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Phase 4 N=70 Randomized Treatment

Effectiveness of Orally Dosed Emergency Contraception in Obese Women - LNG

Obesity

Bottom Line

View on ClinicalTrials.gov: NCT02863445 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: The Number of Participants in Two Treatment Groups (1.5mg Levonorgestrel and 3mg Levonorgestrel) With no Follicle Rupture at 5 Days Within One Menstrual (Treatment) Cycle. — 18; 24 participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Levonorgestrel-based emergency contraception 1.5 mg (Drug); Levonorgestrel-based emergency contraception 3.0mg (Drug)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Oregon Health and Science University
Primary completion
Jan 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
The Number of Participants in Two Treatment Groups (1.5mg Levonorgestrel and 3mg Levonorgestrel) With no Follicle Rupture at 5 Days Within One Menstrual (Treatment) Cycle.		 18; 24 —
SECONDARY
Number of Participants With Follicle Rupture Before 5 Days		 17; 11 —

Summary

Obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed emergency contraceptives. The PI's 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. The overall project will be focused on both levonorgestrel (LNG) - and ulipristal acetate-containing emergency contraception but this protocol registration is for the LNG aspect of the study procedures.

Eligibility Criteria

Inclusion Criteria

  • Generally health women
  • Aged 18-35 years old
  • Regular menses (every 21-35 days) experiencing an ovulatory screening cycle with a progesterone level of 3ng/ml or greater.
  • Subjects must have a BMI of >30 kg/m2 and weigh at least 80 kg or more.

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 (NCT02863445). 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.

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