Trial Outcomes & Findings for Rekovelle PK Trial in Chinese Women (NCT NCT04150861)
NCT ID: NCT04150861
Last Updated: 2023-02-14
Results Overview
Area under the concentration-time curve from dosing to infinity.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdose
Results posted on
2023-02-14
Participant Flow
The trial was conducted at one site in China between June 2019 to December 2019.
A total of 133 subjects were screened, wherein, 24 subjects met the eligibility criteria and were randomized to the investigational medicinal product (IMP): 8 subjects each were exposed to Follitropin Delta (FE 999049) 12 μg, 18 μg and 24 μg, respectively. All the randomized subjects completed the trial.
Participant milestones
| Measure |
Follitropin Delta (FE 999049) 12 μg
Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 18 μg
Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 24 μg
Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rekovelle PK Trial in Chinese Women
Baseline characteristics by cohort
| Measure |
Follitropin Delta (FE 999049) 12 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 18 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 24 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28.6 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
29.5 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
25.4 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
27.8 years
STANDARD_DEVIATION 5.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Body Mass Index (BMI)
|
22.2 kg/m^2
STANDARD_DEVIATION 1.6 • n=5 Participants
|
20.7 kg/m^2
STANDARD_DEVIATION 1.9 • n=7 Participants
|
22.0 kg/m^2
STANDARD_DEVIATION 2.3 • n=5 Participants
|
21.6 kg/m^2
STANDARD_DEVIATION 2.0 • n=4 Participants
|
PRIMARY outcome
Timeframe: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdosePopulation: The per-protocol (PP) analysis set comprised data from all dosed subjects except data excluded as a result of major protocol deviations. Subjects were analyzed according to the actual dose received.
Area under the concentration-time curve from dosing to infinity.
Outcome measures
| Measure |
Follitropin Delta (FE 999049) 12 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 18 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 24 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period.
|
|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Dosing to Infinity (AUC)
|
41.3 h*ng/mL
Geometric Coefficient of Variation 44.3
|
62.9 h*ng/mL
Geometric Coefficient of Variation 19.7
|
83.1 h*ng/mL
Geometric Coefficient of Variation 36.6
|
PRIMARY outcome
Timeframe: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdosePopulation: The PP analysis set comprised data from all dosed subjects except data excluded as a result of major protocol deviations. Subjects were analyzed according to the actual dose received.
AUCt is defined as the area under the serum concentration-time curve from dosing up to time t, where t is the last time point at which the concentration is above the lower limit of quantification.
Outcome measures
| Measure |
Follitropin Delta (FE 999049) 12 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 18 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 24 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period.
|
|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Dosing up to Time t (AUCt)
|
36.4 h*ng/mL
Geometric Coefficient of Variation 38.0
|
56.6 h*ng/mL
Geometric Coefficient of Variation 18.7
|
74.6 h*ng/mL
Geometric Coefficient of Variation 35.9
|
PRIMARY outcome
Timeframe: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdosePopulation: The PP analysis set comprised data from all dosed subjects except data excluded as a result of major protocol deviations. Subjects were analyzed according to the actual dose received.
Maximum concentration observed in serum.
Outcome measures
| Measure |
Follitropin Delta (FE 999049) 12 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 18 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 24 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period.
|
|---|---|---|---|
|
Maximum Serum Concentration Observed (Cmax)
|
0.388 ng/mL
Geometric Coefficient of Variation 26.5
|
0.677 ng/mL
Geometric Coefficient of Variation 29.1
|
0.825 ng/mL
Geometric Coefficient of Variation 34.6
|
PRIMARY outcome
Timeframe: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdosePopulation: The PP analysis set comprised data from all dosed subjects except data excluded as a result of major protocol deviations. Subjects were analyzed according to the actual dose received.
Time of maximum observed concentration in serum.
Outcome measures
| Measure |
Follitropin Delta (FE 999049) 12 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 18 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 24 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period.
|
|---|---|---|---|
|
Time of Maximum Observed Serum Concentration (Tmax)
|
24.0 hour
Interval 16.0 to 36.0
|
24.0 hour
Interval 16.0 to 48.0
|
24.0 hour
Interval 24.0 to 28.0
|
PRIMARY outcome
Timeframe: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdosePopulation: The PP analysis set comprised data from all dosed subjects except data excluded as a result of major protocol deviations. Subjects were analyzed according to the actual dose received.
Outcome measures
| Measure |
Follitropin Delta (FE 999049) 12 μg
n=7 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 18 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 24 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period.
|
|---|---|---|---|
|
Apparent Total Systemic Clearance (CL/F)
|
0.301 Liter/hour
Geometric Coefficient of Variation 46.6
|
0.286 Liter/hour
Geometric Coefficient of Variation 19.7
|
0.289 Liter/hour
Geometric Coefficient of Variation 36.6
|
PRIMARY outcome
Timeframe: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdosePopulation: The PP analysis set comprised data from all dosed subjects except data excluded as a result of major protocol deviations. Subjects were analyzed according to the actual dose received.
Outcome measures
| Measure |
Follitropin Delta (FE 999049) 12 μg
n=7 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 18 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 24 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period.
|
|---|---|---|---|
|
Apparent Volume of Distribution Associated With the Terminal Phase (VZ/F)
|
25.5 Liter
Geometric Coefficient of Variation 19.5
|
20.8 Liter
Geometric Coefficient of Variation 43.5
|
25.4 Liter
Geometric Coefficient of Variation 31.5
|
PRIMARY outcome
Timeframe: At -1, -0.5 and 0 hour predose, and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48 hours, and 3, 4, 5, 6, 7, 8, and 9 days postdosePopulation: The PP analysis set comprised data from all dosed subjects except data excluded as a result of major protocol deviations. Subjects were analyzed according to the actual dose received.
Outcome measures
| Measure |
Follitropin Delta (FE 999049) 12 μg
n=7 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 18 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 24 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period.
|
|---|---|---|---|
|
Terminal Elimination Half-life (t½)
|
58.6 hour
Geometric Coefficient of Variation 47.5
|
50.5 hour
Geometric Coefficient of Variation 43.5
|
60.9 hour
Geometric Coefficient of Variation 13.6
|
SECONDARY outcome
Timeframe: At screening, on Day -1, at 12, 24, 48 hours postdose, and at the follow-up visit (Day 11)Population: The safety analysis set comprised data from all dosed subjects and was used for safety analysis. The safety analysis set was identical to the FAS.
Number of participants with clinically significant abnormal changes in ECG are presented.
Outcome measures
| Measure |
Follitropin Delta (FE 999049) 12 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 18 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 24 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Changes in Electrocardiogram (ECG)
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At screening, on Day -1, at 12, 24, 48 hours postdose, and at the follow-up visit (Day 11)Population: The safety analysis set comprised data from all dosed subjects and was used for safety analysis. The safety analysis set was identical to the FAS.
Number of participants with clinically significant abnormal changes in vital signs (systemic blood pressures, heart rate and body temperature) are presented.
Outcome measures
| Measure |
Follitropin Delta (FE 999049) 12 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 18 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 24 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Changes in Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At screening, on Day -1 and Day 3, and at the follow-up visit (Day 11)Population: The safety analysis set comprised data from all dosed subjects and was used for safety analysis. The safety analysis set was identical to the FAS.
Number of participants with clinically significant abnormal findings in laboratory parameters (clinical chemistry, haematology, urinalysis) are presented.
Outcome measures
| Measure |
Follitropin Delta (FE 999049) 12 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 18 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 24 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Findings in Laboratory Parameters
Clinical Chemistry
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Abnormal Findings in Laboratory Parameters
Haematology
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormal Findings in Laboratory Parameters
Urinalysis
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From signed informed consent until the end-of-trial visit (Day 28)Population: The safety analysis set comprised data from all dosed subjects and was used for safety analysis. The safety analysis set was identical to the FAS.
An AE is any untoward medical occurrence in a participant participating in a clinical trial. Number of participants with any AE (serious or non-serious) and type of AEs ( mild, moderate, severe) are presented.
Outcome measures
| Measure |
Follitropin Delta (FE 999049) 12 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 18 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 24 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Type of AEs
Adverse events (AEs)
|
5 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs) and Type of AEs
Serious AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Type of AEs
Severe AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Type of AEs
Mild AEs
|
5 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs) and Type of AEs
Moderate AEs
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immediately, 30 minutes, and 24 hours after administrationPopulation: The safety analysis set comprised data from all dosed subjects and was used for safety analysis. The safety analysis set was identical to the FAS.
The injection site reactions (redness, pain, itching, swelling, and bruising) will be assessed by the investigator after injection, 30 minutes, and 24 hours after administration of the IMP. Each injection site reaction will be assessed as none, mild, moderate, or severe.
Outcome measures
| Measure |
Follitropin Delta (FE 999049) 12 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 18 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 24 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period.
|
|---|---|---|---|
|
Frequency of Injection Site Reactions
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: On Day 1 predose, Day 7, and Day 28Population: The safety analysis set comprised data from all dosed subjects and was used for safety analysis. The safety analysis set was identical to the FAS.
Outcome measures
| Measure |
Follitropin Delta (FE 999049) 12 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 18 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 24 μg
n=8 Participants
Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period.
|
|---|---|---|---|
|
Number of Participants With Treatment-induced Anti-follicle-stimulating Hormone (Anti-FSH) Antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Follitropin Delta (FE 999049) 12 μg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Follitropin Delta (FE 999049) 18 μg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Follitropin Delta (FE 999049) 24 μg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Follitropin Delta (FE 999049) 12 μg
n=8 participants at risk
Participants received single subcutaneous abdominal injection of Follitropin Delta 12 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 18 μg
n=8 participants at risk
Participants received single subcutaneous abdominal injection of Follitropin Delta 18 μg on Day 1 of the Treatment Period.
|
Follitropin Delta (FE 999049) 24 μg
n=8 participants at risk
Participants received single subcutaneous abdominal injection of Follitropin Delta 24 μg on Day 1 of the Treatment Period.
|
|---|---|---|---|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
12.5%
1/8 • Number of events 1 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
12.5%
1/8 • Number of events 1 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • Number of events 1 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
12.5%
1/8 • Number of events 1 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Number of events 1 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
12.5%
1/8 • Number of events 1 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
|
Investigations
Blood urine present
|
12.5%
1/8 • Number of events 1 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
12.5%
1/8 • Number of events 1 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
12.5%
1/8 • Number of events 1 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
12.5%
1/8 • Number of events 1 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
|
Investigations
Smear cervix abnormal
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
12.5%
1/8 • Number of events 1 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
12.5%
1/8 • Number of events 1 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
|
Nervous system disorders
Poor quality sleep
|
12.5%
1/8 • Number of events 1 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
12.5%
1/8 • Number of events 1 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
12.5%
1/8 • Number of events 1 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • Number of events 1 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
12.5%
1/8 • Number of events 1 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
0.00%
0/8 • From signed informed consent until the end-of-trial visit (Day 28)
A treatment-emergent AE was any AE occurring after administration of IMP and within the time of residual drug effect, or a pre-treatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. Only treatment-emergent AEs are presented.
|
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