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

Outcome

Met primary endpoint

paper PK bioequivalence of single 300-IU sc doses of XM17 to the reference product Gonal-f® was statistically demonstrated. PMID 26621118 ↗

paper with the CIs contained within the predefined interval (0.8, 1.25). PMID 26621118 ↗

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

Evaluation	Drug	Modality	Dose	Route
Subject	Gonal-f	Protein / enzyme biologic	300 iu	Subcutaneous
Subject	XM17	Protein / enzyme biologic	300 iu	Subcutaneous
Comparator	Goserelin	Other / unclassified	3.6 mg	Subcutaneous

Indications

No indication recorded.