NCT03296098

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Premier Research · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Contraception
• Healthy Female

Interventions

Type	Name	Description
DRUG	Ulipristal acetate	Ulipristal aceteate 5 mg oral tablets to take two tablets daily.

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-01-01
• Completion: 2022-12-01
• First posted: 2017-09-28
• Last updated: 2025-11-20

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study