Completed PHASE1 INTERVENTIONAL 3-arm 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

Sponsor: Merckle GmbH

Conditions Bioequivalence

Interventions Gonal-f® XM17 Zoladex®

Updated 7 times since 2017 Last updated: Nov 5, 2021 Started: Feb 28, 2009 Primary completion: May 31, 2009 Completion: Dec 31, 2009

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Bioequivalence, this trial is completed. The trial is conducted by Merckle GmbH and has accumulated 7 data snapshots since 2009. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

7 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Dec 2021 — Jul 2024 [monthly]

Completed PHASE1
Jan 2021 — Dec 2021 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE1
Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

Feb 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Merckle GmbH

Data source: Teva Branded Pharmaceutical Products R&D, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.