plantation
country: United States
facility: Discovery Clinical Research
state: Florida
city: Saint Cloud
country: United States
facility: ONCOVA Clinical Research, Inc.
state: Florida
city: Atlanta
country: United States
facility: Georgia Center For Women
state: Georgia
city: Atlanta
country: United States
facility: Agile Clinical Research Trials, LLC
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Women's Research Institute, Inc. - Alpharetta
state: Georgia
city: Atlanta
country: United States
facility: Medisense, Inc.
state: Georgia
city: College Park
country: United States
facility: Paramount Research Solutions-College Park
state: Georgia
city: Norcross
country: United States
facility: One Health Research Clinic
state: Georgia
city: Savannah
country: United States
facility: Fellows Research Alliance - Savannah
state: Georgia
city: Shawnee Mission
country: United States
facility: GTC Research
state: Kansas
city: Shreveport
country: United States
facility: Omni Fertility and Laser Institute
state: Louisiana
city: Baltimore
country: United States
facility: PharmaSite Research, Inc.
state: Maryland
city: Gaithersburg
country: United States
facility: Simmonds, Martin and Helmbrecht
state: Maryland
city: Silver Spring
country: United States
facility: Advantia Health, LLC Obstetrics & Gynecology Assoc.
state: Maryland
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Healthcare System
state: North Carolina
city: Morehead City
country: United States
facility: Unified Women's Clinical Research - Morehead City
state: North Carolina
city: New Bern
country: United States
facility: Eastern Carolina Women's Center
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research, Inc.
state: North Carolina
city: Bryn Mawr
country: United States
facility: Main Line Fertility Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC
state: Pennsylvania
city: Bluffton
country: United States
facility: Fellows Research Alliance, Inc.
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Spartanburg
country: United States
facility: Fusion Clinical Research of Spartanburg, LLC
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research, LLC
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neurosciences Solutions, Inc DBA CNS Healthcare
state: Tennessee
city: Nashville
country: United States
facility: Paramount Research Solutions-Nashville
state: Tennessee
city: Fort Worth
country: United States
facility: Texas Health Care, PLLC
state: Texas
city: Frisco
country: United States
facility: Willowbend Health & Wellness Associates
state: Texas
city: Georgetown
country: United States
facility: Family Medicine Clinic
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, Inc.
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc.
state: Texas
city: Houston
country: United States
facility: The Center for Clinical Trials, Inc.
state: Texas
city: Sugar Land
country: United States
facility: Houston Center for Clinical Research, LLC
state: Texas
city: Arlington
country: United States
facility: Millennium Clinical Trials, LLC
state: Virginia
city: Richmond
country: United States
facility: Synexus Research, LLC
state: Virginia
city: Gabrovo
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment-Dr. T. Venkova AD
city: Lovech
country: Bulgaria
facility: Hospital for Active Treatment - Prof.Paraskev Stoyanov AD
city: Smolyan
country: Bulgaria
facility: MHAT Dr. Bratan Shukerov AD
city: Sofia
country: Bulgaria
facility: MHAT for Women's Health - Nadezhda OOD
city: Fuzhou
country: China
facility: 900th Hospital of Joint Logistics Support Force
state: Fujian
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Zhongshan
country: China
facility: Boai Hospital of Zhongshan
state: Guangdong
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Wuhan
country: China
facility: Wuhan Tongji Reproductive Medicine Hospital
state: Hubei
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital
state: Jiangsu
city: Nanjing
country: China
facility: NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Suzhou
country: China
facility: 1st Affiliated hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Maternal and Child Health Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Xi'an
country: China
facility: Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Taiyuan
country: China
facility: The Second Affiliated Hospital of Shanxi Medical University
state: Shanxi
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: Women's Hospital School of Medicine Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Med
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affliated Hospital of Wenzhou Medicial University
state: Zhejiang
city: Beijing
country: China
facility: Beijing Hospital of Traditional Chinese Medicine
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Captial Medical University
city: Shanghai
country: China
facility: Shanghai East Hospital Affiated to Tongji University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Brno
country: Czechia
facility: Gynekologie MEDA s.r.o.
city: Fulnek
country: Czechia
facility: Soukroma gynekologicka ambulance
city: Praha 6
country: Czechia
facility: Gynekologie Studentsky dum s.r.o.
city: Vysoke Myto
country: Czechia
facility: MUDr. Ivana Salamonova s.r.o.
city: Afula
country: Israel
facility: Clalit Health Services through HaEmek Medical Center
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Kuala Lumpur
country: Malaysia
facility: University Hospital Kebangsaan Malaysia
city: Sabah
country: Malaysia
facility: Hospital Wanita dan Kanak-Kanak Sabah
city: Sarawak
country: Malaysia
facility: Sarawak General Hospital
city: Hawkes Bay
country: New Zealand
facility: P3 Research Ltd Hawkes Bay
city: Tauranga
country: New Zealand
facility: P3 Research
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
city: Lyttelton Manor
country: South Africa
facility: Dr L Reynders Practice
state: Gauteng
city: Roodepoort
country: South Africa
facility: Wilgeheuwel Hospital
state: Gauteng
city: Durban
country: South Africa
facility: Umhlanga Medical Centre
state: Kwazulu-Natal
city: Durban
country: South Africa
facility: Ethekwini Hospital & Heart Centre
state: Kwazulu-Natal
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: