Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT07042516
Description:
Description:
De-identified individual participant data (IPD) will be made available to qualified researchers upon reasonable request. Access will be granted following approval of a research proposal and execution of a data-sharing agreement. Data will be shared through a secure platform to ensure confidentiality and compliance with applicable regulations. The shared data may include clinical study reports, anonymized participant-level datasets, and relevant supporting documentation.
Time Frame:
Data will be available upon publication of the primary study results and for a period of 5 years thereafter.
Access Criteria:
Researchers must submit a detailed proposal outlining the intended use of the data. Proposals will be reviewed by an independent data-sharing committee. Approved researchers must adhere to ethical and security guidelines, ensuring proper data use in compliance with applicable laws and regulations.
Study:
NCT07042516
Study Brief:
Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).