Trials / Completed
CompletedNCT01416987
A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 600 (actual)
- Sponsor
- Merck KGaA, Darmstadt, Germany · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This prospective study collected safety information from more than 600 participants treated with Pergoveris®. During the Post-Marketing Surveillance (PMS) period, data about the participant's background, participant's medical history, Pergoveris® indication, prior infertility medication, Pergoveris® treatment status, concomitant drugs, all adverse events (regardless of the causal relationship to Pergoveris®) and efficacy (follicular growth and clinical pregnancy) were collected for study purposes.The post marketing surveillance was based on all cases treated with Pergoveris®.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pergoveris® | Participants received once daily injection of a single vial of Pergoveris® which contained 150 International Units (IU) of follitropin alfa (r-hFSH) and 75 IU of lutropin alfa (r-hLH), for approximately 8 days. |
Timeline
- Start date
- 2011-08-14
- Primary completion
- 2018-05-10
- Completion
- 2018-05-10
- First posted
- 2011-08-15
- Last updated
- 2019-07-19
- Results posted
- 2019-07-19
Locations
2 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01416987. Inclusion in this directory is not an endorsement.