LeiomyomaPhase 2ASTEROID 1NCT02131662

Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap

A Phase 2 study testing BAY1002670 in people with Leiomyoma, run by Bayer at 105 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The study is performed to assess the efficacy and safety of different doses of BAY1002670 in subjects with uterine fibroids. The dose-response relationship will be evaluated. Further, the study aims to establish a population pharmacokinetic/pharmacodynamic relationship for BAY1002670 in subjects with uterine fibroids. Read more about this study

Who is it for?: Ages 18 to 50 years, women only
Conditions the study is for: Leiomyoma
What is being tested?: BAY1002670
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 309 participants
Where: 105 sitesin 13 countries
Study dates: 15 May 2014to 4 May 2016
Phase: Phase 2
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 to 50 years
Women only
No healthy volunteers
Adult

Who may be able to join

Signed and dated informed consent
Diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter 3.0 cm
18 to 50 years of age at the time of screening
Heavy menstrual bleeding >80 mL documented by MP during the bleeding episode following the screening visit
Normal or clinically insignificant cervical smear not requiring further follow-up
An endometrial biopsy performed at the screening visit 1 (Visit 1), without significant histological disorder such as endometrial hyperplasia or other significant endometrial pathology
Use of a non-hormonal barrier method of contraception starting at the bleeding episode following the screening visit 1 (Visit 1) until the end of the study
Good general health (except for findings related to uterine fibroids)

Who cannot join

Pregnancy or lactation
Uterine fibroid with largest diameter >10.0 cm
Hypersensitivity to any ingredient of the study drug
Laboratory values outside inclusion range before randomization and considered as clinically relevant
Hemoglobin values <6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values <10.9 g/dL will receive 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

Trial locations and contacts

105 sites in 13 countries.

Country

City, postcode or hospital

105 sites in 13 countries

United States36 sites

Study site
Chattanooga, Tennessee, 37404
Study site
Cleveland, Ohio, 44195
Study site
Columbus, Ohio, 43231
Study site
Dallas, Texas, 75231
Study site
Denver, Colorado, 80209
Study site
Durham, North Carolina, 27713
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Frisco, Texas, 75035
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Gainesville, Florida, 32606
Study site
Houston, Texas, 77030
Study site
Houston, Texas, 77054
Study site
Jacksonville, Florida, 32207
Study site
Lincoln, Nebraska, 68510
Study site
Marrero, Louisiana, 70072
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Mesa, Arizona, 85209
Study site
Moorestown, New Jersey, 08057
Study site
Naperville, Illinois, 60540
Study site
Neptune City, New Jersey, 07753
Study site
New Brunswick, New Jersey, 08901
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New York, New York, 10038
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Newburgh, Indiana, 47630
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Norfolk, Virginia, 23507
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Philadelphia, Pennsylvania, 19104
Study site
Philadelphia, Pennsylvania, 19114
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Pittsburgh, Pennsylvania, 15206
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Pittsburgh, Pennsylvania, 15213-3180
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Plantation, Florida, 33324
Study site
Portland, Oregon, 97239-3011
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Raleigh, North Carolina, 27612
Study site
San Diego, California, 92103
Study site
San Diego, California, 92108
Study site
Sandy Springs, Georgia, 30328
Study site
Seattle, Washington, 98105
Study site
South Miami, Florida, 33143
Study site
Southington, Connecticut, 06489
Study site
Tucson, Arizona, 85712
Study site
Washington D.C., District of Columbia, 20036

Other trials in United States

Japan13 sites

Study site
Iizuka, Fukuoka, 820-8505
Study site
Kanazawa, Ishikawa-ken, 920-8530
Study site
Kita-ku, Tokyo, 115-0053
Study site
Kōriyama, Fukushima, 963-8585
Study site
Kumamoto, 862-8505
Study site
Matsudo, Chiba, 270-2267
Study site
Nagano, 381-8551
Study site
Nakano-ku, Tokyo, 164-8541
Study site
Numazu, Shizuoka, 410-8555
Study site
Ōmura, Nagasaki, 856-8562
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Sapporo, Hokkaido, 004-0052
Study site
Sapporo, Hokkaido, 064-0808
Study site
Tacchikawa, Tokyo, 190-8531

Other trials in Japan

Germany9 sites

Study site
Berlin, 12200
Study site
Bernburg, Saxony-Anhalt, 06406
Study site
Blankenburg, Saxony-Anhalt, 38889
Study site
Dresden, Saxony, 01307
Study site
Erlangen, Bavaria, 91054
Study site
Geseke, North Rhine-Westphalia, 59590
Study site
Ilsede, 31241
Study site
Karlsruhe, Baden-Wurttemberg, 76199
Study site
Lübeck, Schleswig-Holstein, 23538

Other trials in Germany

Czechia6 sites

Study site
České Budějovice, 370 01
Study site
Hradec Králové, 500 05
Study site
Olomouc, 772 00
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Písek, 39701
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Prague, 12808
Study site
Prague, 13000

Other trials in Czechia

Spain6 sites

Study site
Aravaca, Madrid, 28023
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Barcelona, 08028
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Barcelona, 08035
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Seville, 41013
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Seville, 41014
Study site
Valencia, 46017

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Belgium5 sites

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Bruxelles - Brussel, 1070
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Bruxelles - Brussel, 1200
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Charleroi, 6000
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Leuven, 3000
Study site
Liège, 4000

Other trials in Belgium

Bulgaria5 sites

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Pleven, 5800
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Sofia, 1504
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Sofia, 1606
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Sofia, 1797
Study site
Stara Zagora, 6000

Other trials in Bulgaria

Canada5 sites

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Hamilton, Ontario, L8S 4K1
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Ottawa, Ontario, K1H 7W9
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Pointe-Claire, Quebec, H9R 4S3
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Québec, G1S 2L6
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Winnipeg, Manitoba, R3T 2E8

Other trials in Canada

Finland5 sites

Study site
Espoo, 02100
Study site
Helsinki, 00260
Study site
Joensuu, 80100
Study site
Kuopio, 70110
Study site
Oulu, 90100

Other trials in Finland

Hungary5 sites

Study site
Debrecen, 4024
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Debrecen, 4032
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Kecskemét, 6000
Study site
Szeged, 6725
Study site
Szentes, 6600

Other trials in Hungary

Norway5 sites

Study site
Nesttun, 5221
Study site
Oslo, 0407
Study site
Sellebakk, 1653
Study site
Trondheim, 7006
Study site
Trondheim, 7014

Other trials in Norway

Sweden4 sites

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Gothenburg, 411 18
Study site
Örebro, 701 85
Study site
Stockholm, 171 76
Study site
Uppsala, 751 85

Other trials in Sweden

Switzerland1 site

Study site
Bern, 3010

Other trials in Switzerland

About this study

Official title: A Randomized, Parallel-group, Double-blind, Placebo Controlled, Multi-center Study to Assess the Efficacy and Safety of Different Doses of BAY1002670 in Subjects With Uterine Fibroids Over 3 Months

Conditions: Leiomyoma
Being tested: BAY1002670, Placebo
Keywords: Uterine fibroids
Medical subject headings: Leiomyoma

What participants receive

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

BAY1002670Drug
Subjects received 4 milligram (mg) Vilaprisan (VPR) tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
BAY1002670Drug
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
BAY1002670Drug
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
BAY1002670Drug
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
PlaceboDrug
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.

Study groups in NCT02131662
Study group	Role	What they receive
VPR 4 mg	Experimental	Not described Receives: Drug: BAY1002670
VPR 2 mg	Experimental	Not described Receives: Drug: BAY1002670
VPR 1 mg	Experimental	Not described Receives: Drug: BAY1002670
VPR 0.5 mg	Experimental	Not described Receives: Drug: BAY1002670
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Percentage of Subjects With Amenorrhea, Defined as no Scheduled or Unscheduled Bleeding/Spotting After the End of the Initial Bleeding Episode Until End of Treatment
Amenorrhea was defined as no scheduled or unscheduled bleeding/spotting after the end of the initial bleeding episode until end of treatment. Dose-response curve was estimated based on the primary endpoint. The 4 parameters characterizing the dose-response curve were reported in other pre-specified endpoints below.
Measured: After end of the initial bleeding episode until the end of treatment, up to 12 weeks

Secondary outcomes (3)

Change in Volume of Menstrual Blood Loss Per 28 Days From Baseline During Treatment by Reference Period (Assessed by Alkaline Hematin Method)
In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint for each arm, respectively.
Measured: From baseline to end of follow-up
Time to Onset of Controlled Bleeding
Onset of controlled bleeding was defined by the first day, for which the MBL (assessed by MP, Version 2014) for all subsequent 28-day periods up to the end of the treatment period was less than 80 mL. Kaplan-Meier estimated time to onset of controlled bleeding (days) was reported.
Measured: During treatment period
Change in Volume of Largest Fibroid Compared to Baseline Measured by MRI
Pelvic Magnetic resonance imagings (MRI), without contrast agents, were performed for volume measurements of the uterus and fibroids preferably using 1.5 Tesla scanners or higher. Images were sent to the imaging core laboratory for evaluation. Volume measurements of the uterus and fibroids were performed centrally by independent radiologist(s).
Measured: From baseline to end of follow-up period

Timeline

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

15 May 20144 May 2016

First posted6 May 2014 (estimated)
Study start15 May 2014
Primary completion4 May 2016
Study completion4 May 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for LeiomyomaStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 309 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02131662
Sponsor's protocol ID: 15788
Other IDs: 2013-003945-40
Acronym: ASTEROID 1
Status last verified: Nov 2017
First submitted: 5 May 2014
Last updated: 8 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Ren X, Xia J. An algorithm for computing profile likelihood based pointwise confidence intervals for nonlinear dose-response models. PLoS One. 2019 Jan 25;14(1):e0210953. doi: 10.1371/journal.pone.0210953. eCollection 2019.
PubMed 30682081
Bradley LD, Singh SS, Simon J, Gemzell-Danielsson K, Petersdorf K, Groettrup-Wolfers E, Ren X, Zvolanek M, Seitz C. Vilaprisan in women with uterine fibroids: the randomized phase 2b ASTEROID 1 study. Fertil Steril. 2019 Feb;111(2):240-248. doi: 10.1016/j.fertnstert.2018.10.012. Epub 2018 Dec 7.
PubMed 30527839

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy

All Leiomyoma trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Parallel-group, Double-blind, Placebo Controlled, Multi-center Study to Assess the Efficacy and Safety of Different Doses of BAY1002670 in Subjects With Uterine Fibroids Over 3 Months
ClinicalTrials.gov ID: NCT02131662
Acronym / sponsor ID: ASTEROID 1 / 15788
Conditions: Leiomyoma
Keywords: Uterine fibroids
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 309 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 15 May 2014 (actual)
Primary completion: 4 May 2016 (actual)
Study completion: 4 May 2016 (actual)
First posted: 6 May 2014 (estimated)
Results: Posted 8 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
VPR 4 mg	Experimental	Drug: BAY1002670
VPR 2 mg	Experimental	Drug: BAY1002670
VPR 1 mg	Experimental	Drug: BAY1002670
VPR 0.5 mg	Experimental	Drug: BAY1002670
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Signed and dated informed consent
Diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter 3.0 cm
18 to 50 years of age at the time of screening
Heavy menstrual bleeding >80 mL documented by MP during the bleeding episode following the screening visit
Normal or clinically insignificant cervical smear not requiring further follow-up

Key exclusion criteria (6 listed)

Pregnancy or lactation
Uterine fibroid with largest diameter >10.0 cm
Hypersensitivity to any ingredient of the study drug
Laboratory values outside inclusion range before randomization and considered as clinically relevant
Hemoglobin values <6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values <10.9 g/dL will receive iron supplementation)

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
BAY1002670Subjects received 4 milligram (mg) Vilaprisan (VPR) tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.	Drug	VPR 4 mg
BAY1002670Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.	Drug	VPR 2 mg
BAY1002670Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.	Drug	VPR 1 mg
BAY1002670Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.	Drug	VPR 0.5 mg
PlaceboSubjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.	Drug	Placebo

Primary outcome

Percentage of Subjects With Amenorrhea, Defined as no Scheduled or Unscheduled Bleeding/Spotting After the End of the Initial Bleeding Episode Until End of Treatment
Time frame: After end of the initial bleeding episode until the end of treatment, up to 12 weeks
Amenorrhea was defined as no scheduled or unscheduled bleeding/spotting after the end of the initial bleeding episode until end of treatment. Dose-response curve was estimated based on the primary endpoint. The 4 parameters characterizing the dose-response curve were reported in other pre-specified endpoints below.

3 secondary outcomes

Change in Volume of Menstrual Blood Loss Per 28 Days From Baseline During Treatment by Reference Period (Assessed by Alkaline Hematin Method)
Time frame: From baseline to end of follow-up
Time to Onset of Controlled Bleeding
Time frame: During treatment period
Change in Volume of Largest Fibroid Compared to Baseline Measured by MRI
Time frame: From baseline to end of follow-up period

Results and safety

Results posted to the registry on 8 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VPR 4 mg	62	54
VPR 2 mg	61	47
VPR 1 mg	63	56
VPR 0.5 mg	62	41
Placebo	61	43

Primary outcome: Percentage of Subjects With Amenorrhea, Defined as no Scheduled or Unscheduled Bleeding/Spotting After the End of the Initial Bleeding Episode Until End of Treatment

Time frame: After end of the initial bleeding episode until the end of treatment, up to 12 weeks. Number. Unit: Percentage of subjects

Measure	VPR 4 mg n = 60	VPR 2 mg n = 61	VPR 1 mg n = 61	VPR 0.5 mg n = 60	Placebo n = 58
Value	60	54.1	55.7	30	1.7

VPR 4 mg vs Placebo: Percentage difference: 58.28 (95% CI 44.55 to 70.94)
VPR 2 mg vs Placebo: Percentage difference: 52.37 (95% CI 38.8 to 65.42)
VPR 1 mg vs Placebo: Percentage difference: 54.01 (95% CI 40.41 to 66.95)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of study treatment until the end of the 6-month follow-up period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VPR 4 mg	2 of 60 (3.3%)	31 of 60 (51.7%)	Not reported
VPR 2 mg	4 of 61 (6.6%)	30 of 61 (49.2%)	Not reported
VPR 1 mg	3 of 61 (4.9%)	31 of 61 (50.8%)	Not reported
VPR 0.5 mg	2 of 60 (3.3%)	32 of 60 (53.3%)	Not reported
Placebo	2 of 58 (3.4%)	32 of 58 (55.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30682081Ren X, Xia J. An algorithm for computing profile likelihood based pointwise confidence intervals for nonlinear dose-response models. PLoS One. 2019 Jan 25;14(1):e0210953. doi: 10.1371/journal.pone.0210953. eCollection 2019.
Derived from this study: PubMed 30527839Bradley LD, Singh SS, Simon J, Gemzell-Danielsson K, Petersdorf K, Groettrup-Wolfers E, Ren X, Zvolanek M, Seitz C. Vilaprisan in women with uterine fibroids: the randomized phase 2b ASTEROID 1 study. Fertil Steril. 2019 Feb;111(2):240-248. doi: 10.1016/j.fertnstert.2018.10.012. Epub 2018 Dec 7.
Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.

Related trials for Leiomyoma

Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy

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.

Bayer Study Director study director

Bayer

105 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAY1002670 in people with Leiomyoma, run by Bayer at 105 sites in 13 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in United States, Japan, Germany, Czechia, Spain and 8 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 8 Dec 2017). 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?

Percentage of Subjects With Amenorrhea, Defined as no Scheduled or Unscheduled Bleeding/Spotting After the End of the Initial Bleeding Episode Until End of Treatment (time frame: After end of the initial bleeding episode until the end of treatment, up to 12 weeks). 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 NCT02131662, which also lists 2 linked publications.

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 Dec 2017.