Evaluation of the Efficacy, Safety, and Tolerability of LevoCept
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Contraception
- Women at Risk for Pregnancy
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: LevoCept Intrauterine Device (IUD)Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 45 years
- Gender
- Only males
Description
Study Design: Prospective, multi-center, single-arm, open-label, Phase 3 clinical study to 3 years with extension up to 5 years Number of Subjects: Approximately 1,525 subjects will be enrolled into the study Study Population: Post-menarcheal, pre-menopausal women up to age 45 years, who are at risk...
Study Design: Prospective, multi-center, single-arm, open-label, Phase 3 clinical study to 3 years with extension up to 5 years Number of Subjects: Approximately 1,525 subjects will be enrolled into the study Study Population: Post-menarcheal, pre-menopausal women up to age 45 years, who are at risk for pregnancy and who desire a long-term intrauterine contraceptive for birth control will be eligible for this study.
Tracking Information
- NCT #
- NCT04457076
- Collaborators
- PRA Health Sciences
- Investigators
- Not Provided
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