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Study of the Safety and Efficacy of Ulipristal Acetate (UPA) Used Daily as a Contraceptive — CCN013B  

Contraception Clinical Trial

Official title:
A Multi-center, Open-label, Non-comparative Study of the Safety and Contraceptive Efficacy of Continuous Daily Oral 10 mg of Ulipristal Acetate (UPA)

Clinical Trial Summary

This is a Phase IIb multicenter, open-label, non-comparative trial of continuous daily oral 10 mg of ulipristal acetate (UPA) to evaluate its contraceptive efficacy as the primary method of contraception.

Clinical Trial Description

This is an open-label study being conducted at 18 centers. The dose of 10 mg was chosen for daily continuous use of ulipristal acetate (UPA). The study will enroll approximately 300 subjects to use the UPA for 6 months (182 days). In addition to contraceptive efficacy, safety, overall acceptability of the product, and the number of bleeding/spotting days will be assessed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03296098
Study type Interventional
Source Health Decisions
Contact
Status Suspended
Phase Phase 2
Start date December 2020
Completion date December 2022
View Details
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