chufangao/CTO huggingface dataset:
Clinical trial NCT01886794: Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse
Official title: Role of Hormonal Status on Vascularization and Vaginal Tissue in Women With Pelvic Organ Prolapse
Sponsor: The University of Texas Medical Branch, Galveston (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Collaborator moved and not able to recreate full study team
Enrollment: 10.0 (ACTUAL)
Number of arms: 3.0
Start date: 2013-06-06
Primary completion date: 2023-12-11
Completion date: 2023-12-11
Clinical trial NCT03391882: A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes)
Official title: An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations
Sponsor: Sumitomo Pharma America, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 113.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-19
Primary completion date: 2021-08-11
Completion date: 2021-08-11
Plan to share individual participant data: YES
IPD sharing description: Individual Patient Data (IPD) for this study may be made available upon request via the Clinical Study Data Request site.
IPD time frame: IPD will be made available upon request within 12 months of posting the study results on ct.gov.
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Clinical trial NCT02023905: Everolimus With and Without Temozolomide in Adult Low Grade Glioma
Official title: PI3K/mTOR Pathway Activation Selected Phase II Study of Everolimus (RAD001) With and Without Temozolomide in the Treatment of Adult Patients With Supratentorial Low-Grade Glioma
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 27.0 (ACTUAL)
Number of arms: 3.0
Start date: 2014-03-19
Primary completion date: 2021-09-30
Completion date: 2021-09-30
Limitations and caveats: Study was closed prematurely due to slow accrual and loss of drug support.
Plan to share individual participant data: NO
Clinical trial NCT03279952: Neurophysiological Markers of Pediatric Irritability and Its Response to Intervention
Official title: Neurophysiological Markers of Pediatric Irritability and Its Response to Intervention
Sponsor: Milton S. Hershey Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: challenge in recruitment\]
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-06-01
Primary completion date: 2024-06-30
Completion date: 2024-06-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04614766: A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors
Official title: A Phase 1/2 Trial Using AZEDRA and LUTATHERA in a Dosimetrically-determined Optimal Combination for Therapy of Selected Patients With Midgut Neuroendocrine Tumors
Acronym: SPORE-3
Sponsor: University of Iowa (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Azedra withdrawn from US market
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-09-30
Primary completion date: 2024-04-23
Completion date: 2024-04-23
Plan to share individual participant data: YES
IPD sharing description: Participants must opt in to data sharing. For those that do, imaging, adverse event, and treatment data will be provided.
IPD time frame: phase 1 data: 12 months after identifying the maximum dose phase 2 data: 12 months after last participant last visit
IPD access criteria: A data usage agreement and privacy contract will need to be completed between investigators and their institutions. Data are to be destroyed after completion / use.
Clinical trial NCT04945824: A Human Factors Study to Evaluate a Novel Intracanalicular Insertion Device in Healthy Subjects
Official title: An Open-label, Multi-center, Bilateral, Human Factors Study to Evaluate the Utilization and Safety of a Novel Intracanalicular Insertion Device in Healthy Subjects
Sponsor: Ocular Therapeutix, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: inserter device did not perform as expected
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-06-01
Primary completion date: 2022-11-01
Completion date: 2022-11-01
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05156229: A Phase 1/2a Study of CDK-003 in Patients With Cutaneous T-Cell Lymphoma (CTCL).
Official title: A Phase 1/2a Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CDK-003 in Healthy Adult Participants and Intralesionally Administered CDK-003 in Patients With Cutaneous T-cell Lymphoma (CTCL)
Acronym: Part B
Sponsor: Codiak BioSciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: PK/PD from two patients plus the healthy volunteer data confirmed the RP2D and manageable safety profile. Proceeding to Phase II did not require additional data from this Phase I Dose-Finding study.
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-06
Primary completion date: 2022-08-24
Completion date: 2022-08-24
Plan to share individual participant data: NO
Clinical trial NCT02575339: MLN0128 Compared to Sorafenib in Advanced or Metastatic Hepatocellular Carcinoma
Official title: An Open Label Randomized Phase I/II Trial of MLN0128 Compared to Sorafenib in Patients With Advanced or Metastatic Hepatocellular Carcinoma: Big Ten Cancer Research Consortium BTCRC-GI13-002
Sponsor: Big Ten Cancer Research Consortium (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Funder Decision
Enrollment: 11.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-07-18
Primary completion date: 2018-06-26
Completion date: 2020-11-24
Baseline population: This study was terminated at Phase I.The official reason for study termination was Funder Decision due to lack of accrual. Dose level 1 has 7 subjects since one of the subjects (subject #6) had to come off treatment early but did not have a DLT and so the subject was replaced to have the appropriate number of subjects for the dose decision.
Clinical trial NCT04374279: Trial to Promote Recovery From COVID-19 With Endocrine Therapy
Official title: A Phase II Trial to Promote Recovery From COVID-19 With Endocrine Therapy
Acronym: RECOVER
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Limited resources.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-30
Primary completion date: 2022-01-31
Completion date: 2022-01-31
Plan to share individual participant data: NO
Clinical trial NCT04403763: Phase 1/2 Study of AGN-241622 in Healthy Participants and Participants With Presbyopia
Official title: A First-in-Human, Phase 1/2, Dose-ascending, Multicenter, Masked, Randomized, Vehicle-controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AGN-241622 in Healthy Participants and Participants With Presbyopia (Stage 1 and Stage 2) and Efficacy in Participants With Presbyopia (Stage 2)
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Strategic considerations
Enrollment: 80.0 (ACTUAL)
Number of arms: 7.0
Start date: 2020-07-27
Primary completion date: 2022-12-05
Completion date: 2022-12-05
Baseline population: The intent-to-treat (ITT) population consists of all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Clinical trial NCT03287245: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Idasanutlin Monotherapy in Participants With Hydroxyurea-Resistant/Intolerant Polycythemia Vera
Official title: A Phase II, Single-Arm, Open-Label Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Idasanutlin Monotherapy in Patients With Hydroxyurea-Resistant/Intolerant Polycythemia Vera
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The Sponsor decided to discontinue the development of idasanutlin in the polycythemia vera indication.
Enrollment: 27.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-02-21
Primary completion date: 2020-03-03
Completion date: 2020-03-03
Clinical trial NCT03176693: Preoperative Alpha Blockade for Pheochromocytoma
Official title: Randomized Controlled Trial of Preoperative Alpha Blockade for Pheochromocytoma
Sponsor: University of California, Los Angeles (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 39.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-05-05
Primary completion date: 2020-01-31
Completion date: 2021-10-10
Plan to share individual participant data: NO
Clinical trial NCT02886962: Oral Anticoagulation in Haemodialysis Patients
Official title: Study of the Benefit / Risk Ratio of Oral Anticoagulation in Hemodialysis Patients With Atrial Fibrillation
Acronym: AVKDIAL
Sponsor: University Hospital, Strasbourg, France (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: not enough patients
Enrollment: 50.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-12
Primary completion date: 2023-12-01
Completion date: 2023-12-01
Plan to share individual participant data: NO
Clinical trial NCT05946551: Treatment of Long CoronaVirus Disease (COVID) (TLC) Feasibility Trial
Official title: Feasibility Assessment of a Decentralized Platform Adaptive Double-Blind, Randomized Controlled Trial Investigating Repurposed Drugs in the Treatment of Post-Acute Sequelae of Coronavirus-19 (PASC)
Sponsor: Emory University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study was terminated due to lack of funding.
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2024-03-08
Primary completion date: 2024-06-24
Completion date: 2024-06-24
Plan to share individual participant data: YES
IPD sharing description: De-identified datasets may be available to external researchers following final analyses. Requests will be evaluated on a case-by-case basis by PI. No data will be released without proof of Institutional Review Board (IRB) approval or determination. Agreements as required by local policies will be completed when necessary.
IPD time frame: Datasets may be available following final analyses and publication.
IPD access criteria: Proposals should be directed to tiffany.austin.walker@emory.edu.
Clinical trial NCT03218722: Early Administration of Prothrombin Concentrate Complex in Patients With Acute Hemorrhage Following Severe Trauma
Official title: Impact of Early Administration of Prothrombin Concentrate Complex in Patients With Acute Hemorrhage Following Severe Trauma
Acronym: PROCOAG
Sponsor: University Hospital, Grenoble (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 350.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-12-29
Primary completion date: 2021-08-31
Completion date: 2022-06-15
Plan to share individual participant data: NO
Clinical trial NCT04223778: Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)
Official title: A Phase 3 Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Antiretroviral Therapy
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 672.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-18
Primary completion date: 2021-09-08
Completion date: 2024-08-26
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT02098161: LCL161 in Treating Patients With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocytosis Myelofibrosis
Official title: Open Label Phase 2 Single Agent Study of LCL-161 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF)
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 50.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-12-18
Primary completion date: 2022-05-19
Completion date: 2022-05-19
Clinical trial NCT03889379: Albuterol and Immune Cell Composition
Official title: Albuterol and Immune Cell Composition
Sponsor: University of Arizona (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Team decided not to initiate study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-20
Primary completion date: 2021-06-20
Completion date: 2021-06-20
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03895502: Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients With Cancer Study
Official title: Optimal Duration of Anticoagulation Therapy for Isolated Distal Deep Vein Thrombosis in Patients With Cancer Study
Acronym: ONCO DVT
Sponsor: Kyoto University, Graduate School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 605.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-27
Primary completion date: 2023-06-30
Completion date: 2023-08-31
Clinical trial NCT03756922: A DDI Study of FDL169 and FDL176 in Healthy Subjects
Official title: A Phase 1/2, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects and in Cystic Fibrosis Subjects Homozygous for the F508del-CFTR Mutation
Sponsor: Flatley Discovery Lab LLC (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: SUSPENDED 
Why stopped: Business reasons
Enrollment: 78.0 (ESTIMATED)
Number of arms: 4.0
Start date: 2018-11-27
Primary completion date: 2020-02-29
Completion date: 2020-02-29
Clinical trial NCT03022578: Laser Interstitial Thermal Therapy and Lomustine in Treating Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma
Official title: Phase II Study of Laser Interstitial Thermal Therapy (LITT) in Recurrent Glioblastoma
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow accrual
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-11-07
Primary completion date: 2021-02-16
Completion date: 2021-02-16
Clinical trial NCT03956589: Functional Respiratory Imaging and Orkambi in CF
Official title: Functional Respiratory Imaging (FRI) to Assess the Short-term Effect of the Product ORKAMBI (Lumacaftor/ Ivacaftor) on Lung Function in ORKAMBInaive Patients With Cystic Fibrosis Homozygous for Phe508del
Sponsor: University Hospital, Antwerp (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Patient inclusion has stopped after interim analysis.
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-10-01
Primary completion date: 2020-04-01
Completion date: 2020-04-01
Plan to share individual participant data: NO
Clinical trial NCT04233502: Efficacy and Safety of Slenyto for Insomnia in Children With ASD
Official title: A Randomized, Placebo Controlled Study to Investigate the Efficacy and Safety of Slenyto® to Alleviate Sleep Disturbances in Children With Autism Spectrum Disorder
Acronym: ASD
Sponsor: Neurim Pharmaceuticals Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Study was not initiated it was decided to cancel this study
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-30
Primary completion date: 2022-09-30
Completion date: 2022-12-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02702518: rhDNase Eye Drops in Patients With Ocular Graft-Vs.-Host Disease
Official title: A Phase I/II Randomized Placebo-Controlled, Double-Blind, Single-Center, Tolerability and Preliminary Efficacy Clinical Trial of Recombinant Human Deoxyribonuclease (rhDNase) Eye Drops in Patients With Ocular Graft-Vs.-Host Disease
Sponsor: University of Illinois at Chicago (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The DSMB committee recommended closing the trial because of the COVID-19 risk in this at-risk oGVHD population if they came for study visits.
Enrollment: 58.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-04-30
Primary completion date: 2020-04-08
Completion date: 2020-04-08
Plan to share individual participant data: NO
Clinical trial NCT05683600: Efficacy and Safety of COVID-19 Vaccine as Booster Vaccination in Adults 18 Years of Age or Older
Official title: A Multicentre, Randomized, Double-blinded, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 as Booster Vaccination in Adults 18 Years of Age or Older
Sponsor: Guangzhou Patronus Biotech Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: According to the development of the novel coronavirus epidemic situation and the company's R\&D decision
Enrollment: 3000.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-12-29
Primary completion date: 2023-07-12
Completion date: 2023-07-12
Clinical trial NCT03433755: Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed Dyslipidemia
Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety and Efficacy of Evolocumab (AMG 145) in Addition to Optimal Stable Background Statin Therapy in Chinese Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Prematurely Discontinued Amgen decision
Enrollment: 259.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-05-09
Primary completion date: 2020-04-24
Completion date: 2020-05-09
Baseline population: Full Analysis Set: All participants who were randomized and received at least 1 dose of study drug.
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Clinical trial NCT02463305: Therapeutic Modulation of the Intestinal Creatine Kinase System in Inflammatory Bowel Disease (IBD)
Official title: Therapeutic Modulation of the Intestinal Creatine Kinase System in Inflammatory Bowel Disease (IBD)
Sponsor: University of Colorado, Denver (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: inability to enroll
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-08-31
Primary completion date: 2023-03-01
Completion date: 2023-03-01
Plan to share individual participant data: NO
Clinical trial NCT04469062: A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis
Official title: A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active- Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Acronym: LUCENT-ACT
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: The trial was terminated secondary to a business decision, the original scientific question rendered moot by the external scientific community.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-04-20
Primary completion date: 2024-03-13
Completion date: 2024-06-05
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 NCT03614494: Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception
Official title: Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception: Randomised Controlled Trial
Sponsor: The University of Hong Kong (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 860.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-20
Primary completion date: 2022-10-05
Completion date: 2022-10-05
Plan to share individual participant data: YES
IPD sharing description: To be assessed and endorsed by the investigation team based on the exact study protocol suggested by the other researchers.
IPD time frame: starting 6 months after publication of results
IPD access criteria: To be assessed and endorsed by the investigation team based on the exact study protocol suggested by the other researchers.