Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT06657105
Brief Summary:
The main purpose of the study is to assess the effect of multiple doses of baxdrostat on the pharmacokinetics (PK) of a single dose of combined oral ethinyl estradiol (EE) and levonorgestrel (LNG). Safety and tolerability of baxdrostat will be assessed during the study.
Detailed Description:
This is an open-label, 3-period fixed sequence study conducted at a single Clinical Unit.
The study will comprise of:
* A Screening period of maximum 28 days.
* Period 1: - From Day -1 to Day 5.
* Period 2: -From Day 6 to Day 16
* Period 3: - From Day 17 to Day 23.
* A Final Follow-up Visit, 7 (± 2) days after the last PK sample in Period 3.
Study:
NCT06657105
Study Brief:
Protocol Section:
NCT06657105