Trials / Completed
CompletedNCT04654039
Post-Marketing Surveillance (PMS) Protocol of REKOVELLE Pre-Filled Pen (Follitropin Delta)
Post-Marketing Surveillance (PMS) Protocol of REKOVELLE Pre-Filled Pen(Follitropin Delta)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 728 (actual)
- Sponsor
- Ferring Pharmaceuticals · Industry
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This post-marketing surveillance study was conducted in accordance with the regulations for re-examination of domestic new drugs (Standard for Re-Examination of New Drugs: Ministry of Food and Drug Safety \[MFDS\]: Notification No. 2017-95, 21 Nov, 2017). It was important to monitor the pattern of drug use in general practice for a long term after marketing authorization, and to investigate and identify potential new adverse events (AEs) and their onset status that were not observed during the drug development phases and any potential factors that affect safety and effectiveness of the new drug.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Other: Non intervention | Non intervention |
Timeline
- Start date
- 2020-10-26
- Primary completion
- 2023-10-28
- Completion
- 2023-10-28
- First posted
- 2020-12-04
- Last updated
- 2025-04-01
Locations
15 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04654039. Inclusion in this directory is not an endorsement.