RCT Results: Would Double Dosing Emergency Oral Contraceptives Improve Outcomes in Those with Obesity?
BACKGROUND AND PURPOSE:
Obesity is a risk factor for emergency contraception failure
Edelman et al. (Obstetrics & Gynecology, 2022) assessed whether doubling the dose of emergency levonorgestrel (LNG)-containing oral contraception improves pharmacodynamic outcomes in individuals with obesity
Randomized controlled trial
18 to 35 years
Regular menstrual cycles (21 to 35 days)
Weight ≥176 lbs
Single dose: 1.5 mg LNG
Double dose: 3 mg LNG
Ovulation was confirmed in all participants (luteal progesterone level >3 ng/mL)
Participants were monitored with transvaginal ultrasonography and blood sampling for progesterone, LH, and estradiol every other day
Intervention provided at the point when a dominant follicle ≥15 mm was identified
Daily monitoring for up to 7 days
80% power to detect a 30% difference in the proportion of cycles with at least a 5 day delay in follicle rupture (50% decrease)
5% significance level
Sample size calculation: 70 participants (taking into account potential drop out)
Difference in the proportion of participants with no follicle rupture 5 days postdosing between groups
70 total participants
Mean age 28 years | Mean BMI 38
No difference seen in the proportion of participants without follicle rupture more than 5 days post–LNG dosing between the groups
LNG 1.5 mg: 51.4%
LNG 3.0 mg: 68.6%
Among participants with follicle rupture before 5 days, the time to rupture did not differ between groups
The day at which there was a 75% probability of no rupture is day 2 for both groups
Doubling the dose of LNG-based emergency oral contraceptive did not improve rate of ovulation inhibition in participants with obesity, suggesting that double dosing would not improve outcomes in this population
Limitations of this study include ovulation inhibition being used as a proxy for ovulation | Actual outcome of interest would be pregnancy rate
The authors state
Our results do not support a recommendation of double dosing of LNG for emergency contraception in individuals with obesity
Clinical studies suggest that emergency contraception with LNG does not work in women who weigh more than 70 kg, but that ulipristal acetate appears effective
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