TY - JOUR
T1 - Pharmacokinetics and ovarian suppression during use of a contraceptive vaginal ring in normal-weight and obese women
AU - Westhoff, Carolyn L.
AU - Torgal, Anupama H.
AU - Mayeda, Elizabeth Rose
AU - Petrie, Kelsey
AU - Thomas, Tiffany
AU - Dragoman, Monica
AU - Cremers, Serge
N1 - Funding Information:
Support was provided by NIH grant R01 HD04578 , NIH CTSA grant UL1 RR024156 , an anonymous foundation, and the donation by Merck of Nuvarings and laboratory assays.
PY - 2012/7
Y1 - 2012/7
N2 - OBJECTIVE: Many observational studies indicate higher oral contraceptive failure among obese women, but most clinical trials and physiologic studies do not support these differences. Limited data indicate higher failure rates among obese contraceptive patch users. Data regarding contraceptive vaginal ring performance in obese women are needed. STUDY DESIGN: Twenty normal weight (body mass index [BMI] 19.0-24.9; median, 21.65) and 20 obese (BMI 30.0-39.9; median, 33.7) women enrolled in a prospective study of ethinyl estradiol (EE 2) and etonorgestrel pharmacokinetics and of ovarian follicle development, endometrial thickness, and bleeding patterns, all measured biweekly during the second cycle of contraceptive vaginal ring use. RESULTS: Thirty-seven women completed follow-up. Mean day 0-21 EE2 concentrations were lower among obese vs normal weight women (15.0 vs 22.0 pg/mL, respectively, P = .004), whereas etonorgestrel concentrations were similar (1138 vs 1256 pg/mL, respectively, P = .39). Follicular development was minimal in both groups, with only 5 women achieving a maximum follicle diameter >13 mm at any time during 3 weeks follow-up (3 normal weight and 2 obese women); these women had serum progesterone levels <1.0. Obese women reported more bleeding or spotting than normal weight women (3.6 vs 1.4 days, respectively, P = .01). CONCLUSION: Although obese women had lower EE 2 levels during contraceptive vaginal ring use, they had excellent suppression of ovarian follicle development, similar to normal weight women. This predicts that contraceptive vaginal ring effectiveness will be similar in women with a BMI up to 39.9. The lower serum EE2 levels in the obese women may explain the greater reported bleeding or spotting days.
AB - OBJECTIVE: Many observational studies indicate higher oral contraceptive failure among obese women, but most clinical trials and physiologic studies do not support these differences. Limited data indicate higher failure rates among obese contraceptive patch users. Data regarding contraceptive vaginal ring performance in obese women are needed. STUDY DESIGN: Twenty normal weight (body mass index [BMI] 19.0-24.9; median, 21.65) and 20 obese (BMI 30.0-39.9; median, 33.7) women enrolled in a prospective study of ethinyl estradiol (EE 2) and etonorgestrel pharmacokinetics and of ovarian follicle development, endometrial thickness, and bleeding patterns, all measured biweekly during the second cycle of contraceptive vaginal ring use. RESULTS: Thirty-seven women completed follow-up. Mean day 0-21 EE2 concentrations were lower among obese vs normal weight women (15.0 vs 22.0 pg/mL, respectively, P = .004), whereas etonorgestrel concentrations were similar (1138 vs 1256 pg/mL, respectively, P = .39). Follicular development was minimal in both groups, with only 5 women achieving a maximum follicle diameter >13 mm at any time during 3 weeks follow-up (3 normal weight and 2 obese women); these women had serum progesterone levels <1.0. Obese women reported more bleeding or spotting than normal weight women (3.6 vs 1.4 days, respectively, P = .01). CONCLUSION: Although obese women had lower EE 2 levels during contraceptive vaginal ring use, they had excellent suppression of ovarian follicle development, similar to normal weight women. This predicts that contraceptive vaginal ring effectiveness will be similar in women with a BMI up to 39.9. The lower serum EE2 levels in the obese women may explain the greater reported bleeding or spotting days.
KW - contraceptive vaginal ring
KW - obesity
KW - pharmacodynamics
KW - pharmacokinetics
UR - http://www.scopus.com/inward/record.url?scp=84862654909&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84862654909&partnerID=8YFLogxK
U2 - 10.1016/j.ajog.2012.04.022
DO - 10.1016/j.ajog.2012.04.022
M3 - Article
C2 - 22727346
AN - SCOPUS:84862654909
SN - 0002-9378
VL - 207
SP - 39.e1-39.e6
JO - American Journal of Obstetrics and Gynecology
JF - American Journal of Obstetrics and Gynecology
IS - 1
ER -