Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-30 @ 3:30 AM
Study NCT ID:
NCT03537768
Status:
TERMINATED
Last Update Posted:
2025-11-20
First Post:
2018-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg
Sponsor:
Kimberly Myer
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We weren't seeing as many pregnancies we initially thought.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: