Completed PHASE1 INTERVENTIONAL 7-arm NCT01354886

Single Dose FSH-GEX™ in Healthy Volunteers

A Phase I, Monocenter, Randomized, Placebo and Comparator Controlled, Single Blind, Rising Dose, Clinical Study to Determine Single Dose Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Four Doses of FSH-GEX™ According to Adaptive Design (25, 75, 150 and 300 IU) Administered Subcutaneously in Healthy Pituitary-suppressed Female Volunteers

Sponsor: Glycotope Biotechnology GmbH

Conditions Female Infertility

Interventions Bravelle FSH-GEX™ Gonal-f Placebo

Updated 6 times since 2017 Last updated: May 10, 2021 Started: Apr 30, 2011 Primary completion: Oct 31, 2011 Completion: Oct 31, 2011

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

Listed as NCT01354886, this PHASE1 trial focuses on Female Infertility and remains completed. Sponsored by Glycotope Biotechnology GmbH, it has been updated 6 times since 2011, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jun 2021 — Jul 2024 [monthly]

Completed PHASE1
Jan 2021 — Jun 2021 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1

▶ Show 1 earlier version

Jan 2017 — Jun 2018 [monthly]

Completed PHASE1

First recorded

Apr 2011

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Glycotope Biotechnology GmbH
Glycotope GmbH

Data source: Glycotope GmbH

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

Study Locations

• Groningen, Netherlands