Phase 4 N=64 Randomized Treatment

Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA

Obesity · Contraception

Bottom Line

View on ClinicalTrials.gov: NCT02859337 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2024

Primary outcome: Primary: Number of Participants With Delay in Follicular Rupture Beyond 5 Days — 46; 43; 12 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: UPA-ECx1 (Drug); UPA-ECx2 (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Oregon Health and Science University
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Delay in Follicular Rupture Beyond 5 Days	46; 43; 12	—
SECONDARY Maximum Serum Concentration of Ulipristal Acetate	197.1; 312.4; 98.4	—

Summary

Obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed emergency contraceptives. Our preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed emergency contraceptives in obese women. More data is needed regarding emergency contraception containing ulipristal acetate. The overall project will be focused on both levonorgestrel (LNG) - and ulipristal acetate (UPA)-containing emergency contraception but this protocol registration is for the UPA aspect of the study procedures.

Eligibility Criteria

Inclusion Criteria

Generally healthy women
Aged 18-35 years old
Regular menses (every 21-35 days) experiencing an ovulatory screening cycle with a progesterone level of 3 ng/mL or greater
Subjects must have a BMI of >30kg/m2 and weight at least 80kg or more OR a BMI <25kg/m2 and a weight of less than 80kg.

Exclusion Criteria

Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian Syndrome
Impaired liver or renal function
Actively seeking or involved in a weight loss program (must be weight stable) pregnancy, breastfeeding, or seeking pregnancy
Recent (within last 8 weeks) use of hormonal contraception
Current use of drugs that interfere with metabolism of sex steroids
Smokers.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02859337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.