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Phase 4 N=15 Other

Emergency Contraception and Body Weight: Pilot Study

Contraception · Body Weight

Bottom Line

View on ClinicalTrials.gov: NCT02408692 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel — 10.3; 5.57 ng/mL

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
ECx1 (Drug); ECx2 (Drug)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Oregon Health and Science University
Primary completion
Jul 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel		 10.3; 5.57 —
SECONDARY
Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel		 5.57; 10.52 —

Summary

The purpose of this research study is to determine how body weight changes the drug level of an emergency contraceptive pill containing a hormone called levonorgestrel (LNG). This emergency contraceptive is available to women without a prescription, but has recently been found to not work as well to prevent pregnancies in women of higher body weight. The overall goal of this research is to improve the effectiveness of contraception for women, no matter their weight.

Eligibility Criteria

Inclusion Criteria

  • Subjects are between the ages of 18 and 35
  • Subjects are in good general health
  • Subjects have regular menstrual cycles (between 21 and 35 days)
  • Subjects are willing to use condoms (if you are sexually active with a male partner), subjects are willing to not have sex with men during the study, or subjects have had a tubal ligation (or have a partner who has had a vasectomy) or subjects have a copper intrauterine device (IUD).

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 (8 week) 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 (NCT02408692). 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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