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Recently Published Study Demonstrates Pharmacokinetic Advantages of ENDOMETRIN(R) Over Crinone(R) for Progesterone Supplementation
Date:8/31/2009

PARSIPPANY, N.J., Aug. 31 /PRNewswire/ -- Endometrin(R) (progesterone) Vaginal Inserts, 100 mg showed clear advantages over Crinone* (progesterone gel) for progesterone supplementation, according to the results of a new pharmacokinetic (PK) study. Progesterone is necessary to increase endometrial receptivity for implantation of an embryo and to support early pregnancy.

ENDOMETRIN(R) rapidly reached higher progesterone serum concentrations, produced greater systemic exposure (AUC 0-24), achieved steady state more rapidly, and cleared more rapidly after termination of therapy than Crinone. The study results were published online in Fertility & Sterility, July 15, 2009.

"We are extremely pleased to bring the fertility community a progesterone supplement that dissolves, achieves steady state and clears faster than gel while providing convenience and comfort to patients," said Ed Trott, vice president, medical affairs. "The study results support the benefits provided by Endometrin(R)'s unique mechanism of action, or as we like to say, Dissolves. Delivers. Done."

About the Study

The randomized, open-label, parallel design PK study tested three groups of six healthy subjects, randomized to take Endometrin(R) two times a day or three times a day or Crinone 8% gel daily. Testing was done for a single day and for multiple days. On the single day of dosing, mean C(max) was 17.0 ng/mL in the two times a day group, 19.8 ng/mL in the three times a day group, and 6.8 ng/mL in the gel group. The 24-hour systemic exposure AUC (0-24) was 217 ng h/mL in the two times a day insert group, 284 ng h/mL in the three times a day group, and 81ng h/mL in the gel group.

During the multiple days of dosing, ENDOMETRIN(R) treatments reached steady state within the first two days (24-32 hours), much more rapidly than the gel, which had not reached st
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SOURCE Ferring Pharmaceuticals
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