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• W2011125629 abstract "To the Editor:We disagree with the results of the trial by Blake et al. (1Blake EJ, Norris PM, Dorfman SE, Longstreth J, Yankov VI. Single and multidose pharmacokinetic study of a vaginal micronized progesterone insert (Endometrin) compared with vaginal gel in healthy reproductive-aged female subjects. Fertil Steril. Published online July 14, 2009.Google Scholar) with regard to the pharmacokinetics of Crinone and Endometrin.Patients in their study were healthy, fertile women with normal ovulatory cycles and progesterone levels. Progesterone levels vary considerably in normal menstrual cycles, and dosing occurred on days 5 to 8 (1-day dosing) and 7 days later in the luteal phase (multiday dosing). Therefore, a significant part of the measured progesterone was most likely endogenously produced.Even if we assume that none of the measured progesterone was endogenous, the data suggest that the blood sample collection may not have adequately estimated the peak and total systemic exposure for Crinone. The estimates for Crinone total systemic exposure by Blake et al. (1Blake EJ, Norris PM, Dorfman SE, Longstreth J, Yankov VI. Single and multidose pharmacokinetic study of a vaginal micronized progesterone insert (Endometrin) compared with vaginal gel in healthy reproductive-aged female subjects. Fertil Steril. Published online July 14, 2009.Google Scholar) are substantially lower than previously reported elsewhere (2Levine H. Watson N. Comparison of the pharmacokinetics of Crinone 8% administered vaginally versus prometrium administered orally in postmenopausal women.Fertil Steril. 2000; 73: 516-521Abstract Full Text Full Text PDF PubMed Scopus (74) Google Scholar) (Crinone label). In the study by Blake's group (1Blake EJ, Norris PM, Dorfman SE, Longstreth J, Yankov VI. Single and multidose pharmacokinetic study of a vaginal micronized progesterone insert (Endometrin) compared with vaginal gel in healthy reproductive-aged female subjects. Fertil Steril. Published online July 14, 2009.Google Scholar), the mean area under the curve (AUC0–24) (Table 2) was 81 ng-h/mL and 264 ng-h/mL after single-dose and multidose administration, respectively. The corresponding values reported previously were 133 ng-h/mL2 and 167 ng-h/mL (Crinone label, calculated from Cavg 0–24 data) after single dose and 392 ng-h/mL (Crinone label) after multidose. An explanation for this discrepancy is the lack of a 6-hour blood sample. With Crinone, the Tmax for progesterone in the previous studies approximated 5 to 7 hours (compared with 12 to 13 hours in their study). The shape of the concentration-time curves for Crinone in Figures 1 and 3 of their study supports the conclusion that systemic exposure may not have been adequately estimated.Also, variability of total exposure was not reported. The coefficients of variation for the AUC0–24 values for the single dose are calculated to be 52.1%, 50.4%, and 51.4% for the twice-daily insert, the three-times-a-day insert, and Crinone, respectively, and 38.8%, 24.3%, and 42.7% after multiple doses. Therefore, variances in the pharmacokinetic parameters are similar and substantial for all formulations, resulting in the low power of this study to distinguish between treatments, given the small sample size and noncrossover design.Furthermore, there are few data to support the assertion that a progesterone level of 10 ng/mL is associated with good outcomes in an IVF cycle. On the contrary, the consensus is that blood progesterone levels do not correlate with pregnancy outcome in an IVF cycle (3Chantilis S.J. Zeitoun K.M. Patel S.I. Johns D.A. Madziar V.A. McIntire D.D. Use of Crinone vaginal progesterone gel for luteal support in in vitro fertilization cycles.Fertil Steril. 1999; 72: 823-829Abstract Full Text Full Text PDF PubMed Scopus (60) Google Scholar, 4Williams S.C. Donahue J. Muasher S.J. Vaginal progesterone therapy during programmed cycles for frozen embryo transfer: an analysis of serum progesterone levels and pregnancy rates.Fertil Steril. 2000; 74 ([abstract P-363]): S209Abstract Full Text Full Text PDF Google Scholar).Finally, the large clinical trial (5Doody K.J. Schnell V.L. Foulk R.A. Miller C.E. Kolb B.A. Blake E.J. Yankov V.I. Endometrin for luteal phase support in a randomized, controlled, open-label, prospective IVF clinical trial using a combination of Menopur and Bravelle.Fertil Steril. 2009; 91: 1012-1017Abstract Full Text Full Text PDF PubMed Scopus (46) Google Scholar) referenced by the Blake study found a primary efficacy result for ongoing pregnancy of 42% for Crinone, 42% for Endometrin three times a day, and 39% for Endometrin two times a day, leading us to question the conclusions of their study. To the Editor: We disagree with the results of the trial by Blake et al. (1Blake EJ, Norris PM, Dorfman SE, Longstreth J, Yankov VI. Single and multidose pharmacokinetic study of a vaginal micronized progesterone insert (Endometrin) compared with vaginal gel in healthy reproductive-aged female subjects. Fertil Steril. Published online July 14, 2009.Google Scholar) with regard to the pharmacokinetics of Crinone and Endometrin. Patients in their study were healthy, fertile women with normal ovulatory cycles and progesterone levels. Progesterone levels vary considerably in normal menstrual cycles, and dosing occurred on days 5 to 8 (1-day dosing) and 7 days later in the luteal phase (multiday dosing). Therefore, a significant part of the measured progesterone was most likely endogenously produced. Even if we assume that none of the measured progesterone was endogenous, the data suggest that the blood sample collection may not have adequately estimated the peak and total systemic exposure for Crinone. The estimates for Crinone total systemic exposure by Blake et al. (1Blake EJ, Norris PM, Dorfman SE, Longstreth J, Yankov VI. Single and multidose pharmacokinetic study of a vaginal micronized progesterone insert (Endometrin) compared with vaginal gel in healthy reproductive-aged female subjects. Fertil Steril. Published online July 14, 2009.Google Scholar) are substantially lower than previously reported elsewhere (2Levine H. Watson N. Comparison of the pharmacokinetics of Crinone 8% administered vaginally versus prometrium administered orally in postmenopausal women.Fertil Steril. 2000; 73: 516-521Abstract Full Text Full Text PDF PubMed Scopus (74) Google Scholar) (Crinone label). In the study by Blake's group (1Blake EJ, Norris PM, Dorfman SE, Longstreth J, Yankov VI. Single and multidose pharmacokinetic study of a vaginal micronized progesterone insert (Endometrin) compared with vaginal gel in healthy reproductive-aged female subjects. Fertil Steril. Published online July 14, 2009.Google Scholar), the mean area under the curve (AUC0–24) (Table 2) was 81 ng-h/mL and 264 ng-h/mL after single-dose and multidose administration, respectively. The corresponding values reported previously were 133 ng-h/mL2 and 167 ng-h/mL (Crinone label, calculated from Cavg 0–24 data) after single dose and 392 ng-h/mL (Crinone label) after multidose. An explanation for this discrepancy is the lack of a 6-hour blood sample. With Crinone, the Tmax for progesterone in the previous studies approximated 5 to 7 hours (compared with 12 to 13 hours in their study). The shape of the concentration-time curves for Crinone in Figures 1 and 3 of their study supports the conclusion that systemic exposure may not have been adequately estimated. Also, variability of total exposure was not reported. The coefficients of variation for the AUC0–24 values for the single dose are calculated to be 52.1%, 50.4%, and 51.4% for the twice-daily insert, the three-times-a-day insert, and Crinone, respectively, and 38.8%, 24.3%, and 42.7% after multiple doses. Therefore, variances in the pharmacokinetic parameters are similar and substantial for all formulations, resulting in the low power of this study to distinguish between treatments, given the small sample size and noncrossover design. Furthermore, there are few data to support the assertion that a progesterone level of 10 ng/mL is associated with good outcomes in an IVF cycle. On the contrary, the consensus is that blood progesterone levels do not correlate with pregnancy outcome in an IVF cycle (3Chantilis S.J. Zeitoun K.M. Patel S.I. Johns D.A. Madziar V.A. McIntire D.D. Use of Crinone vaginal progesterone gel for luteal support in in vitro fertilization cycles.Fertil Steril. 1999; 72: 823-829Abstract Full Text Full Text PDF PubMed Scopus (60) Google Scholar, 4Williams S.C. Donahue J. Muasher S.J. Vaginal progesterone therapy during programmed cycles for frozen embryo transfer: an analysis of serum progesterone levels and pregnancy rates.Fertil Steril. 2000; 74 ([abstract P-363]): S209Abstract Full Text Full Text PDF Google Scholar). Finally, the large clinical trial (5Doody K.J. Schnell V.L. Foulk R.A. Miller C.E. Kolb B.A. Blake E.J. Yankov V.I. Endometrin for luteal phase support in a randomized, controlled, open-label, prospective IVF clinical trial using a combination of Menopur and Bravelle.Fertil Steril. 2009; 91: 1012-1017Abstract Full Text Full Text PDF PubMed Scopus (46) Google Scholar) referenced by the Blake study found a primary efficacy result for ongoing pregnancy of 42% for Crinone, 42% for Endometrin three times a day, and 39% for Endometrin two times a day, leading us to question the conclusions of their study. Single and multidose pharmacokinetic study of a vaginal micronized progesterone insert (Endometrin) compared with vaginal gel in healthy reproductive-aged female subjectsFertility and SterilityVol. 94Issue 4PreviewTo determine pharmacokinetic profiles of two times a day and three times a day dosage regimens of Endometrin, a micronized progesterone vaginal insert for luteal support in assisted reproductive technology, compared with a gel. Full-Text PDF Reply of the Authors: Progesterone pharmacokinetic studyFertility and SterilityVol. 93Issue 4PreviewWe wish to correct the misperceptions stated in the letter responding to our pharmacokinetics study of Crinone and Endometrin (1). When compared with Crinone, our results showed that Endometrin rapidly produced higher progesterone serum concentrations, achieved greater systemic exposure, reached steady state more rapidly, and cleared sooner after termination of therapy. Full-Text PDF" @default.
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