Uterine FibroidsPhase 3ASTEROID 7NCT03699176
Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
A Phase 3 study testing Vilaprisan (BAY1002670) in people with Uterine Fibroids, run by Bayer at 8 sites in Japan.
Trial summary
The primary objective of this study is 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 are 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
- 0 participants
- Where
- 8 sitesJapan
- Study dates
- 27 Oct 2018to 25 Dec 2019
- 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
- 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 of ≥ 30 mm (alternatively, of 30 mm or more)
- 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 menstrual pictogram (MP)
- 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
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 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Funabashi Municipal Medical Center
Funabashi, Chiba, 273-8588
Unoki Clinic
Kagoshima, 892-0826
Japanese Red Cross Kumamoto Hospital
Kumamoto, 861-8520
Matsudo City General Hospital
Matsudo, Chiba, 270-2296
Ena Odori Clinic
Sapporo, Hokkaido, 060-0001
Tokeidai Memorial Clinic
Sapporo, Hokkaido, 060-0031
Asahi clinic
Takamatsu, Kagawa-ken, 760-0076
Kagawa Prefectural Central Hospital
Takamatsu, Kagawa-ken, 760-8557
About this study
Official title: A Randomized, Parallel-group, Double-blind Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
The primary objective of this study is 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 are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.
- Conditions
- Uterine Fibroids
- Being tested
- Vilaprisan (BAY1002670), Placebo
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vilaprisan (BAY1002670)Drug
2 mg, once daily, oral
PlaceboDrug
Once daily, oral
| Study group | Role | What they receive |
|---|---|---|
| Vilaprisan | Experimental | 2 treatment periods of 12 weeks without a break Receives: Drug: Vilaprisan (BAY1002670) |
| Placebo | Placebo comparator | 2 treatment periods of 12 weeks without a break Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amenorrhea (yes/no)
Defined as menstrual blood loss (MBL) <2 mL (based on menstrual pictogram)
Measured: Up to 24 weeks (The last 28 days of treatment period 2)
Secondary outcomes (6)
Heavy menstrual bleeding (HMB) response (yes/no)
Defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline
Measured: Up to 24 weeks (the last 28 days of treatment period 2)
Time to onset of amenorrhea
Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2mL.
Measured: Up to 24 weeks
Time to onset of controlled bleeding
Onset of controlled bleeding is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL.
Measured: Up to 24 weeks
Absence of bleeding (spotting allowed) based on the Uterine Fibroid Daily Bleeding Diary (UF-DBD)
Measured: Up to 24 weeks (the last 28 days of treatment period 2)
Endometrial histology (eg, benign endometrium, presence or absence of hyperplasia or malignancy)
Measured: Up to 36 weeks
Endometrial thickness
Measured: Up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start27 Oct 2018
- Primary completion25 Dec 2019
- Study completion25 Dec 2019
Why it stopped: No patient was recruited, study withdrawn for feasibility reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699176
- Sponsor's protocol ID
- 19434
- Acronym
- ASTEROID 7
- Status last verified
- Jan 2020
- First submitted
- 5 Oct 2018
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-group, Double-blind Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
- ClinicalTrials.gov ID
- NCT03699176
- Acronym / sponsor ID
- ASTEROID 7 / 19434
- Conditions
- Uterine Fibroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patient was recruited, study withdrawn for feasibility reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2018 (actual)
- Primary completion
- 25 Dec 2019 (actual)
- Study completion
- 25 Dec 2019 (actual)
- First posted
- 9 Oct 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.
The primary objective of this study is 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 are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vilaprisan | Experimental | Drug: Vilaprisan (BAY1002670)2 treatment periods of 12 weeks without a break |
| Placebo | Placebo comparator | Drug: Placebo2 treatment periods of 12 weeks without a break |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 of ≥ 30 mm (alternatively, of 30 mm or more)
- 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 menstrual pictogram (MP)
- 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
Key exclusion criteria (7 listed)
- 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)
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)2 mg, once daily, oral | Drug | Vilaprisan |
| PlaceboOnce daily, oral | Drug | Placebo |
Primary outcome
Amenorrhea (yes/no)
Time frame: Up to 24 weeks (The last 28 days of treatment period 2)
Defined as menstrual blood loss (MBL) <2 mL (based on menstrual pictogram)
6 secondary outcomes
Heavy menstrual bleeding (HMB) response (yes/no)
Time frame: Up to 24 weeks (the last 28 days of treatment period 2)
Time to onset of amenorrhea
Time frame: Up to 24 weeks
Time to onset of controlled bleeding
Time frame: Up to 24 weeks
Absence of bleeding (spotting allowed) based on the Uterine Fibroid Daily Bleeding Diary (UF-DBD)
Time frame: Up to 24 weeks (the last 28 days of treatment period 2)
Endometrial histology (eg, benign endometrium, presence or absence of hyperplasia or malignancy)
Time frame: Up to 36 weeks
Endometrial thickness
Time frame: Up to 36 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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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.
8 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, run by Bayer at 8 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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. Some participants in this study may receive a placebo. 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 withdrawn before enrolling participants, so there are no results.
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?
Amenorrhea (yes/no) (time frame: Up to 24 weeks (The last 28 days of treatment period 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2020.