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| Name | Class |
|---|---|
| Merck Ltd. | INDUSTRY |
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®.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pergoveris® | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR) | 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. | 2463 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Follicle of More Than 17 Millimeter (mm) of Mean Diameter on Ultrasonography | Number of participants with one follicle of more than 17mm of mean diameter on ultrasonography were reported. | 2463 days |
| Number of Participants With Clinical Pregnancy as Per Safety Analysis Set |
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Inclusion Criteria:
Exclusion Criteria:
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Infertile participants
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Seoul | 04619 | South Korea | |||
| Research site |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety analysis set included all participants who received at least one dose of Pergoveris®.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR) | 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. | Safety analysis set included all participants who received at least one dose of Pergoveris®. | Posted | Count of Participants | Participants | 2463 days |
|
2463 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | MedDRA, Version 21.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | MedDRA, Version 21.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 23, 2015 | May 9, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 15, 2017 | May 9, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C551396 | pergoveris |
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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. |
| 2463 days |
| Number of Participants With Clinical Pregnancy as Per Effectiveness Analysis Set | 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. | 2463 days |
| Seoul |
| 05505 |
| South Korea |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| 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. |
|
|
| Secondary | Number of Participants With at Least One Follicle of More Than 17 Millimeter (mm) of Mean Diameter on Ultrasonography | Number of participants with one follicle of more than 17mm of mean diameter on ultrasonography were reported. | 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. | Posted | Count of Participants | Participants | 2463 days |
|
|
|
| Secondary | Number of Participants With Clinical Pregnancy as Per Safety Analysis Set | 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. | Safety analysis set included all participants who received at least one dose of Pergoveris®. | Posted | Count of Participants | Participants | 2463 days |
|
|
|
| Secondary | Number of Participants With Clinical Pregnancy as Per Effectiveness Analysis Set | 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. | 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. | Posted | Count of Participants | Participants | 2463 days |
|
|
|
| 0 |
| 600 |
| 2 |
| 600 |
| 14 |
| 600 |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA, Version 21.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA, Version 21.0 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA, Version 21.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA, Version 21.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA, Version 21.0 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA, Version 21.0 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA, Version 21.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA, Version 21.0 | Non-systematic Assessment |
|
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 21.0 | Non-systematic Assessment |
|
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