Trial Outcomes & Findings for A Dose-response Trial Using rFSH FE 999049 in Women Undergoing IVF/ICSI Treatment (NCT NCT01426386)
NCT ID: NCT01426386
Last Updated: 2020-11-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
265 participants
Primary outcome timeframe
Day of oocyte retrieval (up to Day 18 after start of stimulation)
Results posted on
2020-11-17
Participant Flow
A total of 7 sites randomised subjects to the trial: 1 in Belgium, 1 in Czech Republic, 1 in Denmark and 4 in Spain.
In total 334 subjects were screened. Of these, 69 were screening failures and 265 were randomised. All randomised subjects were exposed to investigational medicinal product (IMP).
Participant milestones
| Measure |
FE 999049 5.2 µg
Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days
|
FE 999049 6.9 µg
Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days
|
FE 999049 8.6 µg
Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days
|
FE 999049 10.3 µg
Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days
|
FE 999049 12.1 µg
Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days
|
GONAL-F 11 µg
Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
42
|
45
|
44
|
44
|
47
|
43
|
|
Overall Study
COMPLETED
|
39
|
39
|
42
|
44
|
43
|
42
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
2
|
0
|
4
|
1
|
Reasons for withdrawal
| Measure |
FE 999049 5.2 µg
Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days
|
FE 999049 6.9 µg
Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days
|
FE 999049 8.6 µg
Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days
|
FE 999049 10.3 µg
Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days
|
FE 999049 12.1 µg
Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days
|
GONAL-F 11 µg
Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Did not attend scheduled visit
|
1
|
4
|
0
|
0
|
2
|
1
|
|
Overall Study
Poor response
|
2
|
1
|
2
|
0
|
1
|
0
|
|
Overall Study
Personal reasons
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Dose-response Trial Using rFSH FE 999049 in Women Undergoing IVF/ICSI Treatment
Baseline characteristics by cohort
| Measure |
FE 999049 5.2 µg
n=42 Participants
Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days
|
FE 999049 6.9 µg
n=45 Participants
Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days
|
FE 999049 8.6 µg
n=44 Participants
Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days
|
FE 999049 10.3 µg
n=44 Participants
Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days
|
FE 999049 12.1 µg
n=47 Participants
Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days
|
GONAL-F 11 µg
n=43 Participants
Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days
|
Total
n=265 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.6 years
STANDARD_DEVIATION 2.24 • n=93 Participants
|
32.3 years
STANDARD_DEVIATION 3.51 • n=4 Participants
|
32.8 years
STANDARD_DEVIATION 2.44 • n=27 Participants
|
32.3 years
STANDARD_DEVIATION 3.21 • n=483 Participants
|
32.6 years
STANDARD_DEVIATION 2.97 • n=36 Participants
|
32.4 years
STANDARD_DEVIATION 3.04 • n=10 Participants
|
32.7 years
STANDARD_DEVIATION 2.95 • n=115 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
44 Participants
n=483 Participants
|
47 Participants
n=36 Participants
|
43 Participants
n=10 Participants
|
265 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Day of oocyte retrieval (up to Day 18 after start of stimulation)Population: Modified Intention-to-treat (mITT) population (all randomised and exposed subjects). This is equivalent to the Full Analysis Set (FAS)
Outcome measures
| Measure |
FE 999049 5.2 µg
n=42 Participants
Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days
|
FE 999049 6.9 µg
n=45 Participants
Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days
|
FE 999049 8.6 µg
n=44 Participants
Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days
|
FE 999049 10.3 µg
n=44 Participants
Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days
|
FE 999049 12.1 µg
n=47 Participants
Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days
|
GONAL-F 11 µg
n=43 Participants
Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days
|
|---|---|---|---|---|---|---|
|
Number of Oocytes Retrieved
|
5.2 Oocytes
Standard Deviation 3.3
|
7.9 Oocytes
Standard Deviation 5.9
|
9.2 Oocytes
Standard Deviation 4.6
|
10.5 Oocytes
Standard Deviation 7.0
|
12.2 Oocytes
Standard Deviation 5.9
|
10.4 Oocytes
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: End of stimulation (up to 16 stimulation days)Population: mITT population (all randomised and exposed subjects). This is equivalent to the FAS
Follicular volume at end of stimulation
Outcome measures
| Measure |
FE 999049 5.2 µg
n=42 Participants
Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days
|
FE 999049 6.9 µg
n=45 Participants
Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days
|
FE 999049 8.6 µg
n=44 Participants
Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days
|
FE 999049 10.3 µg
n=44 Participants
Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days
|
FE 999049 12.1 µg
n=47 Participants
Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days
|
GONAL-F 11 µg
n=43 Participants
Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days
|
|---|---|---|---|---|---|---|
|
Number and Size of Follicles During Stimulation
|
19.2 cm^3
Standard Deviation 7.0
|
23.0 cm^3
Standard Deviation 10.5
|
25.0 cm^3
Standard Deviation 9.2
|
27.9 cm^3
Standard Deviation 15.6
|
28.2 cm^3
Standard Deviation 9.5
|
26.7 cm^3
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: End of stimulation (up to 16 stimulation days)Population: mITT population (all randomised and exposed subjects). This is equivalent to the FAS
Estradiol at end of stimulation
Outcome measures
| Measure |
FE 999049 5.2 µg
n=42 Participants
Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days
|
FE 999049 6.9 µg
n=45 Participants
Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days
|
FE 999049 8.6 µg
n=44 Participants
Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days
|
FE 999049 10.3 µg
n=44 Participants
Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days
|
FE 999049 12.1 µg
n=47 Participants
Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days
|
GONAL-F 11 µg
n=43 Participants
Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days
|
|---|---|---|---|---|---|---|
|
Endocrine Profile
|
3641.9 pmol/L
Standard Deviation 2954.6
|
5221.1 pmol/L
Standard Deviation 3378.8
|
5689.5 pmol/L
Standard Deviation 3995.7
|
6171.8 pmol/L
Standard Deviation 3855.9
|
6442.0 pmol/L
Standard Deviation 3195.2
|
5750.7 pmol/L
Standard Deviation 3709.7
|
SECONDARY outcome
Timeframe: End of stimulation (up to 16 stimulation days)Population: mITT population (all randomised and exposed subjects). This is equivalent to the FAS
Outcome measures
| Measure |
FE 999049 5.2 µg
n=42 Participants
Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days
|
FE 999049 6.9 µg
n=45 Participants
Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days
|
FE 999049 8.6 µg
n=44 Participants
Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days
|
FE 999049 10.3 µg
n=44 Participants
Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days
|
FE 999049 12.1 µg
n=47 Participants
Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days
|
GONAL-F 11 µg
n=43 Participants
Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days
|
|---|---|---|---|---|---|---|
|
Total IMP Dose
|
50.0 µg
Standard Deviation 11.6
|
61.9 µg
Standard Deviation 13.7
|
71.9 µg
Standard Deviation 14.1
|
81.0 µg
Standard Deviation 14.2
|
97.8 µg
Standard Deviation 22.0
|
94.7 µg
Standard Deviation 18.1
|
SECONDARY outcome
Timeframe: Day 1 after inseminationPopulation: Subjects with oocytes retrieved
An oocyte with 2 pronuclei was regarded as correctly fertilised
Outcome measures
| Measure |
FE 999049 5.2 µg
n=42 Participants
Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days
|
FE 999049 6.9 µg
n=45 Participants
Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days
|
FE 999049 8.6 µg
n=44 Participants
Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days
|
FE 999049 10.3 µg
n=44 Participants
Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days
|
FE 999049 12.1 µg
n=47 Participants
Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days
|
GONAL-F 11 µg
n=43 Participants
Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days
|
|---|---|---|---|---|---|---|
|
Number of Fertilised Oocytes
|
3.7 Fertilised oocytes
Standard Deviation 2.5
|
5.4 Fertilised oocytes
Standard Deviation 3.8
|
4.9 Fertilised oocytes
Standard Deviation 2.7
|
6.1 Fertilised oocytes
Standard Deviation 5.1
|
6.7 Fertilised oocytes
Standard Deviation 3.5
|
6.4 Fertilised oocytes
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Day 5 after oocyte retrievalPopulation: Subjects with oocytes retrieved
Number of blastocysts (total and good-quality) on Day 5 are presented. A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher
Outcome measures
| Measure |
FE 999049 5.2 µg
n=42 Participants
Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days
|
FE 999049 6.9 µg
n=45 Participants
Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days
|
FE 999049 8.6 µg
n=44 Participants
Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days
|
FE 999049 10.3 µg
n=44 Participants
Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days
|
FE 999049 12.1 µg
n=47 Participants
Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days
|
GONAL-F 11 µg
n=43 Participants
Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days
|
|---|---|---|---|---|---|---|
|
Number and Quality of Blastocysts on Day 5
Total blastocysts
|
2.3 Blastocysts
Standard Deviation 1.7
|
3.1 Blastocysts
Standard Deviation 2.7
|
2.7 Blastocysts
Standard Deviation 2.0
|
2.8 Blastocysts
Standard Deviation 2.8
|
3.2 Blastocysts
Standard Deviation 2.2
|
3.5 Blastocysts
Standard Deviation 2.5
|
|
Number and Quality of Blastocysts on Day 5
Good quality blastocysts
|
0.9 Blastocysts
Standard Deviation 1.2
|
1.4 Blastocysts
Standard Deviation 1.7
|
1.2 Blastocysts
Standard Deviation 1.2
|
1.4 Blastocysts
Standard Deviation 1.5
|
1.3 Blastocysts
Standard Deviation 1.3
|
1.6 Blastocysts
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 5-6 weeks after transferPopulation: mITT population (all randomised and exposed subjects). This is equivalent to the FAS
Clinical pregnancy with fetal heart beat was defined as at least one intrauterine gestational sac with fetal heart beat
Outcome measures
| Measure |
FE 999049 5.2 µg
n=42 Participants
Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days
|
FE 999049 6.9 µg
n=45 Participants
Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days
|
FE 999049 8.6 µg
n=44 Participants
Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days
|
FE 999049 10.3 µg
n=44 Participants
Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days
|
FE 999049 12.1 µg
n=47 Participants
Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days
|
GONAL-F 11 µg
n=43 Participants
Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days
|
|---|---|---|---|---|---|---|
|
Clinical Pregnancy With Fetal Heart Beat Rate
|
36 percentage
Interval 21.6 to 52.0
|
40 percentage
Interval 25.7 to 55.7
|
36 percentage
Interval 22.4 to 52.2
|
25 percentage
Interval 13.2 to 40.3
|
40 percentage
Interval 26.4 to 55.7
|
51 percentage
Interval 35.5 to 66.7
|
SECONDARY outcome
Timeframe: From signing informed consent form until end of trial visit (up to 5 months)Population: Safety population (all randomised and exposed subjects). This is equivalent to the mITT
Outcome measures
| Measure |
FE 999049 5.2 µg
n=42 Participants
Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days
|
FE 999049 6.9 µg
n=45 Participants
Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days
|
FE 999049 8.6 µg
n=44 Participants
Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days
|
FE 999049 10.3 µg
n=44 Participants
Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days
|
FE 999049 12.1 µg
n=47 Participants
Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days
|
GONAL-F 11 µg
n=43 Participants
Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days
|
|---|---|---|---|---|---|---|
|
Frequency and Intensity of Adverse Events
Any mild adverse events
|
15 participants
|
17 participants
|
17 participants
|
18 participants
|
15 participants
|
11 participants
|
|
Frequency and Intensity of Adverse Events
Any moderate adverse events
|
2 participants
|
6 participants
|
5 participants
|
9 participants
|
8 participants
|
2 participants
|
|
Frequency and Intensity of Adverse Events
Any severe adverse events
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
Adverse Events
FE 999049 5.2 µg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
FE 999049 6.9 µg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
FE 999049 8.6 µg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
FE 999049 10.3 µg
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
FE 999049 12.1 µg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
GONAL-F 11 µg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FE 999049 5.2 µg
n=42 participants at risk
Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days
|
FE 999049 6.9 µg
n=45 participants at risk
Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days
|
FE 999049 8.6 µg
n=44 participants at risk
Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days
|
FE 999049 10.3 µg
n=44 participants at risk
Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days
|
FE 999049 12.1 µg
n=47 participants at risk
Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days
|
GONAL-F 11 µg
n=43 participants at risk
Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days
|
|---|---|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/42 • From signing informed consent form until the end of trial visit (up to 5 months)
|
0.00%
0/45 • From signing informed consent form until the end of trial visit (up to 5 months)
|
0.00%
0/44 • From signing informed consent form until the end of trial visit (up to 5 months)
|
2.3%
1/44 • Number of events 1 • From signing informed consent form until the end of trial visit (up to 5 months)
|
0.00%
0/47 • From signing informed consent form until the end of trial visit (up to 5 months)
|
0.00%
0/43 • From signing informed consent form until the end of trial visit (up to 5 months)
|
Other adverse events
| Measure |
FE 999049 5.2 µg
n=42 participants at risk
Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days
|
FE 999049 6.9 µg
n=45 participants at risk
Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days
|
FE 999049 8.6 µg
n=44 participants at risk
Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days
|
FE 999049 10.3 µg
n=44 participants at risk
Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days
|
FE 999049 12.1 µg
n=47 participants at risk
Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days
|
GONAL-F 11 µg
n=43 participants at risk
Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.8%
2/42 • Number of events 2 • From signing informed consent form until the end of trial visit (up to 5 months)
|
0.00%
0/45 • From signing informed consent form until the end of trial visit (up to 5 months)
|
0.00%
0/44 • From signing informed consent form until the end of trial visit (up to 5 months)
|
2.3%
1/44 • Number of events 1 • From signing informed consent form until the end of trial visit (up to 5 months)
|
8.5%
4/47 • Number of events 4 • From signing informed consent form until the end of trial visit (up to 5 months)
|
0.00%
0/43 • From signing informed consent form until the end of trial visit (up to 5 months)
|
|
Nervous system disorders
Headache
|
9.5%
4/42 • Number of events 4 • From signing informed consent form until the end of trial visit (up to 5 months)
|
8.9%
4/45 • Number of events 4 • From signing informed consent form until the end of trial visit (up to 5 months)
|
11.4%
5/44 • Number of events 5 • From signing informed consent form until the end of trial visit (up to 5 months)
|
6.8%
3/44 • Number of events 4 • From signing informed consent form until the end of trial visit (up to 5 months)
|
2.1%
1/47 • Number of events 1 • From signing informed consent form until the end of trial visit (up to 5 months)
|
2.3%
1/43 • Number of events 1 • From signing informed consent form until the end of trial visit (up to 5 months)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
7.1%
3/42 • Number of events 3 • From signing informed consent form until the end of trial visit (up to 5 months)
|
11.1%
5/45 • Number of events 5 • From signing informed consent form until the end of trial visit (up to 5 months)
|
4.5%
2/44 • Number of events 2 • From signing informed consent form until the end of trial visit (up to 5 months)
|
11.4%
5/44 • Number of events 5 • From signing informed consent form until the end of trial visit (up to 5 months)
|
10.6%
5/47 • Number of events 5 • From signing informed consent form until the end of trial visit (up to 5 months)
|
2.3%
1/43 • Number of events 1 • From signing informed consent form until the end of trial visit (up to 5 months)
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
4.8%
2/42 • Number of events 2 • From signing informed consent form until the end of trial visit (up to 5 months)
|
2.2%
1/45 • Number of events 1 • From signing informed consent form until the end of trial visit (up to 5 months)
|
9.1%
4/44 • Number of events 4 • From signing informed consent form until the end of trial visit (up to 5 months)
|
6.8%
3/44 • Number of events 4 • From signing informed consent form until the end of trial visit (up to 5 months)
|
4.3%
2/47 • Number of events 2 • From signing informed consent form until the end of trial visit (up to 5 months)
|
2.3%
1/43 • Number of events 1 • From signing informed consent form until the end of trial visit (up to 5 months)
|
|
Reproductive system and breast disorders
Pelvic pain
|
4.8%
2/42 • Number of events 2 • From signing informed consent form until the end of trial visit (up to 5 months)
|
0.00%
0/45 • From signing informed consent form until the end of trial visit (up to 5 months)
|
2.3%
1/44 • Number of events 1 • From signing informed consent form until the end of trial visit (up to 5 months)
|
6.8%
3/44 • Number of events 3 • From signing informed consent form until the end of trial visit (up to 5 months)
|
4.3%
2/47 • Number of events 2 • From signing informed consent form until the end of trial visit (up to 5 months)
|
4.7%
2/43 • Number of events 2 • From signing informed consent form until the end of trial visit (up to 5 months)
|
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