Trial Outcomes & Findings for Menopur Mixed Protocol (NCT NCT01417195)
NCT ID: NCT01417195
Last Updated: 2014-05-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
122 participants
Primary outcome timeframe
approximately day 13 (16-20 hours post insemination by in vitro fertilization (IVF) insemination or intracytoplasmic sperm injection (ICSI))
Results posted on
2014-05-16
Participant Flow
A total of 122 subjects (60 Menopur/Bravelle, 62 Menopur) entered pituitary down-regulation and were randomized in the study.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
62
|
|
Overall Study
COMPLETED
|
57
|
61
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Stimulation failure
|
1
|
0
|
|
Overall Study
No embryos for transfer
|
0
|
1
|
|
Overall Study
No transfer due to risk of OHSS
|
1
|
0
|
|
Overall Study
No transfer due to elevated progesterone
|
1
|
0
|
Baseline Characteristics
Menopur Mixed Protocol
Baseline characteristics by cohort
| Measure |
Menopur and Bravelle Combination
n=60 Participants
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
n=62 Participants
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.
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<35 years
|
35 participants
n=93 Participants
|
40 participants
n=4 Participants
|
75 participants
n=27 Participants
|
|
Age, Customized
35 to 37 years
|
13 participants
n=93 Participants
|
15 participants
n=4 Participants
|
28 participants
n=27 Participants
|
|
Age, Customized
38 to 40 years
|
9 participants
n=93 Participants
|
6 participants
n=4 Participants
|
15 participants
n=27 Participants
|
|
Age, Customized
>40 years
|
3 participants
n=93 Participants
|
1 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=93 Participants
|
62 Participants
n=4 Participants
|
122 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
42 participants
n=93 Participants
|
47 participants
n=4 Participants
|
89 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 participants
n=93 Participants
|
11 participants
n=4 Participants
|
20 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 participants
n=93 Participants
|
4 participants
n=4 Participants
|
13 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 participants
n=93 Participants
|
3 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
54 participants
n=93 Participants
|
59 participants
n=4 Participants
|
113 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=93 Participants
|
62 participants
n=4 Participants
|
122 participants
n=27 Participants
|
|
Body Mass Index
18 to <=25 kg/m^2
|
33 participants
n=93 Participants
|
29 participants
n=4 Participants
|
62 participants
n=27 Participants
|
|
Body Mass Index
>25 to <=30 kg/m^2
|
19 participants
n=93 Participants
|
23 participants
n=4 Participants
|
42 participants
n=27 Participants
|
|
Body Mass Index
>30 to <=35 kg/m^2
|
8 participants
n=93 Participants
|
10 participants
n=4 Participants
|
18 participants
n=27 Participants
|
|
Current Smokers
No
|
56 participants
n=93 Participants
|
57 participants
n=4 Participants
|
113 participants
n=27 Participants
|
|
Current Smokers
Yes
|
4 participants
n=93 Participants
|
5 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Ever Smoked?
No
|
52 participants
n=93 Participants
|
56 participants
n=4 Participants
|
108 participants
n=27 Participants
|
|
Ever Smoked?
Yes
|
8 participants
n=93 Participants
|
6 participants
n=4 Participants
|
14 participants
n=27 Participants
|
|
Current Drinkers
No
|
15 participants
n=93 Participants
|
11 participants
n=4 Participants
|
26 participants
n=27 Participants
|
|
Current Drinkers
Yes
|
45 participants
n=93 Participants
|
51 participants
n=4 Participants
|
96 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: approximately day 13 (16-20 hours post insemination by in vitro fertilization (IVF) insemination or intracytoplasmic sperm injection (ICSI))Population: Intent to treat population
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.
Outcome measures
| Measure |
Menopur and Bravelle Combination
n=60 Participants
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
n=62 Participants
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.
|
|---|---|---|
|
Fertilization Rate
|
63.14 percentage of oocytes retrieved
Standard Deviation 21.567
|
59.56 percentage of oocytes retrieved
Standard Deviation 22.460
|
SECONDARY outcome
Timeframe: Day 1Population: Intent to treat population for the combination treatment arm only
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).
Outcome measures
| Measure |
Menopur and Bravelle Combination
n=60 Participants
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
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.
|
|---|---|---|
|
Summary of the Subject Comprehension Questionnaire (SCQ) on Day 1
How to dispose of used vials, syringes, needles
|
60 participants
|
—
|
|
Summary of the Subject Comprehension Questionnaire (SCQ) on Day 1
Overall mixing instructions
|
60 participants
|
—
|
|
Summary of the Subject Comprehension Questionnaire (SCQ) on Day 1
How to fill the syringe with saline solution
|
60 participants
|
—
|
|
Summary of the Subject Comprehension Questionnaire (SCQ) on Day 1
How to mix the first IMP vial with solution
|
60 participants
|
—
|
|
Summary of the Subject Comprehension Questionnaire (SCQ) on Day 1
How to mix additional vials of IMP in same syringe
|
60 participants
|
—
|
|
Summary of the Subject Comprehension Questionnaire (SCQ) on Day 1
How to inject the IMPs
|
60 participants
|
—
|
|
Summary of the Subject Comprehension Questionnaire (SCQ) on Day 1
How to store the IMPs
|
60 participants
|
—
|
SECONDARY outcome
Timeframe: Day 6Population: Intent to treat population for the combination treatment arm only
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).
Outcome measures
| Measure |
Menopur and Bravelle Combination
n=60 Participants
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
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.
|
|---|---|---|
|
Summary of the Subject Comprehension Questionnaire (SCQ) on Day 6
Overall mixing instructions
|
60 participants
|
—
|
|
Summary of the Subject Comprehension Questionnaire (SCQ) on Day 6
How to fill the syringe with saline solution
|
60 participants
|
—
|
|
Summary of the Subject Comprehension Questionnaire (SCQ) on Day 6
How to mix the first IMP vial with solution
|
60 participants
|
—
|
|
Summary of the Subject Comprehension Questionnaire (SCQ) on Day 6
How to mix additional vials of IMP in same syringe
|
60 participants
|
—
|
|
Summary of the Subject Comprehension Questionnaire (SCQ) on Day 6
How to inject the IMPs
|
60 participants
|
—
|
|
Summary of the Subject Comprehension Questionnaire (SCQ) on Day 6
How to store the IMPs
|
60 participants
|
—
|
|
Summary of the Subject Comprehension Questionnaire (SCQ) on Day 6
How to dispose of used vials, syringes, needles
|
60 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Intent to treat population for the combination treatment arm only
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).
Outcome measures
| Measure |
Menopur and Bravelle Combination
n=60 Participants
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
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.
|
|---|---|---|
|
Summary of Assessor Questionnaire on Day 1
Acknowledged understanding of mixing instructions
|
60 participants
|
—
|
|
Summary of Assessor Questionnaire on Day 1
Filled the syringe with saline solution correctly
|
60 participants
|
—
|
|
Summary of Assessor Questionnaire on Day 1
Mixed the first IMP vial with solution correctly
|
60 participants
|
—
|
|
Summary of Assessor Questionnaire on Day 1
Mixed additional IMP in same syringe correctly
|
60 participants
|
—
|
|
Summary of Assessor Questionnaire on Day 1
Injected the IMPs correctly
|
60 participants
|
—
|
|
Summary of Assessor Questionnaire on Day 1
Acknowledged understanding of how to store IMPs
|
60 participants
|
—
|
|
Summary of Assessor Questionnaire on Day 1
Disposed used vials, syringes, needles correctly
|
60 participants
|
—
|
SECONDARY outcome
Timeframe: Day 6Population: Intent to treat population for the combination treatment arm only
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).
Outcome measures
| Measure |
Menopur and Bravelle Combination
n=60 Participants
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
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.
|
|---|---|---|
|
Summary of Assessor Questionnaire on Day 6
Acknowledged understanding of mixing instructions
|
60 participants
|
—
|
|
Summary of Assessor Questionnaire on Day 6
Filled the syringe with saline solution correctly
|
60 participants
|
—
|
|
Summary of Assessor Questionnaire on Day 6
Mixed the first IMP vial with solution correctly
|
60 participants
|
—
|
|
Summary of Assessor Questionnaire on Day 6
Mixed additional IMP in same syringe correctly
|
60 participants
|
—
|
|
Summary of Assessor Questionnaire on Day 6
Injected the IMPs correctly
|
60 participants
|
—
|
|
Summary of Assessor Questionnaire on Day 6
Acknowledged understanding of how to store IMPs
|
60 participants
|
—
|
|
Summary of Assessor Questionnaire on Day 6
Disposed used vials, syringes, needles correctly
|
60 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to Day 20Population: Safety population
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.
Outcome measures
| Measure |
Menopur and Bravelle Combination
n=60 Participants
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
n=62 Participants
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.
|
|---|---|---|
|
Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS)
Any TEAEs
|
29 participants
|
30 participants
|
|
Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS)
Drug-related TEAEs
|
9 participants
|
13 participants
|
|
Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS)
Severe TEAEs
|
0 participants
|
1 participants
|
|
Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS)
Serious TEAEs
|
0 participants
|
0 participants
|
|
Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS)
Drug-related Serious TEAEs
|
0 participants
|
0 participants
|
|
Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS)
Any TEAEs resulting in study discontinuation
|
0 participants
|
0 participants
|
|
Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS)
Participants who died
|
0 participants
|
0 participants
|
|
Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS)
Participants with OHSS
|
5 participants
|
3 participants
|
|
Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS)
Cycle cancellation due to OHSS
|
0 participants
|
0 participants
|
Adverse Events
Menopur and Bravelle Combination
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Menopur Alone
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Menopur and Bravelle Combination
n=60 participants at risk
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
n=62 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
1.7%
1/60 • Day 1 up to Day 20
|
3.2%
2/62 • Day 1 up to Day 20
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
6/60 • Day 1 up to Day 20
|
9.7%
6/62 • Day 1 up to Day 20
|
|
Gastrointestinal disorders
Constipation
|
3.3%
2/60 • Day 1 up to Day 20
|
4.8%
3/62 • Day 1 up to Day 20
|
|
Gastrointestinal disorders
Nausea
|
3.3%
2/60 • Day 1 up to Day 20
|
8.1%
5/62 • Day 1 up to Day 20
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
3.3%
2/60 • Day 1 up to Day 20
|
4.8%
3/62 • Day 1 up to Day 20
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
5.0%
3/60 • Day 1 up to Day 20
|
9.7%
6/62 • Day 1 up to Day 20
|
|
Injury, poisoning and procedural complications
Procedural pain
|
20.0%
12/60 • Day 1 up to Day 20
|
19.4%
12/62 • Day 1 up to Day 20
|
|
Nervous system disorders
Headache
|
3.3%
2/60 • Day 1 up to Day 20
|
6.5%
4/62 • Day 1 up to Day 20
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
8.3%
5/60 • Day 1 up to Day 20
|
4.8%
3/62 • Day 1 up to Day 20
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.7%
1/60 • Day 1 up to Day 20
|
3.2%
2/62 • Day 1 up to Day 20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER