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Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 5)

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ClinicalTrials.gov Identifier: NCT03240523
Recruitment Status : Active, not recruiting
First Posted : August 7, 2017
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

The primary objective of this study is to describe the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal.

The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids.


Condition or disease Intervention/treatment Phase
Uterine Fibroids Drug: Vilaprisan (BAY1002670) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: No new subjects will be randomized to group A3 and group B after implementation of Protocol version 5.0. All subjects originally assigned to those groups will receive open-label treatment with Vilaprisan only.New treatment group is called A3/B.
Primary Purpose: Treatment
Official Title: A Randomized, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : February 12, 2022
Estimated Study Completion Date : February 12, 2022

Arm Intervention/treatment
Experimental: Group A1: Vilaprisan (3/1 regimen)
Orally, 2 mg, once daily, 3 months treatment followed by 1 menstrual bleeding episode
Drug: Vilaprisan (BAY1002670)
Orally, 2 mg, once daily

Experimental: Group A2: Vilaprisan (6/2 regimen)
Orally, 2 mg, once daily, 6 months treatment followed by 2 menstrual bleeding episodes
Drug: Vilaprisan (BAY1002670)
Orally, 2 mg, once daily

Experimental: Group A3/B (3/2 regimen)

Orally, 2 mg, once daily, 3 months treatment followed by 2 menstrual bleeding episodes

No new subjects will be randomized to previous group A3 and group B after implementation of Protocol version 5.0. All subjects originally assigned to those groups will receive open-label treatment with Vilaprisan only. New treatment group is called A3/B.

Drug: Vilaprisan (BAY1002670)
Orally, 2 mg, once daily




Primary Outcome Measures :
  1. Amenorrhea (yes/no) [ Time Frame: At 3 months (at the end of treatment perid 1) ]

    Defined as menstrual blood loss (MBL) < 2 mL based on the menstrual pictogram (MP) during last 28 days.

    For the primary analysis of the primary variable, the amenorrhea rates after 12 weeks of treatment in Groups A1, A2 and A3 will be compared to the rate from Group B.

    The study will be continued after the date of primary completion. Study results will be updated once the study is completed, after LPLV.


  2. Amenorrhea (yes/no) [ Time Frame: At approximately 1 year (end of treatment perid 3, including treatment breaks) ]

Secondary Outcome Measures :
  1. Total volume of menstrual blood loss [ Time Frame: After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2 ]
    Assessed by menstrual pictogram (MP). Volume of menstrual blood loss will be normalized by 28 days.

  2. Number of bleeding days [ Time Frame: After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2 ]
    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 days.

  3. Amenorrhea (yes/no) [ Time Frame: At 6 months, at 12 months, at 15 months, at 18 months, at 21 months and at 24 months ]
    Defined as menstrual blood loss (MBL) < 2 mL based on the menstrual pictogram (MP) during last 28 days of the treatment period.

  4. Absence of bleeding (spotting allowed) [ Time Frame: Up to 24 months ]
    Absence of bleeding defined as no bleeding (spotting allowed) during the last 28 days of the treatment; based on the UF-DBD (Uterine Fibroid Daily Symptom Diary).

  5. Time to onset of controlled bleeding [ Time Frame: Quarterly up to 24 months ]
    Onset of controlled bleeding is defined by the first day, for which the menstrual blood loss (assessed by MP) for all subsequent 28-day periods up to the end of the treatment period is less than 80.00 mL.

  6. HMB (Heavy Menstrual Bleeding) responder rate [ Time Frame: By treatment period up to 24 months ]
    Percentage of subjects with blood loss < 80.00 mL per 28 days and 50% reduction compared to baseline [assessed by MP]

  7. Percent change in volume of largest fibroid compared to baseline [ Time Frame: At baseline, at 12 months and at 24 months ]
    Measured by MRI (magnetic resonance imaging).



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 at the time of Visit 1
  • Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm
  • Heavy menstrual bleeding (HMB) >80.00 mL documented by menstrual pictogram (MP) in a bleeding episode period during the screening period
  • Use of an acceptable non-hormonal method of contraception
  • An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology

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 drugs
  • Hemoglobin values ≤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values ≤10.9 g/dL will be recommended to use iron supplementation)
  • 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 including
  • Abuse of alcohol, drugs, or medicines (eg: laxatives)
  • Undiagnosed abnormal genital bleeding
  • Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results

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): NCT03240523


  Show 197 Study Locations
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: NCT03240523     History of Changes
Other Study ID Numbers: 15789
2016-002855-48 ( EudraCT Number )
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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