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

Alison Edelman, Ganesh Cherala, Hong Li, Francis Pau, Diana L. Blithe, Jeffrey Jensen

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.

Original languageEnglish (US)
JournalContraception
DOIs
StateAccepted/In press - Jun 20 2016

Fingerprint

Intramuscular Injections
Ovulation
Body Mass Index
levonorgestrel butanoate
Injections
Contraceptive Agents

Keywords

  • Body weight
  • Contraception
  • Contraceptive injection
  • Levonorgestrel butanoate
  • Obesity
  • Pharmacokinetics

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

Levonorgestrel butanoate intramuscular injection does not reliably suppress ovulation for 90 days in obese and normal-BMI women : A pilot study. / Edelman, Alison; Cherala, Ganesh; Li, Hong; Pau, Francis; Blithe, Diana L.; Jensen, Jeffrey.

In: Contraception, 20.06.2016.

Research output: Contribution to journalArticle

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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.",
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N2 - 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.

AB - 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.

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