Alison B Edelman1, Ganesh Cherala2, Hong Li3, Francis Pau4, Diana L Blithe5, Jeffrey T Jensen6. 1. Department of Obstetrics & Gynecology, Oregon Health & Science University, Portland, OR; Oregon National Primate Research Center, Beaverton, OR. Electronic address: edelmana@ohsu.edu. 2. Department of Obstetrics & Gynecology, Oregon Health & Science University, Portland, OR; CONRAD, Arlington, VA. 3. Department of Obstetrics & Gynecology, Oregon Health & Science University, Portland, OR. 4. Oregon National Primate Research Center, Beaverton, OR. 5. Eunice Kennedy Shriver National Institute of Child Health and Human Development. 6. Department of Obstetrics & Gynecology, Oregon Health & Science University, Portland, OR; Oregon National Primate Research Center, Beaverton, OR.
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. Copyright Â
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 obesewomen. 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. Copyright Â
Authors: T R Dunson; P D Blumenthal; F Alvarez; V Brache; L Cochon; B Dalberth; L Glover; R Remsburg; K Vu; D Katz Journal: Fertil Steril Date: 1998-02 Impact factor: 7.329
Authors: Alison B Edelman; Nichole E Carlson; Ganesh Cherala; Myrna Y Munar; Richard L Stouffer; Judy L Cameron; Frank Z Stanczyk; Jeffrey T Jensen Journal: Contraception Date: 2009-06-04 Impact factor: 3.375