Study to Compare the Bioavailability, Safety and Tolerability of XM17 in Healthy, Down Regulated Young Women

Summary

Aim of this study is to demonstrate the bioequivalence of single subcutaneous doses of XM17 and Gonal-f® in a confirmatory design. Furthermore, safety and tolerability will be assessed in human healthy female subjects. Only female subjects will be included in the study to reach the objectives of the study.

Timeline

Start

2009-02

Primary completion

2009-05

Completion

2009-12

Publications

• Lammerich A, Mueller A, Bias P. Phase I, two-way, crossover study to demonstrate bioequivalence and to compare safety and tolerability of single-dose XM17 vs Gonal-f(R) in healthy women after follicle-stimulating hormone downregulation. Reprod Biol Endocrinol. 2015 Dec 1;13:130. doi: 10.1186/s12958-015-0124-y.

Drugs

Indications

No indication recorded.