Description Module

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 @ 12:13 AM
Ignite Modification Date: 2025-12-25 @ 12:13 AM
NCT ID: NCT01209858
Brief Summary: The purpose of this study is to investigate the effects of perampanel on the pharmacokinetics (PK) of a single-dose oral contraceptive (OC)containing ethinylestradiol (EE) and levonorgestrel (LN) (Microgynon-30) and to investigate the effects of repeated dosing of OC containing EE and LN (Microgynon-30) on the PK of a single dose of perampanel.
Detailed Description: This will be an open-label, non-randomized, fixed sequence study in healthy female subjects. The study has 2 parts: Part A investigating the effects of steady state perampanel on the pharmacokinetics (PK) of a single-dose oral contraceptive (OC) containing ethinylestradiol (EE) and levonorgestrel (LN) (Microgynon-30) and Part B investigating the effects of repeated dosing of an OC containing EE and LN (Microgynon-30) on the PK of a single dose of perampanel.
Study: NCT01209858
Study Brief:
Protocol Section: NCT01209858