Uterine Fibroids and Heavy Menstrual BleedingPhase 3ASTEROID 8NCT03476928
A Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding
A Phase 3 study testing Vilaprisan (BAY1002670) in people with Uterine Fibroids and Heavy Menstrual Bleeding, run by Bayer at 25 sites in Japan.
Trial summary
To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (HMB). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Fibroids and Heavy Menstrual Bleeding
- What is being tested?
- Vilaprisan (BAY1002670)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 25 sitesJapan
- Study dates
- 30 Mar 2018to 12 Jul 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- 18 years or older
- Diagnosis of uterine fibroid(s) documented by ultrasound at screening
- Heavy menstrual bleeding (HMB) >80.00 mL associated with uterine fibroid(s)
- Good general health
- Normal or clinically insignificant cervical smear
- An endometrial biopsy performed during the screening period, without significant histological disorder
- Use of an acceptable nonhormonal method of contraception 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
- Any condition requiring immediate blood transfusion
- 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 the results
- Undiagnosed abnormal genital bleeding
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Japan25 sites
Sei Womens Clinic
Bunkyo, Tokyo, 112-0014
St.Luke's International Hospital
Chuoku, Tokyo, 104-8560
Akazawa Clinic
Fuchū, Tokyo, 183-0056
Kato Internal medicine and Gynecology Clinic
Fukui, 910-0845
Hamanomachi Hospital
Fukuoka, 810-8539
Kyoritsu Narashinodai Hospital
Funabashi, Chiba, 274-0063
Aso Iizuka Hospital
Iizuka, Fukuoka, 820-8505
Jusendo Geneal Hospital Yuasa Foundation
Kōriyama, Fukushima, 963-8585
Kurashiki Medical Clinic
Kurashiki, Okayama-ken, 710-0824
Toranomon Womens Clinic
Minato, Tokyo, 105-0001
Akasakamitsuke Miyazaki Obstetrics and Gynecology Clinic
Minato, Tokyo, 107-0051
Yokokura Clinic
Minato-ku, Tokyo, 108-0014
Meitetsu Hospital
Nagoya, Aichi-ken, 451-8511
Kano's Clinic for Women
Nagoya, Aichi-ken, 460-0011
Medical corporation keizukai Chayamachi Ladies Clinic
Osaka, 530-0013
Medical Corporation Koshinkai Nomura Clinic Namba
Osaka, 542-0076
Izuma Clinic
Osaka, 543-0023
Hashimoto Clinic
Sapporo, Hokkaido, 004-0052
Yoshio Clinic
Sapporo, Hokkaido, 064-0808
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666
Shizuoka Saiseikai General Hospital
Shizuoka, 422-8527
Medical Topia Soka Hospital
Sōka, Saitama, 340-0028
Asahi-Clinic.
Takamatsu, Kagawa-ken, 760-0076
Sato Hospital
Takasaki, Gunma, 370-0836
Toyama Prefectural Central Hospital
Toyama, 930-8550
About this study
Official title: An Open-label, Parallel-group, Randomized, Multicenter Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding
To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (HMB).
- Being tested
- Vilaprisan (BAY1002670)
- 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
2mg, once daily, oral
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A1 | Experimental | 4 treatment periods of 12 weeks, each separated by 1 bleeding episode Receives: Drug: Vilaprisan (BAY1002670) |
| Treatment Group A2 | Experimental | 2 treatment periods of 24 weeks, separated by 2 bleeding episodes Receives: Drug: Vilaprisan (BAY1002670) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse event
Measured: Up to one year and 3 months
Secondary outcomes (1)
Number of bleeding days
Measured: Up to one year and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start30 Mar 2018
- Primary completion12 Jul 2021
- Study completion12 Jul 2021
Why it stopped: Due to a change in the development program, the study was closed prematurely.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine Fibroids and Heavy Menstrual BleedingStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476928
- Sponsor's protocol ID
- 19435
- Acronym
- ASTEROID 8
- Status last verified
- Jun 2022
- First submitted
- 20 Mar 2018
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, time point 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.
Publications
Momoeda M, Faustmann T, Groettrup-Wolfers E, Kondo M, Yasuda M, Seitz C. Safety and efficacy of vilaprisan in Japanese women with fibroids: The Phase 3 ASTEROID 8 trial. Womens Health (Lond). 2025 Jan-Dec;21:17455057251378954. doi: 10.1177/17455057251378954. Epub 2025 Oct 8.
PubMed 41059527
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Parallel-group, Randomized, Multicenter Study to Assess the Safety and Efficacy of Vilaprisan in Japanese Subjects With Uterine Fibroids and Heavy Menstrual Bleeding
- ClinicalTrials.gov ID
- NCT03476928
- Acronym / sponsor ID
- ASTEROID 8 / 19435
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to a change in the development program, the study was closed prematurely.
- Enrolment
- 153 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 12 Jul 2021 (actual)
- Study completion
- 12 Jul 2021 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of vilaprisan in Japanese subjects with uterine fibroids and heavy menstrual bleeding (HMB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A1 | Experimental | Drug: Vilaprisan (BAY1002670)4 treatment periods of 12 weeks, each separated by 1 bleeding episode |
| Treatment Group A2 | Experimental | Drug: Vilaprisan (BAY1002670)2 treatment periods of 24 weeks, separated by 2 bleeding episodes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older
- Diagnosis of uterine fibroid(s) documented by ultrasound at screening
- Heavy menstrual bleeding (HMB) >80.00 mL associated with uterine fibroid(s)
- Good general health
- Normal or clinically insignificant cervical smear
Key exclusion criteria (8 listed)
- Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
- Hypersensitivity to any ingredient of the study drug
- Any condition requiring immediate blood transfusion
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vilaprisan (BAY1002670)2mg, once daily, oral | Drug | Treatment Group A1, Treatment Group A2 |
Primary outcome
Incidence of treatment-emergent adverse event
Time frame: Up to one year and 3 months
1 secondary outcome
Number of bleeding days
Time frame: Up to one year and 3 months
Results and safety
The study was stopped early (reason given: Due to a change in the development program, the study was closed prematurely.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Derived from this study: PubMed 41059527Momoeda M, Faustmann T, Groettrup-Wolfers E, Kondo M, Yasuda M, Seitz C. Safety and efficacy of vilaprisan in Japanese women with fibroids: The Phase 3 ASTEROID 8 trial. Womens Health (Lond). 2025 Jan-Dec;21:17455057251378954. doi: 10.1177/17455057251378954. Epub 2025 Oct 8.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, time point 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vilaprisan (BAY1002670) in people with Uterine Fibroids and Heavy Menstrual Bleeding, run by Bayer at 25 sites in Japan.
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 7 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 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Japan. 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?
The study was stopped early (reason given: Due to a change in the development program, the study was closed prematurely.). Results are not available in the source record.
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?
Incidence of treatment-emergent adverse event (time frame: Up to one year and 3 months). 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 NCT03476928, 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 8 Jul 2022.