NCT03537768

Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg

A Multi-center, Randomized Study of the Efficacy of Ulipristal Acetate (UPA) 30 mg, Levonorgestrel (LNG) 1.5 mg, and LNG 3.0 mg for Emergency Contraception (EC) in Women With Weight ≥ 80 kg

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 532 (actual)
• Sponsor: Kimberly Myer · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The proposed research study is a Phase IIb, multi-center, single-blind, randomized study of UPA 30 mg, LNG 1.5 mg and LNG 3.0 mg to evaluate EC effectiveness in women with weight ≥ 80 kg who present within 72 hours of unprotected intercourse.

Detailed description

Orally-dosed emergency contraception (EC) is highly effective when used properly. EC is up to 90% effective at preventing pregnancy following unprotected intercourse. Both ulipristal acetate (UPA) and levonorgestrel (LNG) delay or inhibit ovulation when used for EC. For individual women, use of EC provides a critical backup to prevent unintended pregnancy. However, obesity may severely impair EC effectiveness. Data from two large randomized control trials to identify risk factors for EC failure. A woman of obese body mass index (BMI) (≥30mg/kg2) using LNG-based EC had more than a 4 times greater risk of pregnancy compared to her normal BMI counterpart and a woman of overweight BMI (25-29.9) was at twice the risk of pregnancy. Failure was also associated with a high body weight. LNG-based EC appears to have a ceiling of efficacy at 70 kg and no efficacy for women 80 kg and above. It is believed that by doubling the dose to LNG 3.0 mg, serum levels of LNG are corrected to a therapeutic range.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	Ulipristal Acetate	UPA Tablet
DRUG	Levonorgestrel	LNG Tablet
DRUG	Levonorgestrel	LNG Tablet (x2)

Timeline

• Start date: 2018-07-12
• Primary completion: 2022-04-20
• Completion: 2022-04-20
• First posted: 2018-05-25
• Last updated: 2025-11-20

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study