N/A
Completed N=600
A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)
Source: ClinicalTrials.gov NCT01416987 ↗Enrolled (actual)
600
Serious AEs
0.3%
Results posted
Jul 2019
Primary outcomePrimary: Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR) — 16; 13 Participants
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®.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR) |
16; 13 | — |
| SECONDARY Number of Participants With at Least One Follicle of More Than 17 Millimeter (mm) of Mean Diameter on Ultrasonography |
528 | — |
| SECONDARY Number of Participants With Clinical Pregnancy as Per Safety Analysis Set |
246 | — |
| SECONDARY Number of Participants With Clinical Pregnancy as Per Effectiveness Analysis Set |
227 | — |
Eligibility Criteria
Inclusion Criteria
- Participants, who were eligible for Pergoveris® treatment according to the indication in the national label of Pergoveris®. The national label approved by Korea Food & Drug Administration is "Pergoveris® in association with a follicle stimulating hormone(FSH) preparation was recommended for the stimulation of follicular development in women with severe Luteinizing Hormone (LH) and FSH deficiency. In clinical trials these participants were defined by an endogenous serum LH level less than (<)1.2 International units per liter IU/L"
Exclusion Criteria
- According to national label
Data sourced from ClinicalTrials.gov (NCT01416987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.