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The objective of this study was to compare the fertilization rate between the combination of Menopur and Bravelle mixed in the same syringe and Menopur alone, both administered subcutaneously (SC), in subjects undergoing Assisted Reproductive Technology (ART). Additionally the study assessed subjects' ability to mix and store the combination of Menopur and Bravelle and to assess safety of the Menopur and Bravelle combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menopur and Bravelle combination | Experimental | The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20. |
|
| Menopur alone | Active Comparator | The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bravelle | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Fertilization Rate | The fertilization rate was defined for each participant and calculated as the number of 2 pronuclei (fertilized) (2PN) oocytes divided by the total number of oocytes retrieved multiplied by 100. | approximately day 13 (16-20 hours post insemination by in vitro fertilization (IVF) insemination or intracytoplasmic sperm injection (ICSI)) |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of the Subject Comprehension Questionnaire (SCQ) on Day 1 | Subject comprehension questionnaires were completed on Day 1 only by participants assigned to the Menopur and Bravelle treatment arm. On Day 1, the participant read the Mixing Instructions Guide on how to mix and administer the medications at home. The participant was given enough time to read and understand the instructions and ask any questions. The participant then completed the SCQ which consists of 7 questions with YES/NO answers, to self-gauge their understanding of drug administration procedures. Reported data represent the number of participants who answered the question YES. Gonadotropins are referred to as investigational medicinal product (IMP). |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Center for Reproductive Medicine | Lone Tree | Colorado | United States | |||
| Women's Medical Research Group |
A total of 122 subjects (60 Menopur/Bravelle, 62 Menopur) entered pituitary down-regulation and were randomized in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Menopur and Bravelle Combination | The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20. |
| FG001 | Menopur Alone | The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Menopur and Bravelle Combination | The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Fertilization Rate | The fertilization rate was defined for each participant and calculated as the number of 2 pronuclei (fertilized) (2PN) oocytes divided by the total number of oocytes retrieved multiplied by 100. | Intent to treat population | Posted | Mean | Standard Deviation | percentage of oocytes retrieved | approximately day 13 (16-20 hours post insemination by in vitro fertilization (IVF) insemination or intracytoplasmic sperm injection (ICSI)) |
|
Day 1 up to Day 20
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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 | Menopur and Bravelle Combination | The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D050477 | Urofollitropin |
| D008596 | Menotropins |
| ID | Term |
|---|---|
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Menopur | Drug |
|
|
| Day 1 |
| Summary of the Subject Comprehension Questionnaire (SCQ) on Day 6 | Subject comprehension questionnaires were repeated on Day 6 after 5 days of combination therapy by participants assigned to the Menopur and Bravelle treatment arm. The SCQ consists of 7 questions with YES/NO answers to self-gauge participants' understanding of drug administration procedures. Reported data represent the number of participants who answered the question YES. Gonadotropins are referred to as investigational medicinal product (IMP). | Day 6 |
| Summary of Assessor Questionnaire on Day 1 | Participants assigned to the Menopur and Bravelle treatment arm read the Mixing Instructions Guide on how to mix and administer the medications at home. Participants were given enough time to read and understand the instructions and ask any questions. After completing the SCQ, participants prepared and self-administered her assigned first daily dose in the presence of the study coordinator or designee assessor. The assessor then completed a 7 question questionnaire with YES or NO answers to document their assessment of participant understanding of drug administration procedures. Reported data represent the number of participants for whom the assessor answered the question YES. Gonadotropins are referred to as investigational medicinal product (IMP). | Day 1 |
| Summary of Assessor Questionnaire on Day 6 | Participants assigned to the Menopur and Bravelle treatment arm prepared and self-administered her daily dose on Day 6 in the presence of the study coordinator or designee assessor. The assessor then completed a 7 question questionnaire with YES or NO answers to document their assessment of participant understanding of drug administration procedures. Reported data represent the number of participants for whom the assessor answered the question YES. Gonadotropins are referred to as investigational medicinal product (IMP). | Day 6 |
| Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS) | A treatment-emergent AE was any AE occurring after start of investigational medicinal product (IMP) and within the time of residual drug effect, or a pretreatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. The time of residual drug effect was the estimated period of time after the last dose of the IMP, where the effect of the product was still considered to be present based on pharmacokinetic, pharmacodynamic, or other IMP characteristics. | Day 1 up to Day 20 |
| Clearwater |
| Florida |
| United States |
| Reproductive Biology Associates | Atlanta | Georgia | United States |
| Fertility Center of Illinois | Chicago | Illinois | United States |
| The Advanced IVF Institute | Naperville | Illinois | United States |
| Shady Grove Fertility | Rockville | Maryland | United States |
| The Center for Assisted Reproduction | Bedford | Texas | United States |
| Houston Fertility Institute | Houston | Texas | United States |
| Center of Reproductive Medicine | Webster | Texas | United States |
| Seattle Reproductive Medicine | Seattle | Washington | United States |
| No transfer due to risk of OHSS |
|
| No transfer due to elevated progesterone |
|
| BG001 | Menopur Alone | The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Number | participants |
|
| Current Smokers | Number | participants |
|
| Ever Smoked? | Number | participants |
|
| Current Drinkers | Number | participants |
|
| OG001 | Menopur Alone | The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20. |
|
|
|
| Secondary | Summary of the Subject Comprehension Questionnaire (SCQ) on Day 1 | Subject comprehension questionnaires were completed on Day 1 only by participants assigned to the Menopur and Bravelle treatment arm. On Day 1, the participant read the Mixing Instructions Guide on how to mix and administer the medications at home. The participant was given enough time to read and understand the instructions and ask any questions. The participant then completed the SCQ which consists of 7 questions with YES/NO answers, to self-gauge their understanding of drug administration procedures. Reported data represent the number of participants who answered the question YES. Gonadotropins are referred to as investigational medicinal product (IMP). | Intent to treat population for the combination treatment arm only | Posted | Number | participants | Day 1 |
|
|
|
| Secondary | Summary of the Subject Comprehension Questionnaire (SCQ) on Day 6 | Subject comprehension questionnaires were repeated on Day 6 after 5 days of combination therapy by participants assigned to the Menopur and Bravelle treatment arm. The SCQ consists of 7 questions with YES/NO answers to self-gauge participants' understanding of drug administration procedures. Reported data represent the number of participants who answered the question YES. Gonadotropins are referred to as investigational medicinal product (IMP). | Intent to treat population for the combination treatment arm only | Posted | Number | participants | Day 6 |
|
|
|
| Secondary | Summary of Assessor Questionnaire on Day 1 | Participants assigned to the Menopur and Bravelle treatment arm read the Mixing Instructions Guide on how to mix and administer the medications at home. Participants were given enough time to read and understand the instructions and ask any questions. After completing the SCQ, participants prepared and self-administered her assigned first daily dose in the presence of the study coordinator or designee assessor. The assessor then completed a 7 question questionnaire with YES or NO answers to document their assessment of participant understanding of drug administration procedures. Reported data represent the number of participants for whom the assessor answered the question YES. Gonadotropins are referred to as investigational medicinal product (IMP). | Intent to treat population for the combination treatment arm only | Posted | Number | participants | Day 1 |
|
|
|
| Secondary | Summary of Assessor Questionnaire on Day 6 | Participants assigned to the Menopur and Bravelle treatment arm prepared and self-administered her daily dose on Day 6 in the presence of the study coordinator or designee assessor. The assessor then completed a 7 question questionnaire with YES or NO answers to document their assessment of participant understanding of drug administration procedures. Reported data represent the number of participants for whom the assessor answered the question YES. Gonadotropins are referred to as investigational medicinal product (IMP). | Intent to treat population for the combination treatment arm only | Posted | Number | participants | Day 6 |
|
|
|
| Secondary | Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS) | A treatment-emergent AE was any AE occurring after start of investigational medicinal product (IMP) and within the time of residual drug effect, or a pretreatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. The time of residual drug effect was the estimated period of time after the last dose of the IMP, where the effect of the product was still considered to be present based on pharmacokinetic, pharmacodynamic, or other IMP characteristics. | Safety population | Posted | Number | participants | Day 1 up to Day 20 |
|
|
|
| 0 |
| 60 |
| 29 |
| 60 |
| EG001 | Menopur Alone | The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20. | 0 | 62 | 30 | 62 |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Post procedural discomfort | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | MedDRA (14.0) | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA (14.0) | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| Title | Measurements |
|---|---|
|
| How to mix additional vials of IMP in same syringe |
|
| How to inject the IMPs |
|
| How to store the IMPs |
|
| How to dispose of used vials, syringes, needles |
|
| Title | Measurements |
|---|---|
|
| How to mix additional vials of IMP in same syringe |
|
| How to inject the IMPs |
|
| How to store the IMPs |
|
| How to dispose of used vials, syringes, needles |
|
|
| Mixed additional IMP in same syringe correctly |
|
| Injected the IMPs correctly |
|
| Acknowledged understanding of how to store IMPs |
|
| Disposed used vials, syringes, needles correctly |
|
|
| Mixed additional IMP in same syringe correctly |
|
| Injected the IMPs correctly |
|
| Acknowledged understanding of how to store IMPs |
|
| Disposed used vials, syringes, needles correctly |
|
| Severe TEAEs |
|
| Serious TEAEs |
|
| Drug-related Serious TEAEs |
|
| Any TEAEs resulting in study discontinuation |
|
| Participants who died |
|
| Participants with OHSS |
|
| Cycle cancellation due to OHSS |
|