chufangao/CTO huggingface dataset:
Clinical trial NCT04444830: Sprix for Postoperative Pain Control Following Gynecologic Surgery
Official title: Can Intranasal Ketorolac Tromethamine Prescribed Postoperatively After Major Female Pelvic Reconstructive Surgery Reduce Consumption of Prescribed Narcotics?
Sponsor: University of Louisville (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Study never opened to enrollment. Study never IRB approved.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-31
Primary completion date: 2021-09-21
Completion date: 2021-09-21
Plan to share individual participant data: NO
Clinical trial NCT04167462: An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo in Participants With Plaque Psoriasis (POETYK-PSO-3) in Mainland China, Taiwan, and South Korea
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis
Acronym: POETYK-PSO-3
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 220.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-25
Primary completion date: 2021-03-08
Completion date: 2022-01-07
Clinical trial NCT03012581: Secured Access to Nivolumab for Adult Patients With Selected Rare Cancer Types
Official title: Secured Access to Nivolumab for Adult Patients With Selected Rare Cancer Types
Acronym: AcSé
Sponsor: UNICANCER (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 269.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-06-16
Primary completion date: 2022-12-22
Completion date: 2023-11-11
Plan to share individual participant data: NO
Clinical trial NCT02032784: Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding
Official title: Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding
Sponsor: AdventHealth (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Difficult to enroll subjects
Enrollment: 33.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-03-31
Primary completion date: 2018-06-28
Completion date: 2020-07-06
Plan to share individual participant data: NO
Clinical trial NCT05064800: PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants
Official title: A PHASE 1, OPEN-LABEL, 3-TREATMENT, 6-SEQUENCE, 3-PERIOD CROSSOVER STUDY TO ESTIMATE THE EFFECT OF PF-07321332/RITONAVIR AND RITONAVIR ON THE PHARMACOKINETICS OF DABIGATRAN IN HEALTHY PARTICIPANTS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 24.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-09-21
Primary completion date: 2021-12-06
Completion date: 2021-12-06
Baseline population: All participants who were enrolled in the study.
Plan to share individual participant data: NO
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT02047318: An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS)
Official title: A Multicentre Extension Study to Evaluate the Long-Term Safety and Durability of the Therapeutic Effect of LUM001 Also Known as Maralixibat (MRX), an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome
Acronym: IMAGINE
Sponsor: Mirum Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 19.0 (ACTUAL)
Number of arms: 1.0
Start date: 2013-12-20
Primary completion date: 2020-06-17
Completion date: 2020-06-17
Baseline population: After a short dose escalation period, participants received MRX 280 ug/kg/day, which consisted of most of their exposure within the study. As such, summaries are presented as a single arm, MRX.
Limitations and caveats: Limitations of the trial such as small numbers of subjects analyzed or technical problems leading to unreliable data.
Clinical trial NCT05347147: A Trial to Determine the Efficacy and Safety of Presendin in IIH
Official title: A Phase III Randomised, Placebo-controlled, Double-blind, Multi-centre, Clinical Trial to Determine the Efficacy and Safety of Presendin in Idiopathic Intracranial Hypertension
Acronym: IIH EVOLVE
Sponsor: Invex Therapeutics Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Following a strategic evaluation of its IIH EVOLVE Phase III clinical trial investigating Presendin™, the Invex Board has made the difficult decision that the continuation of the trial is not viable and therefore the trial has been terminated.
Enrollment: 14.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-11-18
Primary completion date: 2023-09-18
Completion date: 2023-10-20
Limitations and caveats: Due to the early termination of the study, planned analyses were not fully conducted but were restricted to the most relevant safety endpoints as per the abbreviated SAP v1. Outcome measure (efficacy) data are raw data from individual subjects, with minimal analysis; e.g., where an outcome measure specified change from baseline to Week 24, baseline and Week 24 values are presented. Efficacy data were not subject to the same verification as safety data and no efficacy conclusions should be drawn.
Plan to share individual participant data: NO
Clinical trial NCT04839575: Study of Latiglutenase in T1D/CD Patients
Official title: Prospective, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Latiglutenase Treatment in Type 1 Diabetes Patients With Celiac Disease While Undergoing Periodic Gluten Exposure
Sponsor: Entero Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Covid-19 interruptions and enrollment challenges
Enrollment: 13.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-06
Primary completion date: 2022-12-19
Completion date: 2022-12-19
Plan to share individual participant data: NO
Clinical trial NCT04575597: Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)
Official title: A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Non-Hospitalized Adults With COVID-19.
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 1735.0 (ACTUAL)
Number of arms: 6.0
Start date: 2020-10-19
Primary completion date: 2022-05-05
Completion date: 2022-05-05
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04518995: Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1)
Official title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata (THRIVE-AA1)
Acronym: THRIVE-AA1
Sponsor: Concert Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 706.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-11-23
Primary completion date: 2022-04-19
Completion date: 2022-04-19
Baseline population: All randomized participants included all participants who were randomized in the study.
Plan to share individual participant data: NO
Clinical trial NCT04136444: A Pharmacokinetic Study of Padsevonil in Study Participants With Either Normal or Moderately Impaired Hepatic Function
Official title: An Open-Label, Parallel-Group, Pharmacokinetic Study of Padsevonil in Study Participants With Either Normal Hepatic Function or With Moderately Impaired Hepatic Function (Child-Pugh Class B)
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizures
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-28
Primary completion date: 2020-05-22
Completion date: 2020-05-22
Baseline population: Baseline Characteristics refer to the Safety Set (SS) which consisted of all study participants who received at least 1 dose of the investigational medicinal product (IMP).
Plan to share individual participant data: NO
IPD sharing description: Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
Clinical trial NCT04976257: Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion
Official title: Pharmacokinetic Comparison of Selective Prostatic Arterial and Intravenous PSMA Radioligand Infusions in Treatment-Naïve Prostate Cancer Patients
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-10-13
Primary completion date: 2023-03-22
Completion date: 2023-03-22
Plan to share individual participant data: NO
Clinical trial NCT04625972: Phase III Double-blind, Placebo-controlled Study of AZD7442 for Post- Exposure Prophylaxis of COVID-19 in Adults
Official title: A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Post-exposure Prophylaxis of COVID-19
Acronym: STORM CHASER
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1131.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-02
Primary completion date: 2021-04-07
Completion date: 2022-07-25
Baseline population: Full Analysis Set
Limitations and caveats: Results are reported for the Primary analysis conducted during the study.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Clinical trial NCT04705844: Study of Adalimumab or Placebo in Patients With Mild to Moderate COVID-19 (COMBAAT)
Official title: Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Adalimumab (Humira) or Placebo in Patients With Mild-Moderate COVID-19
Acronym: COMBAAT
Sponsor: Resilience Government Services, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: study withdrawn prior to screening subjects
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-30
Primary completion date: 2022-09-30
Completion date: 2022-09-30
Plan to share individual participant data: NO
Clinical trial NCT03355482: MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE
Official title: MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE
Acronym: MEASURE
Sponsor: Oklahoma Medical Research Foundation (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: poor recruitment, funding
Enrollment: 9.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-10
Primary completion date: 2022-02-16
Completion date: 2022-12-16
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03591770: Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib
Official title: The Immunogenicity and Safety of Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib
Sponsor: Boston Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Unable to recruit adequate numbers of participants to answer the research question.
Enrollment: 15.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-07-31
Primary completion date: 2024-07-04
Completion date: 2024-07-04
Plan to share individual participant data: NO
Clinical trial NCT03859973: This Study Tests Whether BI 425809 Together With Brain Training Using a Computer Improves Mental Functioning in Patients With Schizophrenia
Official title: A Phase II Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of BI 425809 Once Daily With Adjunctive Computerized Cognitive Training Over 12 Week Treatment Period in Patients With Schizophrenia
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 200.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-15
Primary completion date: 2022-09-30
Completion date: 2022-11-04
Baseline population: Treated Set (TS) includes all patients in randomized set (RS) who were treated with at least 1 dose of the trial regimen (including both trial drug and computerized cognitive training (CCT)).
Plan to share individual participant data: YES
IPD sharing description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.
IPD time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Clinical trial NCT04301310: Study to Evaluate the Effect of Rifampin on the Drug Levels in Blood and Safety of BMS-986235 in Healthy Participants
Official title: A Phase 1, Open-label Study to Evaluate the Effect of Rifampin on the Single Dose Pharmacokinetics, Safety, and Tolerability of BMS-986235 in Healthy Participants
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Business objectives have changed
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-03-09
Primary completion date: 2020-03-16
Completion date: 2020-03-16
Clinical trial NCT04395950: Effects of ACC Inhibitor on Lipid and Lipoprotein Metabolism
Official title: A Phase 1B, Single-Blinded, Linear Two Period, Placebo-controlled Study to Evaluate the Effects of 10 mg/Day of PF-05221304, Liver Targeted Acetyl-CoA Carboxylase Inhibitor (ACCi) on Very Low Density Lipoprotein ApoB100 and TG Secretion
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Poor enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-31
Primary completion date: 2021-08-19
Completion date: 2021-08-19
Plan to share individual participant data: NO
Clinical trial NCT03259308: Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 302)
Acronym: FIGARO UC 302
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.
Enrollment: 279.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-12-05
Primary completion date: 2020-07-15
Completion date: 2020-10-06
Baseline population: Safety set consisted of all participants who had received at least 1 dose of investigational product.
Limitations and caveats: The study was terminated as per the sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.
Clinical trial NCT04987944: Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma
Official title: A Phase 1b, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Safety and Efficacy of Oral Zavegepant in Subjects With Mild Allergic Asthma
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.
Enrollment: 45.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-18
Primary completion date: 2023-03-29
Completion date: 2023-04-04
Baseline population: Safety analysis set included all randomized participants who received at least 1 dose of study therapy.
Plan to share individual participant data: NO
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT05161936: A Study to Evaluate Lumasiran in Adults With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Lumasiran in Patients With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels
Sponsor: Alnylam Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study terminated early due to low enrollment
Enrollment: 2.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-01-27
Primary completion date: 2022-11-01
Completion date: 2022-11-01
Baseline population: No participants were enrolled or treated with Lumasiran Dose 2.
Plan to share individual participant data: NO
Clinical trial NCT04082676: Height Versus Height and Weight Based Spinal Bupivacaine on Maternal Haemodynamics for Elective Cesarean in Short Stature Patients
Official title: Effect of Height Versus Height and Weight Based Intrathecal Bupivacaine Dose on Maternal Haemodynamics for Elective Caesarean Section in Short Stature Patients: A Randomized Trial
Sponsor: B.P. Koirala Institute of Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 112.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-30
Primary completion date: 2021-09-01
Completion date: 2021-09-01
Plan to share individual participant data: YES
IPD sharing description: The final research data will be stored in Mendeley. The final data will be released and shared during the publication process of the manuscript.
IPD time frame: The final research data and study protocol will be shared with the journal accepting the article for publication. It will be available simultaneously after publication of the article.
IPD access criteria: The IPD link will be accessed from the link provided in the published manuscript. The IPD may also be available to other researchers by the investigators upon request.
Clinical trial NCT02974426: To Evaluate the Optimal Timing of Postoperative Radiotherapy in Patients With IIIA(N2) Non-Small Cell Lung Cancer
Official title: Phase III Study to Evaluate the Optimal Timing of Postoperative Radiotherapy for High Risk of Locoregional Recurrence Patients With Completely Resected Stage IIIA(N2) Non-Small Cell Lung Cancer
Sponsor: Shanghai Chest Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Enrollment was delayed and the number of eligible patients significantly declined with the use of neoadjuvant or adjuvant ICIs and TKIs therapies. Thus, this trial was closed due to insufficient accrual.
Enrollment: 132.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-11-30
Primary completion date: 2024-02-29
Completion date: 2024-02-29
Plan to share individual participant data: NO
Clinical trial NCT02923921: Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer
Official title: Randomized Study of AM0010 in Combination With FOLFOX Compared to FOLFOX Alone as Second-line Tx in Pts With Metastatic Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen
Acronym: Sequoia
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 567.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-03-01
Primary completion date: 2019-09-09
Completion date: 2020-03-05
Baseline population: All randomized participants.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT03342859: Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned
Official title: An Open-label, Parallel Group, Multi-center Study to Investigate Pharmacodynamic Effects After Daily Administration of Vilaprisan or Ulipristal Acetate for 8-12 Weeks in Patients With Uterine Fibroids for Whom Surgery (Hysterectomy or Myomectomy) is Planned
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to findings in the preclinical carcinogenicity studies for vilaprisan (BAY1002670)
Enrollment: 10.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-11-16
Primary completion date: 2018-12-17
Completion date: 2020-01-13