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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03400943




Registration number
NCT03400943
Ethics application status
Date submitted
5/01/2018
Date registered
17/01/2018

Titles & IDs
Public title
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)
Scientific 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
Secondary ID [1] 0 0
2017-002997-38
Secondary ID [2] 0 0
15787
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uterine Fibroids 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vilaprisan (BAY1002670)
Treatment: Drugs - Placebo

Experimental: Vilaprisan (A1) - Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.

Experimental: Vilaprisan (A2) - Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.

Experimental: Placebo+Vilaprisan (B1) - Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.

Experimental: Vilaprisan+Placebo (B2) - Vilaprisan (2 mg) in treatment period 1 for 12 weeks and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.


Treatment: Drugs: Vilaprisan (BAY1002670)
2 mg of Vilaprisan once daily up to 2 x 12 weeks

Treatment: Drugs: Placebo
Matching placebo was administered to group B1 and B2.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Amenorrhea
Timepoint [1] 0 0
The last 28 days of treatment period 1
Secondary outcome [1] 0 0
Number of Participants With Heavy Menstrual Bleeding (HMB) Response
Timepoint [1] 0 0
The last 28 days of treatment period 1 and treatment period 2
Secondary outcome [2] 0 0
Time to Onset of Amenorrhea
Timepoint [2] 0 0
In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
Secondary outcome [3] 0 0
Time to Onset of Controlled Bleeding
Timepoint [3] 0 0
In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
Secondary outcome [4] 0 0
Number of Participants With Absence of Bleeding (Spotting Allowed)
Timepoint [4] 0 0
The last 28 days of treatment period 1 and treatment period 2
Secondary outcome [5] 0 0
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Timepoint [5] 0 0
Up to 2 weeks after end of treatment
Secondary outcome [6] 0 0
Change From Baseline of Endometrial Thickness
Timepoint [6] 0 0
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])

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/04/2022
Sample size
Target
Accrual to date
Final
93
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Gabrovo
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Lovech
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Smolyan
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Sofia
Country [19] 0 0
China
State/province [19] 0 0
Fujian
Country [20] 0 0
China
State/province [20] 0 0
Guangdong
Country [21] 0 0
China
State/province [21] 0 0
Hainan
Country [22] 0 0
China
State/province [22] 0 0
Hubei
Country [23] 0 0
China
State/province [23] 0 0
Jiangsu
Country [24] 0 0
China
State/province [24] 0 0
Jiangxi
Country [25] 0 0
China
State/province [25] 0 0
Jilin
Country [26] 0 0
China
State/province [26] 0 0
Liaoning
Country [27] 0 0
China
State/province [27] 0 0
Ningxia
Country [28] 0 0
China
State/province [28] 0 0
Shaanxi
Country [29] 0 0
China
State/province [29] 0 0
Shanxi
Country [30] 0 0
China
State/province [30] 0 0
Xinjiang
Country [31] 0 0
China
State/province [31] 0 0
Zhejiang
Country [32] 0 0
China
State/province [32] 0 0
Beijing
Country [33] 0 0
China
State/province [33] 0 0
Shanghai
Country [34] 0 0
China
State/province [34] 0 0
Tianjin
Country [35] 0 0
Czechia
State/province [35] 0 0
Brno
Country [36] 0 0
Czechia
State/province [36] 0 0
Fulnek
Country [37] 0 0
Czechia
State/province [37] 0 0
Praha 6
Country [38] 0 0
Czechia
State/province [38] 0 0
Vysoke Myto
Country [39] 0 0
Israel
State/province [39] 0 0
Afula
Country [40] 0 0
Israel
State/province [40] 0 0
Hadera
Country [41] 0 0
Israel
State/province [41] 0 0
Haifa
Country [42] 0 0
Israel
State/province [42] 0 0
Kfar Saba
Country [43] 0 0
Malaysia
State/province [43] 0 0
Kuala Lumpur
Country [44] 0 0
Malaysia
State/province [44] 0 0
Sabah
Country [45] 0 0
Malaysia
State/province [45] 0 0
Sarawak
Country [46] 0 0
New Zealand
State/province [46] 0 0
Hawkes Bay
Country [47] 0 0
New Zealand
State/province [47] 0 0
Tauranga
Country [48] 0 0
Singapore
State/province [48] 0 0
Singapore
Country [49] 0 0
South Africa
State/province [49] 0 0
Gauteng
Country [50] 0 0
South Africa
State/province [50] 0 0
Kwazulu-Natal

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03400943