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

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ClinicalTrials.gov Identifier: NCT03400943
Recruitment Status : Active, not recruiting
First Posted : January 17, 2018
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

The primary objective of this study is to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.

The secondary objectives of this study are 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)
Estimated Enrollment : 260 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
Estimated Primary Completion Date : November 13, 2021
Estimated Study Completion Date : November 13, 2021

Arm Intervention/treatment
Experimental: Vilaprisan_A1
vilaprisan (2 mg), 2 treatment periods of 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 is administered to group B1 and B2.

Experimental: Vilaprisan_A2
vilaprisan (2 mg), 2 treatment periods of 12 weeks without a break
Drug: Vilaprisan (BAY1002670)
2 mg of Vilaprisan once daily up to 2 x 12 weeks

Experimental: Vilaprisan_B1
placebo, 1 treatment period of 12 weeks, and vilaprisan (2 mg), 1 treatment period of 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 is administered to group B1 and B2.

Experimental: Vilaprisan_B2
vilaprisan (2 mg), 1 treatment period of 12 weeks, and placebo, 1 treatment period of 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 is administered to group B1 and B2.




Primary Outcome Measures :
  1. Amenorrhea (yes/no) [ Time Frame: The last 28 days of treatment period 1 and treatment period 2 ]
    Amenorrhea (yes/no), defined as MBL <2 mL during the last 28 days of treatment


Secondary Outcome Measures :
  1. Heavy Menstrual Bleeding (HMB) response [ Time Frame: The last 28 days of treatment period 1 and treatment period 2 ]
    HMB response defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to 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 is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL

  3. Time to onset of controlled bleeding [ Time Frame: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks) ]
    HMB response defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline

  4. Absence of bleeding (spotting allowed) [ Time Frame: The last 28 days of treatment period 1 and treatment period 2 ]
    By 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 ]


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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


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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03400943     History of Changes
Other Study ID Numbers: 15787
2017-002997-38 ( EudraCT Number )
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019

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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