Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids

NCT02465814 | Completed Phase 2

• 2 other identifiers: 175412014-004221-41
• Study Type: interventional
• Target: 120
• Locations: 16 countries
• Sites: 64

Brief 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. Further, data on population pharmacokinetic (PK)/ pharmacodynamic (PD) relationship for vilaprisan in subjects with uterine fibroids will be supplemented.

Conditions

Leiomyoma

Keywords

Uterine fibroids; Heavy Menstrual Bleeding

Outcome Measures

Primary Outcomes (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.

  From day 7 to day 84 of treatment.

Secondary Outcomes (5)

• Number of bleeding days

  Up to 32 weeks

• Time to onset of controlled bleeding

  Up to 28 weeks

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

  Baseline and up to 28 weeks

• Endometrial histology

  Baseline and up to 40 weeks

• Endometrial thickness measured by transvaginal ultrasound.

  Baseline and up to 40 weeks

Study Arms (7)

Arm 1 - BAY1002670 + BAY1002670

EXPERIMENTAL

Vilaprisan (BAY1002670) 2 mg once daily (12 weeks), Vilaprisan 2 mg once daily (12 weeks)

Drug: Vilaprisan (BAY1002670)

Arm 2 - Placebo + BAY1002670

EXPERIMENTAL

Placebo once daily (12 weeks), Vilaprisan 2 mg once daily (12 weeks)

Drug: Vilaprisan (BAY1002670

Arm 3 - BAY1002670 + BAY1002670

EXPERIMENTAL

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

Drug: Vilaprisan (BAY1002670

Arm 4 - Placebo+BAY1002670

EXPERIMENTAL

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

Drug: Vilaprisan (BAY1002670)

Arm 5 - Ulipristal + Ulipristal

ACTIVE COMPARATOR

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

Drug: Ulipristal

Arm 6- Placebo + Ulipristal

ACTIVE COMPARATOR

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

Drug: Ulipristal

Arm 7- Ulipristal + Placebo

ACTIVE COMPARATOR

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

Drug: Ulipristal

Interventions

Vilaprisan (BAY1002670) DRUG

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

Arm 1 - BAY1002670 + BAY1002670

Ulipristal DRUG

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

Arm 5 - Ulipristal + Ulipristal

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (64)

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Villach, Carinthia, 9500, Austria

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Graz, Styria, 8036, Austria

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Innsbruck, Tyrol, 6020, Austria

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Vienna, Vienna, 1090, Austria

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Tienen, Vlaams Brabant, 3300, Belgium

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Bruxelles - Brussel, 1000, Belgium

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Edegem, 2650, Belgium

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Pleven, 5800, Bulgaria

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Sofia, 1504, Bulgaria

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Sofia, 1606, Bulgaria

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Stara Zagora, 6000, Bulgaria

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Brno, 625 00, Czechia

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České Budějovice, 37001, Czechia

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Olomouc, 772 00, Czechia

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Olomouc, 775 20, Czechia

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Pilsen, 30708, Czechia

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Písek, 39701, Czechia

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Prague, 120 00, Czechia

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Prague, 13000, Czechia

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Prague, 180 81, Czechia

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Helsinki, 00610, Finland

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Pori, 28500, Finland

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Turku, 20100, Finland

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Dresden, Saxony, 01307, Germany

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Bernburg, Saxony-Anhalt, 06406, Germany

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Blankenburg, Saxony-Anhalt, 38889, Germany

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Berlin, State of Berlin, 10787, Germany

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Budapest, 1036, Hungary

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Debrecen, 4024, Hungary

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Debrecen, 4032, Hungary

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Szentes, H-6600, Hungary

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Modena, Emilia-Romagna, 41124, Italy

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Cagliari, Sardinia, 09042, Italy

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Catania, Sicily, 95123, Italy

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Vilnius, LT-05263, Lithuania

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Vilnius, LT-08217, Lithuania

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Vilnius, LT-10207, Lithuania

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Almere Stad, 1315 RA, Netherlands

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Heerlen, 6419 PC, Netherlands

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Nieuwegein, 3435 CM, Netherlands

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Zwolle, 8025 AB, Netherlands

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Fredrikstad, 1605, Norway

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Lørenskog, 1478, Norway

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Nesttun, 5221, Norway

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Stavanger, 4011, Norway

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Bialystok, 15- 224, Poland

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Lodz, 90-602, Poland

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Lublin, 20-093, Poland

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Lublin, 20-632, Poland

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Warsaw, 02-507, Poland

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Coimbra, Coimbra District, 3000-075, Portugal

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Lisbon, Lisbon District, 1449-005, Portugal

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Porto, Porto District, 4202-451, Portugal

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Barcelona, Barcelona, 08003, Spain

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Aravaca, Madrid, 28023, Spain

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Valencia, Valencia, 46010, Spain

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Valencia, Valencia, 46026, Spain

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Stockholm, 118 83, Sweden

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Stockholm, 171 76, Sweden

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Umeå, 90185, Sweden

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Harrow, London, HA1 3UJ, United Kingdom

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London, N19 5NF, United Kingdom

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Nottingham, NG7 2UH, United Kingdom

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Portsmouth, PO6 3LY, United Kingdom

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Related Publications (1)

• 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.

  PMID: 32559602 DERIVED

MeSH Terms

Conditions

Leiomyoma; Menorrhagia

Interventions

vilaprisan; ulipristal

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: June 9, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 22, 2016

Record last verified: 2016-11

Locations

SE (3); IT (3); AU (4); BU (4); BE (3); DE (4); LI (3); PL (5); HU (4); PT (3); GB (4); ES (4); NL (4); FI (3); NO (4); CZ (9)