Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
The study is 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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1302 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
Estimated Primary Completion Date : September 13, 2021
Estimated Study Completion Date : September 13, 2021

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 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 episodesepisodes(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)




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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


  Show 224 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Layout table for investigator information
Study Director: Bayer Study Director Bayer

Additional Information:
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03194646     History of Changes
Other Study ID Numbers: 16953
2016-004822-41 ( EudraCT Number )
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019

Layout table for additional information
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:
Layout table for MeSH terms
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases