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ASTEROID 5: Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT03240523
Collaborator
(none)
766
Enrollment
140
Locations
3
Arms
50.8
Actual Duration (Months)
5.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to describe the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal.

The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vilaprisan (BAY1002670)
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
766 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
With protocol version 5.0 the blinded study arms A3 and B were converted to one open-label study arm called A3/B.
Primary Purpose:
Treatment
Official Title:
A Randomized, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids
Actual Study Start Date :
Jul 31, 2017
Actual Primary Completion Date :
Jun 28, 2020
Actual Study Completion Date :
Oct 25, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A1: Vilaprisan (3/1 regimen)

Orally, 2 mg, once daily, 3 months treatment followed by 1 menstrual bleeding episode

Drug: Vilaprisan (BAY1002670)
Orally, 2 mg, once daily
Experimental: Group A2: Vilaprisan (6/2 regimen)

Orally, 2 mg, once daily, 6 months treatment followed by 2 menstrual bleeding episodes

Drug: Vilaprisan (BAY1002670)
Orally, 2 mg, once daily
Experimental: Group A3/B (3/2 regimen)

Orally, 2 mg, once daily, 3 months treatment followed by 2 menstrual bleeding episodes With protocol version 5.0 the blinded study arms A3 and B were converted to one open-label study arm called A3/B.

Drug: Vilaprisan (BAY1002670)
Orally, 2 mg, once daily

Outcome Measures

Primary Outcome Measures

  1. Amenorrhea (yes/no) [At 3 months (at the end of treatment perid 1)]

    Defined as menstrual blood loss (MBL) < 2 mL based on the menstrual pictogram (MP) during last 28 days. For the primary analysis of the primary variable, the amenorrhea rates after 12 weeks of treatment in Groups A1, A2 and A3 will be compared to the rate from Group B.

Secondary Outcome Measures

  1. Total volume of menstrual blood loss [After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2]

    Assessed by menstrual pictogram (MP). Volume of menstrual blood loss will be normalized by 28 days.

  2. Number of bleeding days [After approximately 1 year in subgroup 1 and after approximately 2 years in subgroup 2]

    From day 1 of the first treatment period until the day before the next treatment period after the last treatment period would start again normalized to 28 days.

  3. Amenorrhea (yes/no) [At 6 months, at 12 months, at 15 months, at 18 months, at 21 months and at 24 months]

    Defined as menstrual blood loss (MBL) < 2 mL based on the menstrual pictogram (MP) during last 28 days of the treatment period.

  4. Absence of bleeding (spotting allowed) [Up to 24 months]

    Absence of bleeding defined as no bleeding (spotting allowed) during the last 28 days of the treatment; based on the UF-DBD (Uterine Fibroid Daily Symptom Diary).

  5. Time to onset of controlled bleeding [Quarterly up to 24 months]

    Onset of controlled bleeding is defined by the first day, for which the menstrual blood loss (assessed by MP) for all subsequent 28-day periods up to the end of the treatment period is less than 80.00 mL.

  6. HMB (Heavy Menstrual Bleeding) responder rate [By treatment period up to 24 months]

    Percentage of subjects with blood loss < 80.00 mL per 28 days and 50% reduction compared to baseline [assessed by MP]

  7. Percent change in volume of largest fibroid compared to baseline [At baseline, at 12 months and at 24 months]

    Measured by MRI (magnetic resonance imaging).

  8. Endometrial histology [Up to 24 months]

    E.g., benign endometrium, presence or absence of hyperplasia or malignancy

  9. Endometrial thickness [Up to 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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 more than 30 mm and less than 120 mm

  • Heavy menstrual bleeding (HMB) >80.00 mL documented by menstrual pictogram (MP) in a bleeding episode period during the screening period

  • 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

Exclusion Criteria:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Paratus Clinical Pty Ltd Blacktown New South Wales Australia 2148
2 Paratus Clinical Wyong Complex Kanwal New South Wales Australia 2259
3 Women's Health and Research Institute of Australia-WHRIA Sydney New South Wales Australia 2000
4 Greenslopes Private Hospital Greenslopes Queensland Australia 4120
5 Medizinische Universität Graz Graz Steiermark Austria 8036
6 Landeskrankenhaus Bregenz Bregenz Vorarlberg Austria 6900
7 Universitätsklinikum AKH Wien Wien Austria 1090
8 AZ Jan Palfijn Gent Gent Oost-Vlaanderen Belgium 9000
9 CHU Saint-Pierre/UMC Sint-Pieter Bruxelles - Brussel Belgium 1000
10 CU Saint-Luc/UZ St-Luc Bruxelles - Brussel Belgium 1200
11 CHU de Tivoli La Louviere Belgium 7100
12 CHR de la Citadelle Liege Belgium 4000
13 Femicare vzw Tienen Belgium 3300
14 MHAT Blagoevgrad AD Blagoevgrad Bulgaria 2700
15 MHAT Dobrich Dobrich Bulgaria 9300
16 MC Asklepii OOD Dupnitsa Bulgaria 2600
17 Multiprofile Hospital for Active Treatment Uni Hospital OOD Panagyurishte Bulgaria 4500
18 MHAT Avis Medika Pleven Bulgaria 5800
19 pecialized Hosp for Act Trm of oncology disord Sofia Region Sofia Bulgaria 1000
20 DCC Aleksandrovska Sofia Bulgaria 1606
21 Medical Center Panaceya Sofia Bulgaria 1606
22 MHAT Niamed Stara Zagora Bulgaria 6000
23 Multiprofile Hospital for Active Treatment Sv. Anna Varna Bulgaria 9000
24 SHOGAT Prof Dimitar Stamatov Varna Bulgaria 9000
25 Ocean West Research Clinic Inc Surrey British Columbia Canada V3S 2N6
26 Strand Clinic St. John's Newfoundland and Labrador Canada A1A 4Y3
27 Ottawa Hospital-Riverside Campus Ottawa Ontario Canada K1H 7W9
28 Clinique OVO Montreal Quebec Canada H4P 2S4
29 Clinique Recherche en Sante des Femmes Inc. Quebec Canada G1S 2L6
30 Centre de recherche Saint-Louis Quebec Canada G1W 4R4
31 ALPHA Recherche Clinique Quebec Canada G3K 2P8
32 Fakultni Nemocnice Brno Brno Czechia 625 00
33 Gynekologicka ordinace Ceske Budejovice Czechia 370 01
34 G-Centrum Olomouc s.r.o. Dr. Skrivanek Olomouc Czechia 772 00
35 Centrum gynekologicke rehabilitace Pisek Czechia 39701
36 MUDr. Martina Maresova Rosenbergova, gynekologie Plzen Czechia 300 01
37 Dr. Smrhova-Kovacs Tabor Czechia 39003
38 MediGyn s.r.o. Trebon Czechia 379 01
39 GYNEKO spol. s r.o. Vsetin Czechia 755 01
40 Aarhus Universitetshospital, Skejby Aarhus N Denmark 8200
41 Nordsjælland Hospital Hillerød Hillerød Denmark 3400
42 Hvidovre Hospital Hvidovre Denmark 2650
43 Odense Universitetshospital Odense C Denmark DK-5000
44 HUS / Naistenklinikka Helsinki Finland 00029
45 VL-Medi Oy Helsinki Finland 00510
46 Kymenlaakson keskussairaala Kotka Finland 48210
47 Lääkäriasema Cantti Oy Kuopio Finland 70110
48 Lääkärikeskus Gyneko Oulu Finland 90100
49 Turun yliopistollinen keskussairaala, kantasairaala Turku Finland 20520
50 Praxisklinik am Rosengarten Mannheim Baden-Württemberg Germany 68165
51 Frauenarztpraxis Dr. Wolfgang Clemens Stolberg Nordrhein-Westfalen Germany 52222
52 Praxis f. Gynäkologie und Geburtshilfe Bernburg Sachsen-Anhalt Germany 06406
53 emovis GmbH Berlin Germany 10629
54 Principal SMO Kft. Baja Hungary 6500
55 Dr. Rethy Pal Korhaz - Rendelointezet Bekescsaba Bekescsaba Hungary 5600
56 Robert Karoly Magankorhaz Budapest Hungary 1135
57 Szent Anna szuleszeti-nogyogyaszati maganrendelo Debrecen Hungary 4024
58 NAP - Rendelo, Private Clinic Debrecen Hungary 4028
59 Debreceni Egyetem Klinikai Kozpont Debrecen Hungary 4032
60 Komaromi Selye Janos Korhaz Komarom Hungary 2900
61 SzSzBMK es EOK Josa Andras Oktatokorhaz Nyiregyhaza Hungary 4400
62 SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont Szeged Hungary 6725
63 Midland Regional Hospital Mullingar Westmeath Ireland
64 A.O.U. Policlinico - Vittorio Emanuele Catania Sicilia Italy 95123
65 A.O. Ospedali Riuniti Villa Sofia-Cervello Palermo Sicilia Italy 90146
66 A.O.U. Careggi Firenze Toscana Italy 50134
67 A.O.U.I. Verona Verona Veneto Italy 37126
68 Dongguk University Hospital Goyang-si Gyeonggido Korea, Republic of 10326
69 Seoul National University Bundang Hospital Seongnam-si Gyeonggido Korea, Republic of 463-707
70 Ajou University Hospital Suwon Gyeonggido Korea, Republic of 443-721
71 Inje University Haeundae Paik Hospital Busan Korea, Republic of 612-862
72 Keimyung University Dongsan Medical Center Daegu Korea, Republic of 700-712
73 Seoul National University Hospital Seoul Korea, Republic of 03080
74 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
75 Asan Medical Center Seoul Korea, Republic of 05505
76 Kangnam Sacred Heart Hospital Seoul Korea, Republic of 07441
77 CHA Gangnam Medical Center Seoul Korea, Republic of 135-081
78 The Catholic University of Korea Seoul St. Mary's Hospital Seoul Korea, Republic of 137-701
79 Korea University Guro Hospital Seoul Korea, Republic of 152-703
80 Ewha Womans University Hospital Seoul Korea, Republic of 158-710
81 Jsc "Vakk" Kaunas Lithuania LT-51028
82 Klaipeda City Outpatient Clinic Klaipeda Lithuania LT-93200
83 JSC Seimos gydytojas family medical center Vilnius Lithuania LT-01118
84 JSC Gyvenk Silciau Medical Center Maxmeda Vilnius Lithuania LT-03225
85 Private hospital and outpatient clinic "Kardiolita" Vilnius Lithuania LT-05263
86 Vilnius University Hospital Santaros Klinikos Vilnius Lithuania LT-08661
87 Flevoziekenhuis Almere Netherlands 1315 RA
88 VUmc Amsterdam Netherlands 1081 HV
89 Maasstad Ziekenhuis Rotterdam Netherlands 3079 DZ
90 Kirkeparken Spesialistpraksis Fredrikstad Norway 1605
91 Nesttun Spesialistpraksis AS Nesttun Norway 5221
92 Medicus Oslo AS Oslo Norway 0161
93 Stavanger Universitetssjukehus Stavanger Norway 4011
94 Medicus AS Trondheim Norway 7014
95 Tomaszewski Medical Center Bialystok Poland 15-084
96 Prywatna Klinika Ginekologiczno-Poloznicza Bialystok Poland 15-244
97 CLINICAL MEDICAL RESEARCH Sp. z o. o. Katowice Poland 40-156
98 Vita Longa Sp. z o.o. Katowice Poland 40-748
99 Medico Praktyka Lekarska Krakow Poland 31-315
100 Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr. Lodz Poland 90-602
101 Centrum Medyczne Chodzki Lublin Poland 20-093
102 Specjalistyczny Gabinet Ginekologiczno-Polozniczy Lublin Poland 20-400
103 NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie S.C Lublin Poland 20-632
104 VitroLive Sp. z o.o. Szczecin Poland 70-483
105 NZOZ Zieniewicz Medical Warszawa Poland 02-201
106 Centrum Badawcze Wspolczesnej Terapii Warszawa Poland 02-679
107 Hospital de Braga Braga Portugal 4710-243
108 CHUC - Hospitais da Universidade de Coimbra Coimbra Portugal 3000-075
109 CHLO - Hospital Sao Francisco Xavier Lisboa Portugal 1449-005
110 Univerzitna nemocnica Bratislava, Nemocnica Ruzinov Bratislava 2 Slovakia 826 06
111 ULMUS, s r.o. Hlohovec Slovakia 920 01
112 GA Lucenec s.r.o Lucenec Slovakia 984 01
113 GYNEMMA s.r.o. Malacky Slovakia 901 01
114 Galipea s.r.o. Nitra Slovakia 949 01
115 Gyncentrum Nitra s.r.o. Nitra Slovakia 949 01
116 Virina sano, s.r.o. Gynekologicko porodnicka ambulancia Velky Krtis Slovakia 990 01
117 Hospital Sanitas La Zarzuela Aravaca Madrid Spain 28023
118 Hospital de Basurto Bilbao Vizcaya Spain 48013
119 Hospital Universitario 12 de Octubre Madrid Spain 28041
120 Ginemed Sevilla Spain 41010
121 Hospital Universitario Virgen del Rocío Sevilla Spain 41013
122 Hospital General Universitario de Valencia Valencia Spain 46014
123 Hospital Universitario de Álava - Sede Txagorritxu Vitoria Álava Spain 01009
124 Södersjukhuset AB Stockholm Sweden 118 83
125 Karolinska Universitetssjukhuset i Solna Stockholm Sweden 171 76
126 Danderyds sjukhus Stockholm Sweden 182 88
127 Akademiska Sjukhuset Uppsala Sweden 75185
128 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan 80756
129 China Medical University Hospital Taichung Taiwan 40447
130 Taichung Veterans General Hospital Taichung Taiwan 40705
131 National Cheng Kung University Hospital Tainan Taiwan 704
132 National Taiwan University Hospital Taipei Taiwan 10016
133 Mackay Memorial Hospital Taipei Taiwan 10449
134 Taipei Veterans General Hospital Taipei Taiwan 11217
135 Chang Gung Memorial Hospital at Linkou Taoyuan Taiwan 333423
136 North Hampshire Hospital Basingstoke Hampshire United Kingdom RG24 9NA
137 North Middlesex University Hospital London United Kingdom N18 1QX
138 Whittington Hospital London United Kingdom N19 5NF
139 Chelsea & Westminster Hospital London United Kingdom SW10 9NH
140 St Mary's Hospital (London) London United Kingdom W2 1NY

Sponsors and Collaborators

  • Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT03240523
Other Study ID Numbers:
  • 15789
  • 2016-002855-48
First Posted:
Aug 7, 2017
Last Update Posted:
Nov 1, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Leiomyoma
Myofibroma

Study Results

No Results Posted as of Nov 1, 2021