Trials / Completed
CompletedNCT01794208
Efficacy and Safety of FSH-GEX™ in Comparison With 150 IU Gonal-f®
A Phase II, Multicentre, Multinational, Randomised, Assessor-Blind Trial to Investigate the Efficacy and Safety of Various Dosages of FSH-GEX™ in Comparison With 150 IU Gonal-f® in Women Undergoing ICSI Treatment
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 267 (actual)
- Sponsor
- Glycotope GmbH · Industry
- Sex
- Female
- Age
- 18 Years – 37 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the current study was the determination of the recommended standard treatment dose of FSH-GEX(TM) in women undergoing intracytoplasmic sperm injection (ICSI) treatment as assessed by follicle growth.
Detailed description
This was a phase II, randomized, assessor-blind, comparator-controlled, multiple dose study in women undergoing ICSI treatment. The primary objective of the study was the determination of the recommended standard treatment dose of FSH-GEX™ as assessed by follicle growth dynamics in women between 18 and 37 years of age who were undergoing intracytoplasmic sperm injection treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Follitropin Epsilon | |
| DRUG | Follitropin Alfa |
Timeline
- Start date
- 2013-01-08
- Primary completion
- 2013-07-01
- Completion
- 2013-07-30
- First posted
- 2013-02-18
- Last updated
- 2021-05-07
Locations
8 sites across 2 countries: Germany, Hungary
Source: ClinicalTrials.gov record NCT01794208. Inclusion in this directory is not an endorsement.