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. 2017 Jan;95(1):55-58.
doi: 10.1016/j.contraception.2016.07.018. Epub 2016 Jul 27.

Levonorgestrel butanoate intramuscular injection does not reliably suppress ovulation for 90 days in obese and normal-BMI women: a pilot study

Alison B Edelman  1 , Ganesh Cherala  2 , Hong Li  3 , Francis Pau  4 , Diana L Blithe  5 , Jeffrey T Jensen  6
Affiliations

Levonorgestrel butanoate intramuscular injection does not reliably suppress ovulation for 90 days in obese and normal-BMI women: a pilot study

Alison B Edelman et al. Contraception. 2017 Jan.

Abstract

Background: We performed a pilot evaluation of a new formulation of levonorgestrel butanoate (LB) designed to be a long-acting injectable (6 months) contraceptive to determine pharmacodynamic end points in normal-body mass index (BMI) and obese women.

Study design: Obese (BMI ≥30 kg/m2) and normal-BMI, otherwise healthy, women received a single intramuscular injection of LB after ovulation was confirmed in a baseline cycle. The primary outcome was return of ovulation in days.

Results: A total of 14 women enrolled and completed the study [normal BMI n=9, median BMI 22.7kg/m2 (range 19.4-25.8); obese n=5, median BMI 35.7kg/m2 (30.1-39.2)]. The first 6 subjects (normal BMI=4/9, obese BMI=2/5) received 40 mg of LB, and the remaining 8 received 20 mg. All women except one returned to ovulation prior to 6 months. Return to ovulation occurred earlier in the obese group; 3/5 obese and 0/9 normal BMI subjects returned to ovulation within 90 days (p=.03). No serious adverse events were reported during the study.

Conclusion: Return to ovulation was earlier than 6 months in both BMI groups but more so in the obese BMI group.

Implications: Since return of ovulation was earlier than expected for this LB injectable formulation, additional steps are needed to develop a preparation suitable as a longer-lasting product.

Keywords: Body weight; Contraception; Contraceptive injection; Levonorgestrel butanoate; Obesity; Pharmacokinetics.

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Figures

Figure 1
Figure 1
Kaplan-meier estimated ovulation-free survival curve (time to first ovulation following treatment; top graph 20mg vs. 40 mg LB doses, bottom graph BMI<30kg/m2 vs. BMI≥30kg/m2.
Figure 2
Figure 2
Days to ovulation for each participant according to BMI and LB dose [text box includes median (range) of days to ovulation for each BMI group].
See this image and copyright information in PMC

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