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:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
NCT ID:
NCT02652650
Brief Summary:
The purpose of this study is to evaluate the effect of steady-state concentrations of JNJ-63623872 on the steady-state pharmacokinetics of ethinylestradiol and norethindrone in healthy female participants.
Detailed Description:
This is a Phase 1 and open-label study. The study consists of Screening Phase (less than or equal to (\<=) 28 days before Day 1), Treatment Phase (Day 1 up to Day 78) and Follow up Phase (10 to 14 days after last study drug intake or, if an adverse event occurs, 30 to 35 days after last study drug intake). Treatment phase will consist of three Oral Contraceptive (OC) cycles (each cycle consists of 21 days of ethinylestradiol/norethindrone followed by 7 pill-free days). The duration of the treatment phase, including the OC-free period of Cycles I and II, will be 78 days. Blood samples will be collected for measurement of pharmacokinetic (Pk) parameters. Participants' safety will be monitored throughout the study.
Study:
NCT02652650
Study Brief:
Protocol Section:
NCT02652650