Trial Outcomes & Findings for A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa) (NCT NCT01416987)

Results Overview

Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse events included both Serious AEs and non-serious AEs. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse Drug Reactions (ADR) was defined as an adverse event for which a causal relationship between the product and the occurrence was suspected, that was judged possible or probable by the reporting physician.

Recruitment status

COMPLETED

Target enrollment

600 participants

Primary outcome timeframe

2463 days

Results posted on

2019-07-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	600
Overall Study COMPLETED	600
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pergoveris® n=600 Participants 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.
Age, Continuous	34.58 Years STANDARD_DEVIATION 3.83 • n=600 Participants
Sex: Female, Male Female	600 Participants n=600 Participants
Sex: Female, Male Male	0 Participants n=600 Participants

PRIMARY outcome

Timeframe: 2463 days

Population: Safety analysis set included all participants who received at least one dose of Pergoveris®.

Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse events included both Serious AEs and non-serious AEs. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse Drug Reactions (ADR) was defined as an adverse event for which a causal relationship between the product and the occurrence was suspected, that was judged possible or probable by the reporting physician.

Outcome measures

Outcome measures
Measure	Pergoveris® n=600 Participants 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.
Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR) Adverse event (AE)	16 Participants
Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR) Adverse drug reaction (ADR)	13 Participants

SECONDARY outcome

Timeframe: 2463 days

Population: Effectiveness analysis set included participants who were evaluated for follicular growth (FG) after treatment with Pergoveris®, except those; who were not assessed for FG; whose assessments of FG were considered 'undecidable' based on Human Chorionic Gonadotropin (HCG) not administered, ultrasonography not done on the day of HCG administration.

Number of participants with one follicle of more than 17mm of mean diameter on ultrasonography were reported.

Outcome measures

Outcome measures
Measure	Pergoveris® n=532 Participants 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.
Number of Participants With at Least One Follicle of More Than 17 Millimeter (mm) of Mean Diameter on Ultrasonography	528 Participants

SECONDARY outcome

Timeframe: 2463 days

Population: Safety analysis set included all participants who received at least one dose of Pergoveris®.

The clinical pregnancy was defined as a positive serum in urine HCG test or as the presence of gestational sac or yolk sac by an ultrasonography confirmation.

Outcome measures

Outcome measures
Measure	Pergoveris® n=600 Participants 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.
Number of Participants With Clinical Pregnancy as Per Safety Analysis Set	246 Participants

SECONDARY outcome

Timeframe: 2463 days

Population: Effectiveness analysis set included participants who were evaluated for follicular growth (FG) after treatment with Pergoveris ®, except those; who were not assessed for FG; whose assessments of FG were considered 'undecidable' based on Human Chorionic Gonadotropin (HCG) not administered, ultrasonography not done on the day of HCG administration.

The clinical pregnancy was defined as a positive serum in urine HCG test or as the presence of gestational sac or yolk sac by an ultrasonography confirmation.

Outcome measures

Outcome measures
Measure	Pergoveris® n=532 Participants 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.
Number of Participants With Clinical Pregnancy as Per Effectiveness Analysis Set	227 Participants

Adverse Events

Pergoveris®

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pergoveris® n=600 participants at risk 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.
Reproductive system and breast disorders Ovarian hyperstimulation syndrome	0.17% 1/600 • 2463 days
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.17% 1/600 • 2463 days

Other adverse events

Other adverse events
Measure	Pergoveris® n=600 participants at risk 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.
Reproductive system and breast disorders Ovarian hyperstimulation syndrome	1.2% 7/600 • 2463 days
Gastrointestinal disorders Abdominal distension	0.17% 1/600 • 2463 days
Gastrointestinal disorders Abdominal pain lower	0.17% 1/600 • 2463 days
Gastrointestinal disorders Nausea	0.17% 1/600 • 2463 days
General disorders Injection site erythema	0.17% 1/600 • 2463 days
General disorders Injection site pain	0.17% 1/600 • 2463 days
General disorders Injection site pruritus	0.17% 1/600 • 2463 days
Infections and infestations Nasopharyngitis	0.17% 1/600 • 2463 days
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.17% 1/600 • 2463 days

Additional Information

Communication Center

Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place