NCT02592031

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

An Open, Randomized, Two-way Cross-over Phase I Study to Compare the Bioavailability, Safety and Tolerability of Single s.c. Doses of 300 IU XM17 With 300 IU Gonal-f® in 36 Healthy, Down-regulated Young Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Merckle GmbH · Industry
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	XM17	300 IU corresponds to an injection volume of 0.5 mL.
DRUG	Gonal-f®	300 IU corresponds to an injection volume of 0.5 mL.
DRUG	Zoladex®	3.6 mg

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-05-01
• Completion: 2009-12-01
• First posted: 2015-10-30
• Last updated: 2021-11-09