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Uterine FibroidsPhase 3NCT03400956

Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)

A Phase 3 study testing Vilaprisan (BAY1002670) in people with Uterine Fibroids, run by Bayer at 87 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective of this study was to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) 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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Uterine Fibroids
What is being tested?
Vilaprisan (BAY1002670)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
103 participants
Where
87 sitesin 5 countries
Study dates
24 Jan 2018to 30 Jun 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 more than 30 mm and less than 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 the 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

Who cannot join

  • Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
  • Hypersensitivity to any ingredient of the study drug
  • 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
  • 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 results
  • Undiagnosed abnormal genital bleeding

Trial locations and contacts

87 sites in 5 countries.

87 sites in 5 countries

United States46 sites

  • Women Partners in Health Obstetrics & Gynecology (OB/GYN)

    Austin, Texas, 78705

  • Gadolin Research

    Beaumont, Texas, 77702

  • Clearview Medical Research, LLC

    Canyon Country, California, 91351

  • Women's Medical Research Group, LLC

    Clearwater, Florida, 33759

  • Vista Clinical Research

    Columbia, South Carolina, 29201

  • Discovery Clinical Trials

    Dallas, Texas, 75231

  • Diagnamics, Inc.

    Encinitas, California, 92024

  • New England Center for Clinical Research, Inc.

    Fall River, Massachusetts, 02720

  • Unified Women's Clinical Research

    Greensboro, North Carolina, 27408

  • Vital Pharma Research

    Hialeah, Florida, 33016

  • Chattanooga Women for Women

    Hixson, Tennessee, 37343

  • Advances in Health, Inc.

    Houston, Texas, 77030

  • National Research Institute

    Huntington Park, California, 90255

  • Women's Healthcare Associates, PA

    Idaho Falls, Idaho, 83404

  • Solutions Through Advanced Research, Inc.

    Jacksonville, Florida, 32256

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

  • Health Awareness, Inc.

    Jupiter, Florida, 33458

  • Grossmont Center for Clinical Research

    La Mesa, California, 91942

  • West Coast OB/GYN Associates

    La Mesa, California, 91942

  • Altea Research Institute

    Las Vegas, Nevada, 89102

  • South Florida Clinical Research Institute

    Margate, Florida, 33073

  • Suncoast Research Group, LLC

    Miami, Florida, 33135

  • Advanced Pharma CR, LLC

    Miami, Florida, 33147

  • Genoma Research Group, Inc.

    Miami, Florida, 33165

  • Florida Research Center, Inc.

    Miami, Florida, 33174

  • Miami Dade Medical Research Institute, LLC

    Miami, Florida, 33176

  • Vista Health Research

    Miami, Florida, 33176

  • Palmetto Professional Research

    Miami, Florida, 33186

  • Savin Medical Group LLC

    Miami Lakes, Florida, 33014

  • Tidewater Physicians for Women

    Norfolk, Virginia, 23502

  • A Premier Medical Research of Florida, LLC

    Orange City, Florida, 32763

  • Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare

    Orlando, Florida, 32801

  • Oviedo Medical Research, LLC

    Oviedo, Florida, 32765

  • National Research Institute

    Panorama City, California, 91402

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • DMI Research

    Pinellas Park, Florida, 33782

  • Oregon Health and Science University

    Portland, Oregon, 97239-3011

  • Discovery Clinical Trials

    San Antonio, Texas, 78258

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Medical Center for Clinical Research

    San Diego, California, 92108

  • Physician Care Clinical Research

    Sarasota, Florida, 34239

  • Seattle Clinical Research Center

    Seattle, Washington, 98105

  • Journey Medical Research

    Snellville, Georgia, 30078

  • Center of Reproductive Medicine

    Webster, Texas, 77598

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

  • Unified Women's Clinical Research / Ocala, FL

    Winston-Salem, North Carolina, 27103

Other trials in United States

Japan26 sites

  • Shonan Fujisawa Tokushukai Hospital

    Fujisawa, Kanagawa, 251-0041

  • Saiseikai Fukuoka General Hospital

    Fukuoka, 810-0001

  • Funabashi Municipal Medical Center

    Funabashi, Chiba, 273-8588

  • Unoki Clinic

    Kagoshima, 892-0826

  • Tetsu-Nakamura Obstetrics and Gynecology Internal Medicine

    Kagoshima, 892-0845

  • Kosumo Clinic

    Kako-gun, Hyōgo, 675-1115

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa, Chiba, 277-0871

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • Four Seasons Ladies' Clinic

    Kumamoto, 860-0846

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, 861-8520

  • Omi Medical Center

    Kusatsu, Shiga, 525-8585

  • Ijinkai Takeda General Hospital

    Kyoto, 601-1495

  • Japanese Red Cross Kyoto Daini Hospital

    Kyoto, 602-8026

  • Matsudo City General Hospital

    Matsudo, Chiba, 270-2296

  • Kyoto city Hospital

    Nakagyo-ku, Kyoto, 604-8845

  • Gokeikai Osaka Kaisei Hospital

    Osaka, 532-0003

  • Osaka City Hospital Organization Osaka City General Hospital

    Osaka, 534-0021

  • Medical Co. LEADING GIRLS Women's Clinic LUNA Shinsaibashi

    Osaka, 542-0086

  • Hashimoto Clinic

    Sapporo, Hokkaido, 004-0052

  • Ena Odori Clinic

    Sapporo, Hokkaido, 060-0001

  • Tokeidai Memorial Clinic

    Sapporo, Hokkaido, 060-0031

  • Yoshio Clinic

    Sapporo, Hokkaido, 064-0808

  • Medical Topia Soka Hospital

    Sōka, Saitama, 340-0028

  • Takamatsu Red Cross Hospital

    Takamatsu, Kagawa-ken, 760-0017

  • Asahi-Clinic.

    Takamatsu, Kagawa-ken, 760-0076

  • Kagawa Prefectural Central Hospital

    Takamatsu, Kagawa-ken, 760-8557

Other trials in Japan

Russia7 sites

  • Altai State Medical University

    Barnaul, 656038

  • Maternity Hospital, 17

    Saint Petersburg, 192174

  • Med Estetic Center

    Saint Petersburg, 192177

  • "Granti-Med"

    Saint Petersburg, 198329

  • Scien. Res. Institute of Obsterics, Gyn. & Reproduction

    Saint Petersburg, 199034

  • Close Joint Stock Company "Medical Company IDK"

    Samara, 443067

  • Smolensk State Medical University

    Smolensk, 214019

Other trials in Russia

Czechia5 sites

  • GynPorCentrum s.r.o.

    Krnov, 794 01

  • Gynekologie MUDr. Jaromir Karban s.r.o

    Neratovice, 277 11

  • Privatni gynekologicko-porodnicka ordinace

    Prague, 16000

  • GYNEVI s.r.o.

    Rokycany, 337 01

  • Gynekologicka ambulance - Zabreh na Morave

    Zábřeh, 78901

Other trials in Czechia

Ukraine3 sites

  • Chernivtsi Regional Perinatal Center

    Chernivtsi, 58001

  • Vinnytsia City Clinical Maternity Hospital No 2

    Vinnytsia, 21001

  • Zaporizhzhia Regional Clinical Hospital

    Zaporizhzhya, 69103

Other trials in Ukraine

About this study

Official title: A Randomized, Parallel-group, Double-blind and Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids

The primary objective of this study was to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) 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

Being tested
Vilaprisan (BAY1002670), Placebo
Keywords
Heavy menstrual bleeding
Medical subject headings
Leiomyoma, Menorrhagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vilaprisan (BAY1002670)Drug

    Orally, coated tablet 2 mg, once daily

  • PlaceboDrug

    Orally, coated tablet, once daily

Study groups in NCT03400956
Study groupRoleWhat they receive
Vilaprisan (A1)ExperimentalVilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Receives: Drug: Vilaprisan (BAY1002670)
Placebo+Vilaprisan (B1)ExperimentalPlacebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Receives: Drug: Vilaprisan (BAY1002670); Drug: Placebo
Vilaprisan+Placebo (B2)ExperimentalVilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Receives: Drug: Vilaprisan (BAY1002670); Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Amenorrhea

    Amenorrhea was defined as menstrual blood loss (MBL) < 2 mL during the last 28 days of treatment. The evaluation of MBL was based on the Alkaline hematin (AH) method.

    Measured: The last 28 days of treatment period 1

Secondary outcomes (6)

  1. Number of Participants With Heavy Menstrual Bleeding (HMB) Response

    HMB was defined as MBL <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline (assessed by the AH method).

    Measured: The last 28 days of treatment period 1 and treatment period 2

  2. Time to Onset of Amenorrhea

    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 and assessed by the AH method).

    Measured: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)

  3. Time to Onset of Controlled Bleeding

    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 (assessed by the AH method).

    Measured: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)

  4. Number of Participants With Absence of Bleeding (Spotting Allowed)

    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 UF-DBD (Uterine Fibroid Daily Bleeding Diary).

    Measured: The last 28 days of treatment period 1 and treatment period 2

  5. Number of Participants by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)

    Number of participants with endometrial histology findings, e.g. benign endometrium, malignant neoplasm, hyperplasia without atypia, hyperplasia with atypia and endometrial polyps.

    Measured: Up to 36 weeks

  6. Change From Baseline of Endometrial Thickness

    Ultrasound examinations were performed. Endometrial thickness was measured in the medio-sagittal section as double-layer in millimeters. Summary statistics for change from baseline in endometrial thickness was provided in below table.

    Measured: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2018
  2. Study start24 Jan 2018
  3. Primary completion23 Mar 2019
  4. Study completion30 Jun 2021

Why it stopped: Due to a change in the development program, the study was closed prematurely.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03400956
Sponsor's protocol ID
15790
Other IDs
2016-003561-26, 2016
Status last verified
Jun 2022
First submitted
5 Jan 2018
Last updated
30 Jun 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vilaprisan (BAY1002670) in people with Uterine Fibroids, run by Bayer at 87 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Japan, Russia, Czechia, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Amenorrhea (time frame: The last 28 days of treatment period 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03400956.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.

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