Study to Evaluate LevoCept, a Long-Acting Reversible Intrauterine System, for Contraceptive Efficacy Safety and Tolerability.
Not Recruiting
99 years and younger
All
Phase
3
1525 participants needed
1 Location
Brief description of study
The primary objective of the study is to assess the contraceptive efficacy (prevention of pregnancy) of LevoCept. The secondary objectives of the study are to assess the following for LevoCept: Safety and tolerability; Return to fertility after LevoCept removal, only for subjects requesting LevoCept removal to become pregnant; Release rate of LNG from the intrauterine system (IUS) and resulting pharmacokinetics of LNG (PK substudy only).
Detailed description of study
The primary objective of the study is to assess the contraceptive efficacy (prevention of pregnancy) of LevoCept. The secondary objectives of the study are to assess the following for LevoCept: Safety and tolerability; Return to fertility after LevoCept removal, only for subjects requesting LevoCept removal to become pregnant; Release rate of LNG from the intrauterine system (IUS) and resulting pharmacokinetics of LNG (PK substudy only).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
Contraceptive, intrauterine device (IUD), birth control
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Age: - 99 Years
-
Gender: All
Woman Age 18+ of child bearing age and interested in using an intrauterine device (IUD) for birth control for up to 5 years.
Updated on
08 May 2024.
Study ID: 844951
