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Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 6)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03194646
Recruitment Status : Active, not recruiting
First Posted : June 21, 2017
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE June 20, 2017
First Posted Date  ICMJE June 21, 2017
Last Update Posted Date April 5, 2019
Actual Study Start Date  ICMJE June 30, 2017
Estimated Primary Completion Date September 13, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2017)
Percentage change in bone mineral density (BMD) of lumbar spine [ Time Frame: One year ]
The percentage change in BMD of lumbar spine from baseline to about one year after start of treatment (SoT) in all randomized and treated subjects with measurements at those 2 time points in each treatment group. The study will be continued after the date of primary completion. Study results will be updated once the study is completed, after LPLV.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03194646 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2018)
Number of bleeding days [ Time Frame: Approximately 1 year for subgroup 1 and approximately 2 years for subgroup 2 ]
Number of bleeding days from Day 1 of the first treatment period until the day before a new treatment period would start again following the last treatment period for that respective treatment group. Number to be normalized by 28 days
Original Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2017)
Number of bleeding days [ Time Frame: Approximately 1 year for subgroup 1 and approximately 2 years for subgroup 2 ]
The number of bleeding days from Day 1 of the first treatment period until the day before the next treatment period after the last treatment period would start again normalized to 28 day.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
Official Title  ICMJE An Open-label, Parallel-group, Randomized, Multicenter Study to Assess the Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Versus Standard of Care
Brief Summary The study is performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Leiomyoma
Intervention  ICMJE
  • Drug: Vilaprisan (BAY1002670)
    2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 1 bleeding episode(3/1 regimen).
  • Drug: Vilaprisan (BAY1002670)
    2 mg of Vilaprisan once daily for 24 weeks, 2 treatment periods of 24 weeks, each separated by 2 bleeding episodes episodes(6/2 regimen).
  • Drug: Vilaprisan (BAY1002670)
    2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 2 bleeding episodesepisodes(3/2 regimen).
  • Other: Standard of care
    Standard of care as determined by the investigators (including watch and wait, symptomatic nonhormonal)
  • Drug: Vilaprisan (BAY1002670)
    2 mg of Vilaprisan once daily for 12 weeks, 8 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen)
  • Drug: Vilaprisan (BAY1002670)
    2 mg of Vilaprisan once daily for 24 weeks, 4 treatment periods of 24 weeks, each separated by 2 bleeding episodes (6/2 regimen)
  • Drug: Vilaprisan (BAY1002670)
    2 mg of Vilaprisan once daily for 12 weeks, 6 treatment periods of 12 weeks, each separated by 2 bleeding episodes (3/2 regimen)
Study Arms  ICMJE
  • Experimental: A1(3/1 regimen)
    2.0 mg treatment of 12 weeks, each separated by 1 bleeding break
    Interventions:
    • Drug: Vilaprisan (BAY1002670)
    • Drug: Vilaprisan (BAY1002670)
  • Experimental: A2(6/2 regimen)
    2.0 mg treatment period of 24 weeks, each separated by 2 bleeding break
    Interventions:
    • Drug: Vilaprisan (BAY1002670)
    • Drug: Vilaprisan (BAY1002670)
  • Experimental: A3(3/2 regimen)
    2.0 mg treatment period of 12 weeks, each separated by 2 bleeding break
    Interventions:
    • Drug: Vilaprisan (BAY1002670)
    • Drug: Vilaprisan (BAY1002670)
  • B(Standard of care)
    Standard of care as determined by the investigators, this could be watch& wait or non-hormonal medical treatment
    Intervention: Other: Standard of care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 28, 2018)
1302
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2017)
1050
Estimated Study Completion Date  ICMJE September 13, 2021
Estimated Primary Completion Date September 13, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years or older
  • Diagnosis of uterine fibroid(s) documented by ultrasound at screening AND/OR during a uterine preserving procedure within 3 months prior to screening in subjects with high risk for recurrence
  • At least one symptom of uterine fibroid(s) - bleeding, pelvic pressure/pain
  • Good general health
  • Normal or clinically insignificant cervical smear
  • An endometrial biopsy performed during the screening period, without significant histological disorder
  • Use of an acceptable nonhormonal method of contraception starting at Visit 1 until the end of the study

Exclusion Criteria:

  • Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
  • Hypersensitivity to any ingredient of the study drug
  • Any condition requiring immediate blood transfusion
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Czechia,   Finland,   Hong Kong,   Japan,   Mexico,   Norway,   Poland,   Russian Federation,   South Africa,   Thailand,   Turkey,   United States
Removed Location Countries Colombia,   Spain
 
Administrative Information
NCT Number  ICMJE NCT03194646
Other Study ID Numbers  ICMJE 16953
2016-004822-41 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP