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

NCT02131662 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 157882013-003945-40
• Study Type: interventional
• Target: 309
• Locations: 13 countries
• Sites: 105

Brief 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. To assess the efficacy of BAY1002670 the interchangeability of menstrual pictogram and alkaline hematin method for the judgement of menstrual blood loss will be assessed.

Conditions

Leiomyoma

Keywords

Uterine fibroids

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  From baseline to end of follow-up

• Time to Onset of Controlled Bleeding

  During treatment period

• Change in Volume of Largest Fibroid Compared to Baseline Measured by MRI

  From baseline to end of follow-up period

Other Outcomes (9)

• Exposure-response Analysis of Vilaprisan - Percentage of Subjects Achieving Maximum Effect (Emax) of Induced Amenorrhea

  From start of the study treatment to Day 84 (treatment period)

• Steady-state Exposure Achieving Half-maximal Effect (EAUC50) of Induced Amenorrhea During Treatment Period of Vilaprisan

  From start of the study treatment to Day 84 (treatment period)

• Exposure-response Analysis of Vilaprisan - Predicted Percentage of Subjects Below 90% of the Maximum Probability of Induced Amenorrhea

  From start of the study treatment to Day 84 (treatment period)

Study Arms (5)

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

Interventions

BAY1002670 DRUG

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.

VPR 4 mg

Placebo DRUG

Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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
• 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)

You may not qualify if:

• Pregnancy or lactation
• Uterine fibroid with largest diameter \>10.0 cm
• Hypersensitivity to any ingredient of the study drug
• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (105)

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Mesa, Arizona, 85209, United States

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Tucson, Arizona, 85712, United States

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San Diego, California, 92103, United States

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San Diego, California, 92108, United States

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Denver, Colorado, 80209, United States

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Southington, Connecticut, 06489, United States

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Washington D.C., District of Columbia, 20036, United States

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Gainesville, Florida, 32606, United States

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Jacksonville, Florida, 32207, United States

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Plantation, Florida, 33324, United States

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South Miami, Florida, 33143, United States

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Sandy Springs, Georgia, 30328, United States

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Naperville, Illinois, 60540, United States

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Newburgh, Indiana, 47630, United States

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Marrero, Louisiana, 70072, United States

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Lincoln, Nebraska, 68510, United States

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Moorestown, New Jersey, 08057, United States

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Neptune City, New Jersey, 07753, United States

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New Brunswick, New Jersey, 08901, United States

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New York, New York, 10038, United States

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Durham, North Carolina, 27713, United States

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Raleigh, North Carolina, 27612, United States

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Cleveland, Ohio, 44195, United States

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Columbus, Ohio, 43231, United States

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Portland, Oregon, 97239-3011, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19114, United States

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Pittsburgh, Pennsylvania, 15206, United States

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Pittsburgh, Pennsylvania, 15213-3180, United States

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Chattanooga, Tennessee, 37404, United States

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Dallas, Texas, 75231, United States

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Frisco, Texas, 75035, United States

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Houston, Texas, 77030, United States

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Houston, Texas, 77054, United States

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Norfolk, Virginia, 23507, United States

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Seattle, Washington, 98105, United States

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Bruxelles - Brussel, 1070, Belgium

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Bruxelles - Brussel, 1200, Belgium

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Charleroi, 6000, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, 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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Sofia, 1797, Bulgaria

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Stara Zagora, 6000, Bulgaria

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Winnipeg, Manitoba, R3T 2E8, Canada

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Hamilton, Ontario, L8S 4K1, Canada

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Ottawa, Ontario, K1H 7W9, Canada

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Pointe-Claire, Quebec, H9R 4S3, Canada

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Québec, G1S 2L6, Canada

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České Budějovice, 370 01, Czechia

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Hradec Králové, 500 05, Czechia

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Olomouc, 772 00, Czechia

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Písek, 39701, Czechia

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Prague, 12808, Czechia

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Prague, 13000, Czechia

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Espoo, 02100, Finland

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Helsinki, 00260, Finland

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Joensuu, 80100, Finland

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Kuopio, 70110, Finland

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Oulu, 90100, Finland

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Karlsruhe, Baden-Wurttemberg, 76199, Germany

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Erlangen, Bavaria, 91054, Germany

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Geseke, North Rhine-Westphalia, 59590, Germany

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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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Lübeck, Schleswig-Holstein, 23538, Germany

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Berlin, 12200, Germany

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Ilsede, 31241, Germany

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Debrecen, 4024, Hungary

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Debrecen, 4032, Hungary

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Kecskemét, 6000, Hungary

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Szeged, 6725, Hungary

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Szentes, 6600, Hungary

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Matsudo, Chiba, 270-2267, Japan

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Iizuka, Fukuoka, 820-8505, Japan

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Kōriyama, Fukushima, 963-8585, Japan

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Sapporo, Hokkaido, 004-0052, Japan

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Sapporo, Hokkaido, 064-0808, Japan

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Kanazawa, Ishikawa-ken, 920-8530, Japan

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Ōmura, Nagasaki, 856-8562, Japan

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Numazu, Shizuoka, 410-8555, Japan

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Kita-ku, Tokyo, 115-0053, Japan

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Nakano-ku, Tokyo, 164-8541, Japan

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Tacchikawa, Tokyo, 190-8531, Japan

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Kumamoto, 862-8505, Japan

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Nagano, 381-8551, Japan

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Nesttun, 5221, Norway

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Oslo, 0407, Norway

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Sellebakk, 1653, Norway

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Trondheim, 7006, Norway

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Trondheim, 7014, Norway

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Aravaca, Madrid, 28023, Spain

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Barcelona, 08028, Spain

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Barcelona, 08035, Spain

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Seville, 41013, Spain

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Seville, 41014, Spain

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Valencia, 46017, Spain

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Gothenburg, 411 18, Sweden

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Örebro, 701 85, Sweden

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Stockholm, 171 76, Sweden

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Uppsala, 751 85, Sweden

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Bern, 3010, Switzerland

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Related Publications (2)

• 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.

  PMID: 30682081 DERIVED

• 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.

  PMID: 30527839 DERIVED

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

MeSH Terms

Conditions

Leiomyoma

Interventions

vilaprisan

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayer.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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 5, 2014
• First Posted: May 6, 2014
• Study Start: May 15, 2014
• Primary Completion: May 4, 2016
• Study Completion: May 4, 2016
• Last Updated: December 8, 2017
• Results First Posted: December 8, 2017

Record last verified: 2017-11

Locations

HU (5); NO (5); ES (6); SE (4); CH (1); JP (13); BE (5); FI (5); BU (5); US (36); CA (5); CZ (6); DE (9)