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LeiomyomaPhase 2ASTEROID 2NCT02465814

Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids

A Phase 2 study testing Vilaprisan (BAY1002670), Vilaprisan (BAY1002670 and Ulipristal in people with Leiomyoma, run by Bayer at 64 sites in 16 countries.

Completed

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

Official record
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Trial summary

The study is performed to assess the efficacy of Vilaprisan (BAY1002670) in patients with uterine fibroids compared to placebo and ulipristal. It is also aimed to evaluate the safety of vilaprisan 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?
Vilaprisan (BAY1002670), Vilaprisan (BAY1002670 and Ulipristal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
64 sitesin 16 countries
Study dates
Jun 2015to Oct 2016
Phase
Phase 2
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 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Women, 18 to 50 years of age at the time of screening
  • Diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter >/=3.0 cm
  • Heavy menstrual bleeding (HMB) >80 mL documented by menstrual pictogram (MP) in a bleeding episode during the screening period. Women who did not suffer from perceived HMB during the 3 months prior to Visit 1 due to any effective medical treatment, e.g. with a hormonal contraceptive, are not considered appropriate candidates and should not undergo further screening procedures. Women suffering from perceived HMB despite medical treatment, e.g. with a hormonal contraceptive, are appropriate candidates for further screening, if rules on stopping prior medication are followed. Heavy menstrual bleeding /HMB) > 80 mL should be documented within 10 consecutive days.
  • Good general health (except for findings related to uterine fibroids) as proven by medical history, physical and gynecological examinations, and laboratory test results
  • Normal or clinically insignificant cervical smear not requiring further follow-up. Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASCUS) can be used as an adjunctive test. Subjects with ASCUS can be included if they are negative for high-risk HPV strains.
  • 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 nonhormonal method of contraception (i.e. either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at the bleeding episode following the screening visit 1 (Visit 1) until the end of the study. This is not required if safe contraception is achieved by a permanent method, such as bilateral fallopian tube blockage of the subject or vasectomy of the partner(s).

Who cannot join

  • Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
  • Uterine fibroid with largest diameter >10.0 cm
  • 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 offered 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
  • 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 (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

64 sites in 16 countries.

64 sites in 16 countries

Czechia9 sites

  • Study site

    Brno, 625 00

  • Study site

    České Budějovice, 37001

  • Study site

    Olomouc, 772 00

  • Study site

    Olomouc, 775 20

  • Study site

    Pilsen, 30708

  • Study site

    Písek, 39701

  • Study site

    Prague, 120 00

  • Study site

    Prague, 13000

  • Study site

    Prague, 180 81

Other trials in Czechia

Poland5 sites

  • Study site

    Bialystok, 15- 224

  • Study site

    Lodz, 90-602

  • Study site

    Lublin, 20-093

  • Study site

    Lublin, 20-632

  • Study site

    Warsaw, 02-507

Other trials in Poland

Austria4 sites

  • Study site

    Graz, Styria, 8036

  • Study site

    Innsbruck, Tyrol, 6020

  • Study site

    Vienna, State of Vienna, 1090

  • Study site

    Villach, Carinthia, 9500

Other trials in Austria

Bulgaria4 sites

  • Study site

    Pleven, 5800

  • Study site

    Sofia, 1504

  • Study site

    Sofia, 1606

  • Study site

    Stara Zagora, 6000

Other trials in Bulgaria

Germany4 sites

  • Study site

    Berlin, State of Berlin, 10787

  • Study site

    Bernburg, Saxony-Anhalt, 06406

  • Study site

    Blankenburg, Saxony-Anhalt, 38889

  • Study site

    Dresden, Saxony, 01307

Other trials in Germany

Hungary4 sites

  • Study site

    Budapest, 1036

  • Study site

    Debrecen, 4024

  • Study site

    Debrecen, 4032

  • Study site

    Szentes, H-6600

Other trials in Hungary

Netherlands4 sites

  • Study site

    Almere Stad, 1315 RA

  • Study site

    Heerlen, 6419 PC

  • Study site

    Nieuwegein, 3435 CM

  • Study site

    Zwolle, 8025 AB

Other trials in Netherlands

Norway4 sites

  • Study site

    Fredrikstad, 1605

  • Study site

    Lørenskog, 1478

  • Study site

    Nesttun, 5221

  • Study site

    Stavanger, 4011

Other trials in Norway

Spain4 sites

  • Study site

    Aravaca, Madrid, 28023

  • Study site

    Barcelona, Barcelona, 08003

  • Study site

    Valencia, Valencia, 46010

  • Study site

    Valencia, Valencia, 46026

Other trials in Spain

United Kingdom4 sites

  • Study site

    Harrow, London, HA1 3UJ

  • Study site

    London, N19 5NF

  • Study site

    Nottingham, NG7 2UH

  • Study site

    Portsmouth, PO6 3LY

Other trials in United Kingdom

Belgium3 sites

  • Study site

    Bruxelles - Brussel, 1000

  • Study site

    Edegem, 2650

  • Study site

    Tienen, Vlaams Brabant, 3300

Other trials in Belgium

Finland3 sites

  • Study site

    Helsinki, 00610

  • Study site

    Pori, 28500

  • Study site

    Turku, 20100

Other trials in Finland

Italy3 sites

  • Study site

    Cagliari, Sardinia, 09042

  • Study site

    Catania, Sicily, 95123

  • Study site

    Modena, Emilia-Romagna, 41124

Other trials in Italy

Lithuania3 sites

  • Study site

    Vilnius, LT-05263

  • Study site

    Vilnius, LT-08217

  • Study site

    Vilnius, LT-10207

Other trials in Lithuania

Portugal3 sites

  • Study site

    Coimbra, Coimbra District, 3000-075

  • Study site

    Lisbon, Lisbon District, 1449-005

  • Study site

    Porto, Porto District, 4202-451

Other trials in Portugal

Sweden3 sites

  • Study site

    Stockholm, 118 83

  • Study site

    Stockholm, 171 76

  • Study site

    Umeå, 90185

Other trials in Sweden

About this study

Official title: A Randomized, Parallel-group, Double-blind Placebo-controlled and Open Label Active Controlled, Multi-center Study to Assess the Efficacy and Safety of Vilaprisan in Patients With Uterine Fibroids

The study is performed to assess the efficacy of Vilaprisan (BAY1002670) in patients with uterine fibroids compared to placebo and ulipristal. It is also aimed to evaluate the safety of vilaprisan in subjects with uterine fibroids. Further, data on population pharmacokinetic (PK)/ pharmacodynamic (PD) relationship for vilaprisan in subjects with uterine fibroids will be supplemented.

Conditions
Leiomyoma
Being tested
Vilaprisan (BAY1002670), Vilaprisan (BAY1002670, Ulipristal
Keywords
Uterine fibroids, 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

    Vilaprisan 2 mg (12 weeks), Vilaprisan 2 mg (12 weeks)

  • Vilaprisan (BAY1002670Drug

    Placebo (12 weeks),Vilaprisan (12 weeks)

  • Vilaprisan (BAY1002670Drug

    Vilaprisan 2 mg (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)

  • Vilaprisan (BAY1002670)Drug

    Placebo (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)

  • UlipristalDrug

    Ulipristal 5 mg (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)

  • UlipristalDrug

    Placebo (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)

  • UlipristalDrug

    Ulipristal (12 weeks), treatment break, Placebo (12 weeks)

Study groups in NCT02465814
Study groupRoleWhat they receive
Arm 1 - BAY1002670 + BAY1002670ExperimentalVilaprisan (BAY1002670) 2 mg once daily (12 weeks), Vilaprisan 2 mg once daily (12 weeks)
Receives: Drug: Vilaprisan (BAY1002670)
Arm 2 - Placebo + BAY1002670ExperimentalPlacebo once daily (12 weeks), Vilaprisan 2 mg once daily (12 weeks)
Receives: Drug: Vilaprisan (BAY1002670
Arm 3 - BAY1002670 + BAY1002670ExperimentalVilaprisan 2 mg once daily (12 weeks), treatment break, Vilaprisan 2 mg once daily (12 weeks)
Receives: Drug: Vilaprisan (BAY1002670
Arm 4 - Placebo+BAY1002670ExperimentalPlacebo once daily (12 weeks), treatment break, Vilaprisan 2 mg once daily(12 weeks)
Receives: Drug: Vilaprisan (BAY1002670)
Arm 5 - Ulipristal + UlipristalActive comparatorUlipristal 5 mg once daily (12 weeks), treatment break, Ulipristal 5 mg once daily (12 weeks)
Receives: Drug: Ulipristal
Arm 6- Placebo + UlipristalActive comparatorPlacebo once daily (12 weeks), treatment break, Ulipristal 5 mg once daily (12 weeks)
Receives: Drug: Ulipristal
Arm 7- Ulipristal + PlaceboActive comparatorUlipristal 5 mg once daily (12 weeks), treatment break, Placebo once daily (12 weeks)
Receives: Drug: Ulipristal

What is being measured

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

  1. Amenorrhea (yes/no)

    Defined as no scheduled or unscheduled bleeding/spotting after end of the initial bleeding episode until the end of the respective treatment period.

    Measured: From day 7 to day 84 of treatment.

Secondary outcomes (5)

  1. Number of bleeding days

    Measured: Up to 32 weeks

  2. Time to onset of controlled bleeding

    Measured: Up to 28 weeks

  3. Percent change in volume of largest fibroid from baseline to end of treatment.

    Measured: Baseline and up to 28 weeks

  4. Endometrial histology

    (Frequency of the following categories: benign endometrium, endometrial hyperplasia, malignant neoplasm)

    Measured: Baseline and up to 40 weeks

  5. Endometrial thickness measured by transvaginal ultrasound.

    Measured: Baseline and up to 40 weeks

Timeline

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

  1. First posted9 Jun 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionOct 2016
  4. Study completionOct 2016

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02465814
Sponsor's protocol ID
17541
Other IDs
2014-004221-41, 2014
Acronym
ASTEROID 2
Status last verified
Nov 2016
First submitted
22 May 2015
Last updated
22 Nov 2016
Results posted
No
Data monitoring committee
No

Publications

  • Gemzell-Danielsson K, Heikinheimo O, Zatik J, Poka R, Rechberger T, Hudecek R, Petersdorf K, Ramirez F, Faustmann T, Groettrup-Wolfers E, Seitz C. Efficacy and safety of vilaprisan in women with uterine fibroids: Data from the phase 2b randomized controlled trial ASTEROID 2. Eur J Obstet Gynecol Reprod Biol. 2020 Sep;252:7-14. doi: 10.1016/j.ejogrb.2020.05.043. Epub 2020 May 31.

    PubMed 32559602

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vilaprisan (BAY1002670), Vilaprisan (BAY1002670 and Ulipristal in people with Leiomyoma, run by Bayer at 64 sites in 16 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 7 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: finished, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in Czechia, Poland, Austria, Bulgaria, Germany and 11 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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: From day 7 to day 84 of treatment.). 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 NCT02465814, 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 22 Nov 2016.

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