Phase 4
Completed N=64
Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA
Source: ClinicalTrials.gov NCT02859337 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Number of Participants With Delay in Follicular Rupture Beyond 5 Days — 46; 43; 12 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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.
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. Informational only — not medical advice.