Trials / Completed
CompletedNCT01312766
Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients
Safety and Efficacy Study Comparing a New hMG Formulation (hMG-IBSA) to a Reference Product (Menopur®) in Patients Undergoing Ovarian Stimulation for in Vitro Fertilisation (IVF)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 270 (actual)
- Sponsor
- IBSA Institut Biochimique SA · Industry
- Sex
- Female
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous hMG preparations when administered to patients undergoing controlled ovarian stimulation for IVF.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Menotropins | Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age. |
| DRUG | Menotropins | Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age. |
Timeline
- Start date
- 2011-02-01
- Primary completion
- 2013-04-01
- Completion
- 2013-12-01
- First posted
- 2011-03-11
- Last updated
- 2016-07-22
- Results posted
- 2014-08-15
Locations
6 sites across 5 countries: Denmark, France, Hungary, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01312766. Inclusion in this directory is not an endorsement.