A Phase III Study of FE 999913 in Japanese Female Patients Undergoing Fertility Treatment

Phase 3 Completed 108 enrolled Ferring Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

The purposes of the study are to verify sufficient supplementation of luteal hormone after administrating FE999913 Vaginal Tablet twice a day (BID) or three times a day (TID) and to determine the efficacy and safety of FE999913 Vaginal Tablet in Japanese women undergoing fertility treatment with IVF-ET (a fresh embryo transfer).

Timeline

Start: 2012-10
Primary completion: 2013-08
Completion: 2013-08

Publications

Fujiwara T. A multi-center, randomized, open-label, parallel group study of a natural micronized progesterone vaginal tablet as a luteal support agent in Japanese women undergoing assisted reproductive technology. Reprod Med Biol. 2015;14(4):185-193. doi: 10.1007/s12522-015-0211-y. Epub 2015 Jun 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Progesterone	Other / unclassified	100 mg	Other

Indications

No indication recorded.