Back to resultsBay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap (ASTEROID 1)
Primary Purpose
Leiomyoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BAY1002670
BAY1002670
BAY1002670
BAY1002670
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Leiomyoma focused on measuring Uterine fibroids
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
VPR 4 mg
VPR 2 mg
VPR 1 mg
VPR 0.5 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02131662
Brief Title
Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap
Acronym
ASTEROID 1
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 15, 2014 (Actual)
Primary Completion Date
May 4, 2016 (Actual)
Study Completion Date
May 4, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyoma
Keywords
Uterine fibroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
309 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VPR 4 mg
Arm Type
Experimental
Arm Title
VPR 2 mg
Arm Type
Experimental
Arm Title
VPR 1 mg
Arm Type
Experimental
Arm Title
VPR 0.5 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BAY1002670
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
BAY1002670
Intervention Description
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Intervention Type
Drug
Intervention Name(s)
BAY1002670
Intervention Description
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Intervention Type
Drug
Intervention Name(s)
BAY1002670
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
After end of the initial bleeding episode until the end of treatment, up to 12 weeks
Secondary Outcome Measure Information:
Title
Change in Volume of Menstrual Blood Loss Per 28 Days From Baseline During Treatment by Reference Period (Assessed by Alkaline Hematin Method)
Description
In the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint for each arm, respectively.
Time Frame
From baseline to end of follow-up
Title
Time to Onset of Controlled Bleeding
Description
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.
Time Frame
During treatment period
Title
Change in Volume of Largest Fibroid Compared to Baseline Measured by MRI
Description
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).
Time Frame
From baseline to end of follow-up period
Other Pre-specified Outcome Measures:
Title
Exposure-response Analysis of Vilaprisan - Percentage of Subjects Achieving Maximum Effect (Emax) of Induced Amenorrhea
Description
Maximum effect of vilaprisan on induced amenorrhea during treatment period. Induced amenorrhea was defined as number of subjects with amenorrhea (that is, all days with bleeding intensity 1 = none) , i.e. no bleeding or spotting allowed after initial bleeding episode until end of treatment. The nature of this exposure response analysis was the development of a model valid for the exposure response relationship over the entire range of available exposures (i.e. across all dose groups). Therefore, observations (exposure - induced amenorrhea) of all subjects need to be combined.
Time Frame
From start of the study treatment to Day 84 (treatment period)
Title
Steady-state Exposure Achieving Half-maximal Effect (EAUC50) of Induced Amenorrhea During Treatment Period of Vilaprisan
Description
Area-under-the-curve (AUC) of vilaprisan between 0 and 24 hours post-dose at steady-state achieving 50% of maximum effect of vilaprisan on induced amenorrhea during treatment period. Induced amenorrhea was defined as number of subjects with induced-amenorrhea (that is, all days with bleeding intensity 1 = none) , i.e. no bleeding or spotting allowed after initial bleeding episode until end of treatment. The nature of this exposure response analysis was the development of a model valid for the exposure response relationship over the entire range of available exposures (i.e. across all dose groups). Therefore, observations (exposure - induced amenorrhea) of all subjects need to be combined.
Time Frame
From start of the study treatment to Day 84 (treatment period)
Title
Exposure-response Analysis of Vilaprisan - Predicted Percentage of Subjects Below 90% of the Maximum Probability of Induced Amenorrhea
Description
The final exposure-response model was used to simulate the percentage of subjects below 90% of the maximum probability of induced amenorrhea (that is, all days with bleeding intensity 1 = none) for the selected doses 1, 2 and 3 mg (see table below).
Time Frame
From start of the study treatment to Day 84 (treatment period)
Title
Assessment of MP to Identify Subjects With Heavy Menstrual Bleeding (HMB)
Description
The ability of the MP to identify subjects with HMB (defined as > 80 mL of blood loss during bleeding episode) per 28 days against the the current gold standard (i.e. AH method) was assessed. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of MP method for detecting heavy menstrual bleeding were calculated against AH method. Sensitivity = true positive/(true positive + false negative)*100; Specificity = true negative/(true negative + false positive)*100; PPV = true positive/(true positive + false positive)*100; NPV = true negative/(true negative + false negative)*100. MP version 2014 was originally defined based on studies in healthy subjects. And MP version 2016 was developed for study population of women with heavy bleeding.
Time Frame
At baseline
Title
Percentage of Subjects With Amenorrhea (Defined as MBL < 2 mL) During the Last 28 Days of Treatment
Time Frame
Last 28 Days of Treatment
Title
Percentage of Subjects With HMB Response During the Last 28 Days of Treatment
Time Frame
Last 28 Days of Treatment
Title
Estimated Dose-response Curve Based on Amenorrhea - E0 and Emax
Description
The primary objective was to estimate the dose-response curve based on the primary endpoint: subjects with amenorrhea. The number of subjects with amenorrhea was assumed to be binomial distributed. A 4 parameters logistic model was used to fit the observed data for characterizing the dose-response curve: E0, Emax, ED50 and δ. The model is defined as p(d)=E0 + Emax/{1+ e^[{ED50-d)/δ]}. E0 is the amenorrhea rate for placebo; Emax is the maximum effect attributable to the drug (compared with the basal effect with dose at d=0 [placebo group], the maximum increase of drug effect).
Time Frame
After end of the initial bleeding episode until the end of treatment
Title
Estimated Dose-response Curve Based on Amenorrhea - ED50
Description
The primary objective was to estimate the dose-response curve based on the primary endpoint: subjects with amenorrhea. The number of subjects with amenorrhea was assumed to be binomial distributed. A 4 parameters logistic model was used to fit the observed data for characterizing the dose-response curve: E0, Emax, ED50 and δ. The model is defined as p(d)=E0 + Emax/{1+ e^[{ED50-d)/δ]}. ED50 is the dose at which 50% of Emax were achieved.
Time Frame
After end of the initial bleeding episode until the end of treatment
Title
Estimated Dose-response Curve Based on Amenorrhea - δ
Description
The primary objective was to estimate the dose-response curve based on the primary endpoint: subjects with amenorrhea. The number of subjects with amenorrhea was assumed to be binomial distributed. A 4 parameters logistic model was used to fit the observed data for characterizing the dose-response curve: E0, Emax, ED50 and δ. The model is defined as p(d)=E0 + Emax/{1+ e^[{ED50-d)/δ]}. δ is hill slope parameter which measures sensitivity of the response to the dose range of the drug, determining the steepness of the dose-response curve.
Time Frame
After end of the initial bleeding episode until the end of treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85209
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
City
Southington
State/Province
Connecticut
ZIP/Postal Code
06489
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
City
Neptune City
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10038
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43231
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3011
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-3180
Country
United States
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Frisco
State/Province
Texas
ZIP/Postal Code
75035
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
City
Bruxelles - Brussel
ZIP/Postal Code
1070
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1200
Country
Belgium
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Liege
ZIP/Postal Code
4000
Country
Belgium
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1504
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 2E8
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 7W9
Country
Canada
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
City
Quebec
ZIP/Postal Code
G1S 2L6
Country
Canada
City
Ceske Budejovice
ZIP/Postal Code
370 01
Country
Czechia
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
City
Olomouc
ZIP/Postal Code
772 00
Country
Czechia
City
Pisek
ZIP/Postal Code
39701
Country
Czechia
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
City
Praha
ZIP/Postal Code
13000
Country
Czechia
City
Espoo
ZIP/Postal Code
02100
Country
Finland
City
Helsinki
ZIP/Postal Code
00260
Country
Finland
City
Joensuu
ZIP/Postal Code
80100
Country
Finland
City
Kuopio
ZIP/Postal Code
70110
Country
Finland
City
Oulu
ZIP/Postal Code
90100
Country
Finland
City
Karlsruhe
State/Province
Baden-Württemberg
ZIP/Postal Code
76199
Country
Germany
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
City
Geseke
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
59590
Country
Germany
City
Bernburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06406
Country
Germany
City
Blankenburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
38889
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
City
Berlin
ZIP/Postal Code
12200
Country
Germany
City
Ilsede
ZIP/Postal Code
31241
Country
Germany
City
Debrecen
ZIP/Postal Code
4024
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
City
Matsudo
State/Province
Chiba
ZIP/Postal Code
270-2267
Country
Japan
City
Iizuka
State/Province
Fukuoka
ZIP/Postal Code
820-8505
Country
Japan
City
Koriyama
State/Province
Fukushima
ZIP/Postal Code
963-8585
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
004-0052
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
064-0808
Country
Japan
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8530
Country
Japan
City
Omura
State/Province
Nagasaki
ZIP/Postal Code
856-8562
Country
Japan
City
Numazu
State/Province
Shizuoka
ZIP/Postal Code
410-8555
Country
Japan
City
Kita
State/Province
Tokyo
ZIP/Postal Code
115-0053
Country
Japan
City
Nakano-ku
State/Province
Tokyo
ZIP/Postal Code
164-8541
Country
Japan
City
Tacchikawa
State/Province
Tokyo
ZIP/Postal Code
190-8531
Country
Japan
City
Kumamoto
ZIP/Postal Code
862-8505
Country
Japan
City
Nagano
ZIP/Postal Code
381-8551
Country
Japan
City
Nesttun
ZIP/Postal Code
5221
Country
Norway
City
Oslo
ZIP/Postal Code
0407
Country
Norway
City
Sellebakk
ZIP/Postal Code
1653
Country
Norway
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
City
Trondheim
ZIP/Postal Code
7014
Country
Norway
City
Aravaca
State/Province
Madrid
ZIP/Postal Code
28023
Country
Spain
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
City
Valencia
ZIP/Postal Code
46017
Country
Spain
City
Göteborg
ZIP/Postal Code
411 18
Country
Sweden
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
30682081
Citation
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.
Results Reference
derived
PubMed Identifier
30527839
Citation
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.
Results Reference
derived
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Learn more about this trial
Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap
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