Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids (ASTEROID 2)

November 21, 2016 updated by: Bayer

A Randomized, Parallel-group, Double-blind Placebo-controlled and Open Label Active Controlled, Multi-center Study to Assess the Efficacy and Safety of Vilaprisan in Patients With Uterine Fibroids

The study is performed to assess the efficacy of Vilaprisan (BAY1002670) in patients with uterine fibroids compared to placebo and ulipristal. It is also aimed to evaluate the safety of vilaprisan in subjects with uterine fibroids. Further, data on population pharmacokinetic (PK)/ pharmacodynamic (PD) relationship for vilaprisan in subjects with uterine fibroids will be supplemented.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1090
    • Kärnten
      • Villach, Kärnten, Austria, 9500
    • Steiermark
      • Graz, Steiermark, Austria, 8036
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
  • Belgium
      • Bruxelles - Brussel, Belgium, 1000
      • Edegem, Belgium, 2650
    • Vlaams Brabant
      • Tienen, Vlaams Brabant, Belgium, 3300
  • Bulgaria
      • Pleven, Bulgaria, 5800
      • Sofia, Bulgaria, 1606
      • Sofia, Bulgaria, 1504
      • Stara Zagora, Bulgaria, 6000
  • Czech Republic
      • Brno, Czech Republic, 625 00
      • Ceske Budejovice, Czech Republic, 37001
      • Olomouc, Czech Republic, 775 20
      • Olomouc, Czech Republic, 772 00
      • Pisek, Czech Republic, 39701
      • Plzen, Czech Republic, 30708
      • Praha, Czech Republic, 13000
      • Praha 2, Czech Republic, 120 00
      • Praha 8, Czech Republic, 180 81
  • Finland
      • Helsinki, Finland, 00610
      • Pori, Finland, 28500
      • Turku, Finland, 20100
  • Germany
      • Berlin, Germany, 10787
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
    • Sachsen-Anhalt
      • Bernburg, Sachsen-Anhalt, Germany, 06406
      • Blankenburg, Sachsen-Anhalt, Germany, 38889
  • Hungary
      • Budapest, Hungary, 1036
      • Debrecen, Hungary, 4032
      • Debrecen, Hungary, 4024
      • Szentes, Hungary, H-6600
  • Italy
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41124
    • Sardegna
      • Cagliari, Sardegna, Italy, 09042
    • Sicilia
      • Catania, Sicilia, Italy, 95123
  • Lithuania
      • Vilnius, Lithuania, LT-10207
      • Vilnius, Lithuania, LT-05263
      • Vilnius, Lithuania, LT-08217
  • Netherlands
      • Almere, Netherlands, 1315 RA
      • Heerlen, Netherlands, 6419 PC
      • Nieuwegein, Netherlands, 3435 CM
      • Zwolle, Netherlands, 8025 AB
  • Norway
      • Fredrikstad, Norway, 1605
      • Lørenskog, Norway, 1478
      • Nesttun, Norway, 5221
      • Stavanger, Norway, 4011
  • Poland
      • Bialystok, Poland, 15- 224
      • Lodz, Poland, 90-602
      • Lublin, Poland, 20-093
      • Lublin, Poland, 20-632
      • Warszawa, Poland, 02-507
  • Portugal
      • Coimbra, Portugal, 3000-075
      • Lisboa, Portugal, 1449-005
      • Porto, Portugal, 4202-451
  • Spain
      • Barcelona, Spain, 08003
      • Valencia, Spain, 46026
      • Valencia, Spain, 46010
    • Madrid
      • Aravaca, Madrid, Spain, 28023
  • Sweden
      • Stockholm, Sweden, 171 76
      • Stockholm, Sweden, 118 83
      • Umeå, Sweden, 90185
  • United Kingdom
      • London, United Kingdom, N19 5NF
      • Nottingham, United Kingdom, NG7 2UH
      • Portsmouth, United Kingdom, PO6 3LY
    • London
      • Harrow, London, United Kingdom, HA1 3UJ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women, 18 to 50 years of age at the time of screening
  • Diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter >/=3.0 cm
  • Heavy menstrual bleeding (HMB) >80 mL documented by menstrual pictogram (MP) in a bleeding episode during the screening period. Women who did not suffer from perceived HMB during the 3 months prior to Visit 1 due to any effective medical treatment, e.g. with a hormonal contraceptive, are not considered appropriate candidates and should not undergo further screening procedures. Women suffering from perceived HMB despite medical treatment, e.g. with a hormonal contraceptive, are appropriate candidates for further screening, if rules on stopping prior medication are followed. Heavy menstrual bleeding /HMB) > 80 mL should be documented within 10 consecutive days.
  • Good general health (except for findings related to uterine fibroids) as proven by medical history, physical and gynecological examinations, and laboratory test results
  • Normal or clinically insignificant cervical smear not requiring further follow-up. Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASCUS) can be used as an adjunctive test. Subjects with ASCUS can be included if they are negative for high-risk HPV strains.
  • 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 nonhormonal method of contraception (i.e. either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at the bleeding episode following the screening visit 1 (Visit 1) until the end of the study. This is not required if safe contraception is achieved by a permanent method, such as bilateral fallopian tube blockage of the subject or vasectomy of the partner(s).

Exclusion Criteria:

  • Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
  • Uterine fibroid with largest diameter >10.0 cm
  • 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 offered iron supplementation).
  • Any diseases or conditions 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 (e.g. laxatives)
  • Use of other treatments that might interfere with the conduct of the study or the interpretation of the results
  • Undiagnosed abnormal genital bleeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1 - BAY1002670 + BAY1002670
Vilaprisan (BAY1002670) 2 mg once daily (12 weeks), Vilaprisan 2 mg once daily (12 weeks)
Drug: Vilaprisan (BAY1002670)
Vilaprisan 2 mg (12 weeks), Vilaprisan 2 mg (12 weeks)
Drug: Vilaprisan (BAY1002670)
Placebo (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)
Experimental: Arm 2 - Placebo + BAY1002670
Placebo once daily (12 weeks), Vilaprisan 2 mg once daily (12 weeks)
Drug: Vilaprisan (BAY1002670
Placebo (12 weeks),Vilaprisan (12 weeks)
Drug: Vilaprisan (BAY1002670
Vilaprisan 2 mg (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)
Experimental: Arm 3 - BAY1002670 + BAY1002670
Vilaprisan 2 mg once daily (12 weeks), treatment break, Vilaprisan 2 mg once daily (12 weeks)
Drug: Vilaprisan (BAY1002670
Placebo (12 weeks),Vilaprisan (12 weeks)
Drug: Vilaprisan (BAY1002670
Vilaprisan 2 mg (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)
Experimental: Arm 4 - Placebo+BAY1002670
Placebo once daily (12 weeks), treatment break, Vilaprisan 2 mg once daily(12 weeks)
Drug: Vilaprisan (BAY1002670)
Vilaprisan 2 mg (12 weeks), Vilaprisan 2 mg (12 weeks)
Drug: Vilaprisan (BAY1002670)
Placebo (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)
Active Comparator: Arm 5 - Ulipristal + Ulipristal
Ulipristal 5 mg once daily (12 weeks), treatment break, Ulipristal 5 mg once daily (12 weeks)
Drug: Ulipristal
Ulipristal 5 mg (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)
Drug: Ulipristal
Placebo (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)
Drug: Ulipristal
Ulipristal (12 weeks), treatment break, Placebo (12 weeks)
Active Comparator: Arm 6- Placebo + Ulipristal
Placebo once daily (12 weeks), treatment break, Ulipristal 5 mg once daily (12 weeks)
Drug: Ulipristal
Ulipristal 5 mg (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)
Drug: Ulipristal
Placebo (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)
Drug: Ulipristal
Ulipristal (12 weeks), treatment break, Placebo (12 weeks)
Active Comparator: Arm 7- Ulipristal + Placebo
Ulipristal 5 mg once daily (12 weeks), treatment break, Placebo once daily (12 weeks)
Drug: Ulipristal
Ulipristal 5 mg (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)
Drug: Ulipristal
Placebo (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)
Drug: Ulipristal
Ulipristal (12 weeks), treatment break, Placebo (12 weeks)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Amenorrhea (yes/no)
Time Frame: From day 7 to day 84 of treatment.
Defined as no scheduled or unscheduled bleeding/spotting after end of the initial bleeding episode until the end of the respective treatment period.
From day 7 to day 84 of treatment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of bleeding days
Time Frame: Up to 32 weeks
Up to 32 weeks
Time to onset of controlled bleeding
Time Frame: Up to 28 weeks
Up to 28 weeks
Percent change in volume of largest fibroid from baseline to end of treatment.
Time Frame: Baseline and up to 28 weeks
Baseline and up to 28 weeks
Endometrial histology
Time Frame: Baseline and up to 40 weeks
(Frequency of the following categories: benign endometrium, endometrial hyperplasia, malignant neoplasm)
Baseline and up to 40 weeks
Endometrial thickness measured by transvaginal ultrasound.
Time Frame: Baseline and up to 40 weeks
Baseline and up to 40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17541
  • 2014-004221-41 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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