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Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)

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: NCT03400943
Recruitment Status : Completed
First Posted : January 17, 2018
Results First Posted : June 11, 2021
Last Update Posted : June 21, 2022
Sponsor:
Information provided by (Responsible Party):
Bayer

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.


Condition or disease Intervention/treatment Phase
Leiomyoma Drug: Vilaprisan (BAY1002670) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Blinding will be applied to Treatment Groups A1, B1, and B2; Treatment Group A2 will be open-label
Primary Purpose: Treatment
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
Actual Study Start Date : January 17, 2018
Actual Primary Completion Date : June 9, 2019
Actual Study Completion Date : April 6, 2022

Arm Intervention/treatment
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.
Drug: Vilaprisan (BAY1002670)
2 mg of Vilaprisan once daily up to 2 x 12 weeks

Drug: Placebo
Matching placebo was administered to group B1 and B2.

Experimental: Vilaprisan (A2)
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
Drug: Vilaprisan (BAY1002670)
2 mg of Vilaprisan once daily up to 2 x 12 weeks

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.
Drug: Vilaprisan (BAY1002670)
2 mg of Vilaprisan once daily up to 2 x 12 weeks

Drug: Placebo
Matching placebo was administered to group B1 and B2.

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.
Drug: Vilaprisan (BAY1002670)
2 mg of Vilaprisan once daily up to 2 x 12 weeks

Drug: Placebo
Matching placebo was administered to group B1 and B2.




Primary Outcome Measures :
  1. Number of Participants With Amenorrhea [ Time Frame: The last 28 days of treatment period 1 ]
    Amenorrhea was defined as menstrual blood loss (MBL) <2 mL during the last 28 days of treatment.


Secondary Outcome Measures :
  1. Number of Participants With Heavy Menstrual Bleeding (HMB) Response [ Time Frame: The last 28 days of treatment period 1 and treatment period 2 ]
    HMB response was defined as MBL <80 mL during the last 28 days of treatment and >50% reduction from baseline.

  2. Time to Onset of Amenorrhea [ Time Frame: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks) ]
    Onset of amenorrhea was defined by the first day for which the MBL for all subsequent 28-day periods up to the end of a treatment period was < 2 mL (amenorrhea defined similar to primary endpoint).

  3. Time to Onset of Controlled Bleeding [ Time Frame: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks) ]
    Onset of controlled bleeding was defined by the first day for which the MBL for all subsequent 28-day periods up to the end of a treatment period was <80.00 mL.

  4. Number of Participants With Absence of Bleeding (Spotting Allowed) [ Time Frame: The last 28 days of treatment period 1 and treatment period 2 ]
    Absence of bleeding was defined as no scheduled or unscheduled bleeding (spotting allowed) during the last 28 days of a treatment period based on subjects' daily responses to the Uterine Fibroid Daily Bleeding Diary (UF-DBD).

  5. Endometrial Histology [ Time Frame: Up to 36 weeks ]
    Benign endometrium, presence or absence of hyperplasia or malignancy

  6. Endometrial Thickness [ Time Frame: Up to 36 weeks ]


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:

  • 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

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): NCT03400943


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] May 20, 2020

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03400943    
Other Study ID Numbers: 15787
2017-002997-38 ( EudraCT Number )
First Posted: January 17, 2018    Key Record Dates
Results First Posted: June 11, 2021
Last Update Posted: June 21, 2022
Last Verified: June 2022

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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 fibroids
Heavy menstrual bleeding
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