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Uterine FibroidsPhase 3NCT03400943

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

A Phase 3 study testing Vilaprisan (BAY1002670) in people with Uterine Fibroids, run by Bayer at 103 sites in 9 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 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. 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)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
93 participants
Where
103 sitesin 9 countries
Study dates
17 Jan 2018to 6 Apr 2022
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 ≥ 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

103 sites in 9 countries.

103 sites in 9 countries

United States52 sites

  • California Center for Clinical Research

    Arcadia, California, 91007

  • Millennium Clinical Trials, LLC

    Arlington, Virginia, 22207

  • Georgia Center For Women

    Atlanta, Georgia, 30312

  • Agile Clinical Research Trials, LLC

    Atlanta, Georgia, 30328

  • Atlanta Women's Research Institute, Inc. - Alpharetta

    Atlanta, Georgia, 30342

  • Medisense, Inc.

    Atlanta, Georgia, 30363

  • Ideal Clinical Research

    Aventura, Florida, 33180

  • South Florida Medical Research

    Aventura, Florida, 33180

  • PharmaSite Research, Inc.

    Baltimore, Maryland, 21208

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-0026

  • Fellows Research Alliance, Inc.

    Bluffton, South Carolina, 29910

  • Helix Biomedics, LLC

    Boynton Beach, Florida, 33435

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Main Line Fertility Center

    Bryn Mawr, Pennsylvania, 19010

  • Core Healthcare Group

    Cerritos, California, 90703

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Carolinas Healthcare System

    Charlotte, North Carolina, 28204

  • Chattanooga Medical Research, LLC

    Chattanooga, Tennessee, 37404

  • Paramount Research Solutions-College Park

    College Park, Georgia, 30349

  • Dr. Victoria Garcia & Associates, LLC Doral Medical Research

    Doral, Florida, 33166

  • AVIVA Research

    Escondido, California, 92025

  • Texas Health Care, PLLC

    Fort Worth, Texas, 76104

  • Willowbend Health & Wellness Associates

    Frisco, Texas, 75035

  • Simmonds, Martin and Helmbrecht

    Gaithersburg, Maryland, 20878

  • Family Medicine Clinic

    Georgetown, Texas, 78626

  • Sweet Hope Research Specialty, Inc. - Hialeah

    Hialeah, Florida, 33016

  • Biopharma Informatic, Inc.

    Houston, Texas, 77043

  • Centex Studies, Inc.

    Houston, Texas, 77058

  • The Center for Clinical Trials, Inc.

    Houston, Texas, 77082

  • Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare

    Jacksonville, Florida, 32256

  • Altus Research

    Lake Worth, Florida, 33461

  • National Research Institute - Los Angeles

    Los Angeles, California, 90057

  • Axcess Medical Research, LLC

    Loxahatchee Groves, Florida, 33470

  • Clinical Neurosciences Solutions, Inc DBA CNS Healthcare

    Memphis, Tennessee, 38119

  • Ocean Blue Medical Research Center, Inc.

    Miami Springs, Florida, 33166

  • Unified Women's Clinical Research - Morehead City

    Morehead City, North Carolina, 28557

  • Paramount Research Solutions-Nashville

    Nashville, Tennessee, 37203

  • Eastern Carolina Women's Center

    New Bern, North Carolina, 28562

  • One Health Research Clinic

    Norcross, Georgia, 30093

  • Accelerated Enrollment Solutions a business of PPD

    Orlando, Florida, 32808

  • Clinical Research of Philadelphia, LLC

    Philadelphia, Pennsylvania, 19114

  • Discovery Clinical Research

    Plantation, Florida, 33324

  • Wake Research, Inc.

    Raleigh, North Carolina, 27612

  • Synexus Research, LLC

    Richmond, Virginia, 23226

  • ONCOVA Clinical Research, Inc.

    Saint Cloud, Florida, 34769

  • Fellows Research Alliance - Savannah

    Savannah, Georgia, 31406

  • GTC Research

    Shawnee Mission, Kansas, 66218

  • Omni Fertility and Laser Institute

    Shreveport, Louisiana, 71118

  • Advantia Health, LLC Obstetrics & Gynecology Assoc.

    Silver Spring, Maryland, 20910

  • Fusion Clinical Research of Spartanburg, LLC

    Spartanburg, South Carolina, 29301

  • Houston Center for Clinical Research, LLC

    Sugar Land, Texas, 77479

  • Harbor - UCLA Medical Center

    Torrance, California, 90509-2910

Other trials in United States

China29 sites

  • Beijing Hospital of Traditional Chinese Medicine

    Beijing, 100010

  • Peking University First Hospital

    Beijing, 100034

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, 100050

  • Beijing Tiantan Hospital, Captial Medical University

    Beijing, 100050

  • The First Hospital of Jilin University

    Changchun, Jilin, 130000

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

  • 900th Hospital of Joint Logistics Support Force

    Fuzhou, Fujian, 350025

  • Guangzhou Women and Children's Medical Center

    Guangzhou, Guangdong, 510623

  • The Third Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510630

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • Women's Hospital School of Medicine Zhejiang University

    Hangzhou, Zhejiang, 310006

  • Sir Run Run Shaw Hospital, Zhejiang University School of Med

    Hangzhou, Zhejiang, 310016

  • Jiangxi Maternal and Child Health Hospital

    Nanchang, Jiangxi, 330006

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Nanjing Maternity and Child Health Care Hospital

    Nanjing, Jiangsu, 210004

  • NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School

    Nanjing, Jiangsu, 210008

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

  • Shanghai East Hospital Affiated to Tongji University

    Shanghai, 200123

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110022

  • 1st Affiliated hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • The Second Affiliated Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

  • The Second Affliated Hospital of Wenzhou Medicial University

    Wenzhou, Zhejiang, 325000

  • Wuhan Tongji Reproductive Medicine Hospital

    Wuhan, Hubei, 430013

  • Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710004

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

  • Boai Hospital of Zhongshan

    Zhongshan, Guangdong

Other trials in China

Bulgaria4 sites

  • Multiprofile Hospital for Active Treatment-Dr. T. Venkova AD

    Gabrovo, 5300

  • Hospital for Active Treatment - Prof.Paraskev Stoyanov AD

    Lovech, 5500

  • MHAT Dr. Bratan Shukerov AD

    Smolyan, 4700

  • MHAT for Women's Health - Nadezhda OOD

    Sofia, 1330

Other trials in Bulgaria

Czechia4 sites

  • Gynekologie MEDA s.r.o.

    Brno, 602 00

  • Soukroma gynekologicka ambulance

    Fulnek, 74245

  • Gynekologie Studentsky dum s.r.o.

    Prague, 160 00

  • MUDr. Ivana Salamonova s.r.o.

    Vysoké Mýto, 566 01

Other trials in Czechia

Israel4 sites

  • Clalit Health Services through HaEmek Medical Center

    Afula, 1834111

  • Hillel Yaffe Medical Center

    Hadera, 3810101

  • Lady Davis Carmel Medical Center

    Haifa, 3436212

  • Meir Medical Center

    Kfar Saba, 4428164

Other trials in Israel

South Africa4 sites

  • Umhlanga Medical Centre

    Durban, KwaZulu-Natal, 4319

  • Ethekwini Hospital & Heart Centre

    Durban, KwaZulu-Natal

  • Dr L Reynders Practice

    Lyttelton Manor, Gauteng, 0141

  • Wilgeheuwel Hospital

    Roodepoort, Gauteng, 1724

Other trials in South Africa

Malaysia3 sites

  • University Hospital Kebangsaan Malaysia

    Kuala Lumpur, 56000

  • Hospital Wanita dan Kanak-Kanak Sabah

    Sabak Bernam, 88996

  • Sarawak General Hospital

    Sarawak, 93400

Other trials in Malaysia

New Zealand2 sites

  • P3 Research Ltd Hawkes Bay

    Hawkes Bay, 4130

  • P3 Research

    Tauranga, 3110

Other trials in New Zealand

Singapore1 site

  • KK Women's and Children's Hospital

    Singapore, 229899

Other trials in Singapore

About this study

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

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.

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

    2 mg of Vilaprisan once daily up to 2 x 12 weeks

  • PlaceboDrug

    Matching placebo was administered to group B1 and B2.

Study groups in NCT03400943
Study groupRoleWhat they receive
Vilaprisan (A1)ExperimentalVilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Receives: Drug: Vilaprisan (BAY1002670); Drug: Placebo
Vilaprisan (A2)ExperimentalVilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
Receives: Drug: Vilaprisan (BAY1002670)
Placebo+Vilaprisan (B1)ExperimentalPlacebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
Receives: Drug: Vilaprisan (BAY1002670); Drug: Placebo
Vilaprisan+Placebo (B2)ExperimentalVilaprisan (2 mg) 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 measured by 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 response was defined as MBL <80 mL during the last 28 days of treatment and >50% reduction from baseline based on 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).

    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 based on 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 Uterine Fibroid Daily Bleeding Diary (UF-DBD).

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

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

    Number of participants with endometrial histology findings, e.g. benign endometrium, Malignant Neoplasm, Hyperplasia WHO 2014, no atypia or Hyperplasia WHO 2014, atypia and Endometrial Polyps.

    Measured: Up to 2 weeks after end of treatment

  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: Treatment phase (up to 2 weeks after end of treatment) and follow-up phase (starts on the day after the end of the treatment until the last study visit [up to approximately 2 years])

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 start17 Jan 2018
  3. Primary completion9 Jun 2019
  4. Study completion6 Apr 2022

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
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03400943
Sponsor's protocol ID
15787
Other IDs
2017-002997-38, 2017
Status last verified
Apr 2023
First submitted
5 Jan 2018
Last updated
3 May 2023
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.vivli.org 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 member section of the portal.

Publications

  • Al-Hendy A, Zhou YF, Faustmann T, Groettrup-Wolfers E, Laapas K, Parke S, Seitz C. Efficacy and safety of vilaprisan in women with uterine fibroids: data from the ASTEROID 3 randomized controlled trial. F S Sci. 2023 Nov;4(4):317-326. doi: 10.1016/j.xfss.2023.06.003. Epub 2023 Jul 10.

    PubMed 37437885

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 103 sites in 9 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 9 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 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in United States, China, Bulgaria, Czechia, Israel and 4 more countries. 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 11 Jun 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 NCT03400943, which also lists 1 linked publication.

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 3 May 2023.

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