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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
Results First Posted : August 26, 2021
Last Update Posted : March 13, 2023
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care

Condition or disease Intervention/treatment Phase
Leiomyoma Drug: Vilaprisan (BAY1002670) Other: Standard of care Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 30, 2017
Actual Primary Completion Date : May 10, 2019
Estimated Study Completion Date : June 30, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: A1(3/1 regimen)
2.0 mg treatment of 12 weeks, each separated by 1 bleeding break
 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 12 weeks, 8 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen)
Experimental: A2(6/2 regimen)
2.0 mg treatment period of 24 weeks, each separated by 2 bleeding break
 Drug: Vilaprisan (BAY1002670)
2 mg of Vilaprisan once daily for 24 weeks, 2 treatment periods of 24 weeks, each separated by 2 bleeding episodes (6/2 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)
Experimental: A3(3/2 regimen)
2.0 mg treatment period of 12 weeks, each separated by 2 bleeding break
 Drug: Vilaprisan (BAY1002670)
2 mg of Vilaprisan once daily for 12 weeks, 4 treatment periods of 12 weeks, each separated by 2 bleeding episodes (3/2 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)
B(Standard of care)
Standard of care as determined by the investigators, this could be watch & wait or non-hormonal medical treatment
 Other: Standard of care
Standard of care as determined by the investigators (including watch and wait, symptomatic nonhormonal)


Outcome Measures
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Primary Outcome Measures :
  1. Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine [ Time Frame: From baseline to about 1 year after start of treatment ]
    The percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine from baseline to about one year after start of treatment (SoT) in all randomized and treated participants with measurements at those 2 time points in each treatment group.


Secondary Outcome Measures :
  1. Number of Bleeding Days [ Time Frame: Approximately 1 year ]
    Number of bleeding days were defined 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

  2. Endometrial Histology [ Time Frame: Approximately 1 year ]
    Number of participants with endometrial histology findings, e.g. benign endometrium, presence or absence of hyperplasia or malignancy

  3. Endometrial Thickness [ Time Frame: Treatment phase: appximately 1 year, follow-up phase: up to 2 years ]
    Ultrasound examinations were performed. Endometrial thickness was measured in the medio-sagittal section as double-layer in millimeters. Summary statistics for change from baseline in endometrial thickness was provided in below table.

  4. Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck [ Time Frame: Up to 2 years ]
    Percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine (other time points not mentioned as primary safety analysis), hip, and femoral neck from baseline was analyzed using the same statistical methods as used for the primary variable.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194646


Locations
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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
  Study Documents (Full-Text)

Documents provided by Bayer:
Study Protocol  [PDF] February 17, 2020
Statistical Analysis Plan  [PDF] March 4, 2021

More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03194646    
Other Study ID Numbers: 16953
2016-004822-41 ( EudraCT Number )
First Posted: June 21, 2017    Key Record Dates
Results First Posted: August 26, 2021
Last Update Posted: March 13, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Uterine Fibroid
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases