Trial Outcomes & Findings for LutrePulse Hypogonadotropic Hypogonadism (NCT NCT01976728)
NCT ID: NCT01976728
Last Updated: 2021-03-03
Results Overview
Calculated as a proportion of subjects with at least 1 post-baseline progesterone level ≥ 6 ng/mL or subjects with confirmed positive serum β-human chorionic gonadotropin (β-hCG) (i.e., 2 positive results) or subjects with a gestational sac documented by transvaginal ultrasound (TVUS).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
39 participants
Primary outcome timeframe
From treatment Day 1 up to 4 weeks after second positive β-hCG test, approximately 9 weeks
Results posted on
2021-03-03
Participant Flow
A total of 24 sites randomized subjects to the trial between April 2014 and February 2018. The trial sites that randomized subjects to the trial were: 22 in the United States of America and 2 in Canada.
A total of 54 subjects were screened, of which 39 subjects were randomized. Of the 39 randomized subjects, 10 were randomized to LutrePulse 10 μg/pulse, 9 were randomized to LutrePulse 15 μg/pulse, 10 were randomized to LutrePulse 20 μg/pulse and 10 were randomized to placebo.
Participant milestones
| Measure |
LutrePulse 10 µg/Pulse
Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 15 µg/Pulse
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 20 µg/Pulse
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
|
Placebo
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
10
|
10
|
|
Overall Study
Dosed
|
10
|
9
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
9
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
LutrePulse 10 µg/Pulse
Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 15 µg/Pulse
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 20 µg/Pulse
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
|
Placebo
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
|
|---|---|---|---|---|
|
Overall Study
Subject missed multiple doses of IMP
|
1
|
0
|
0
|
0
|
Baseline Characteristics
LutrePulse Hypogonadotropic Hypogonadism
Baseline characteristics by cohort
| Measure |
LutrePulse 10 µg/Pulse
n=10 Participants
Gonadorelin acetate SC 10 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 15 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 20 µg/Pulse
n=10 Participants
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
|
Placebo
n=10 Participants
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30.9 years
STANDARD_DEVIATION 4.20 • n=5 Participants
|
29.6 years
STANDARD_DEVIATION 6.02 • n=7 Participants
|
30.9 years
STANDARD_DEVIATION 5.67 • n=5 Participants
|
29.5 years
STANDARD_DEVIATION 2.55 • n=4 Participants
|
30.2 years
STANDARD_DEVIATION 4.63 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
39 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
30 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
31 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
BMI
|
29.41 kg/m^2
STANDARD_DEVIATION 6.065 • n=5 Participants
|
23.70 kg/m^2
STANDARD_DEVIATION 4.567 • n=7 Participants
|
26.53 kg/m^2
STANDARD_DEVIATION 4.218 • n=5 Participants
|
23.85 kg/m^2
STANDARD_DEVIATION 3.953 • n=4 Participants
|
25.93 kg/m^2
STANDARD_DEVIATION 5.159 • n=21 Participants
|
PRIMARY outcome
Timeframe: From treatment Day 1 up to 4 weeks after second positive β-hCG test, approximately 9 weeksPopulation: The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9).
Calculated as a proportion of subjects with at least 1 post-baseline progesterone level ≥ 6 ng/mL or subjects with confirmed positive serum β-human chorionic gonadotropin (β-hCG) (i.e., 2 positive results) or subjects with a gestational sac documented by transvaginal ultrasound (TVUS).
Outcome measures
| Measure |
LutrePulse 10 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 10 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 15 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 20 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
|
Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled
n=18 Participants
Gonadorelin acetate SC 15 μg/pulse and SC 20 μg/pulse, administered via. OmniPod pump pooled
|
Placebo
n=10 Participants
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
|
|---|---|---|---|---|---|
|
Ovulation Rate
|
1 Participants
|
4 Participants
|
5 Participants
|
9 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Treatment Days 19, 21, 23, 25, and 27Population: The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9).
Proportion of participants with at least 1 post-baseline P4 level ≥ 10 ng/mL.
Outcome measures
| Measure |
LutrePulse 10 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 10 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 15 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 20 µg/Pulse
n=10 Participants
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
|
Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled
n=19 Participants
Gonadorelin acetate SC 15 μg/pulse and SC 20 μg/pulse, administered via. OmniPod pump pooled
|
Placebo
n=10 Participants
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
|
|---|---|---|---|---|---|
|
Progesterone (P4) Levels
|
1 Participants
|
4 Participants
|
3 Participants
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 to 4 weeks after a second positive serum β-hCG testPopulation: The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9).
Proportion of subjects with presence of gestational sac and fetal heart movement on TVUS after a second positive serum β-hCG test.
Outcome measures
| Measure |
LutrePulse 10 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 10 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 15 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 20 µg/Pulse
n=10 Participants
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
|
Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled
n=19 Participants
Gonadorelin acetate SC 15 μg/pulse and SC 20 μg/pulse, administered via. OmniPod pump pooled
|
Placebo
n=10 Participants
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
|
|---|---|---|---|---|---|
|
Clinical Pregnancy Rate
|
0 Participants
|
2 Participants
|
5 Participants
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximately 14 days after LH surgePopulation: The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9).
Proportion of subjects with a confirmed positive serum β-hCG test after luteinizing hormone (LH) surge.
Outcome measures
| Measure |
LutrePulse 10 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 10 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 15 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 20 µg/Pulse
n=10 Participants
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
|
Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled
n=19 Participants
Gonadorelin acetate SC 15 μg/pulse and SC 20 μg/pulse, administered via. OmniPod pump pooled
|
Placebo
n=10 Participants
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
|
|---|---|---|---|---|---|
|
Biochemical Pregnancy Rate
|
0 Participants
|
3 Participants
|
5 Participants
|
8 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Daily from Day 11 until first positive LH surge or until Day 39Population: The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9).
Proportion of subjects with a positive detection of LH surge, based on a Clearblue test which began when follicles with a mean diameter ≥14 mm were documented on TVUS.
Outcome measures
| Measure |
LutrePulse 10 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 10 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 15 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 20 µg/Pulse
n=10 Participants
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
|
Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled
n=19 Participants
Gonadorelin acetate SC 15 μg/pulse and SC 20 μg/pulse, administered via. OmniPod pump pooled
|
Placebo
n=10 Participants
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
|
|---|---|---|---|---|---|
|
LH Surge Detection
|
3 Participants
|
7 Participants
|
6 Participants
|
13 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From treatment Day 10 to treatment Day 21Population: The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9).
Number of follicles with a mean diameter ≥14 mm collected from Days 10 or 11, until LH surge or Day 21.
Outcome measures
| Measure |
LutrePulse 10 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 10 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 15 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 20 µg/Pulse
n=10 Participants
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
|
Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled
n=10 Participants
Gonadorelin acetate SC 15 μg/pulse and SC 20 μg/pulse, administered via. OmniPod pump pooled
|
Placebo
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
|
|---|---|---|---|---|---|
|
Ovarian Follicular Development: Number of Follicles With a Mean Diameter Greater Than or Equal to (≥)14 mm
Day 10
|
0.0 follicles
Interval 0.0 to 2.0
|
0.0 follicles
Interval 0.0 to 1.0
|
0.0 follicles
Interval 0.0 to 1.0
|
0.0 follicles
Interval 0.0 to 0.0
|
—
|
|
Ovarian Follicular Development: Number of Follicles With a Mean Diameter Greater Than or Equal to (≥)14 mm
Day 12
|
0.0 follicles
Interval 0.0 to 1.0
|
0.5 follicles
Interval 0.0 to 1.0
|
0.0 follicles
Interval 0.0 to 1.0
|
0.0 follicles
Interval 0.0 to 0.0
|
—
|
|
Ovarian Follicular Development: Number of Follicles With a Mean Diameter Greater Than or Equal to (≥)14 mm
Day 15
|
0.0 follicles
Interval 0.0 to 1.0
|
0.0 follicles
Interval 0.0 to 1.0
|
0.0 follicles
Interval 0.0 to 1.0
|
0.0 follicles
Interval 0.0 to 0.0
|
—
|
|
Ovarian Follicular Development: Number of Follicles With a Mean Diameter Greater Than or Equal to (≥)14 mm
Day 18
|
0.0 follicles
Interval 0.0 to 1.0
|
1.0 follicles
Interval 0.0 to 1.0
|
1.0 follicles
Interval 0.0 to 2.0
|
0.0 follicles
Interval 0.0 to 0.0
|
—
|
|
Ovarian Follicular Development: Number of Follicles With a Mean Diameter Greater Than or Equal to (≥)14 mm
Day 21
|
0.0 follicles
Interval 0.0 to 0.0
|
0.0 follicles
Interval 0.0 to 0.0
|
0.0 follicles
Interval 0.0 to 1.0
|
0.0 follicles
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: From treatment Day 10 to treatment Day 21Population: The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9).
Number of dominant follicles with a mean diameter ≥18 mm collected from Days 10 or 11, until LH surge or Day 21.
Outcome measures
| Measure |
LutrePulse 10 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 10 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 15 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 20 µg/Pulse
n=10 Participants
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
|
Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled
n=10 Participants
Gonadorelin acetate SC 15 μg/pulse and SC 20 μg/pulse, administered via. OmniPod pump pooled
|
Placebo
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
|
|---|---|---|---|---|---|
|
Ovarian Follicular Development: Number of Dominant Follicles With a Mean Diameter of ≥18 mm
Day 10
|
0.0 follicles
Interval 0.0 to 0.0
|
0.0 follicles
Interval 0.0 to 0.0
|
0.0 follicles
Interval 0.0 to 0.0
|
0.0 follicles
Interval 0.0 to 0.0
|
—
|
|
Ovarian Follicular Development: Number of Dominant Follicles With a Mean Diameter of ≥18 mm
Day 12
|
0.0 follicles
Interval 0.0 to 0.0
|
0.0 follicles
Interval 0.0 to 1.0
|
0.0 follicles
Interval 0.0 to 1.0
|
0.0 follicles
Interval 0.0 to 0.0
|
—
|
|
Ovarian Follicular Development: Number of Dominant Follicles With a Mean Diameter of ≥18 mm
Day 15
|
0.0 follicles
Interval 0.0 to 1.0
|
0.0 follicles
Interval 0.0 to 1.0
|
0.0 follicles
Interval 0.0 to 1.0
|
0.0 follicles
Interval 0.0 to 0.0
|
—
|
|
Ovarian Follicular Development: Number of Dominant Follicles With a Mean Diameter of ≥18 mm
Day 18
|
0.0 follicles
Interval 0.0 to 1.0
|
0.0 follicles
Interval 0.0 to 1.0
|
0.0 follicles
Interval 0.0 to 1.0
|
0.0 follicles
Interval 0.0 to 0.0
|
—
|
|
Ovarian Follicular Development: Number of Dominant Follicles With a Mean Diameter of ≥18 mm
Day 21
|
0.0 follicles
Interval 0.0 to 1.0
|
0.0 follicles
Interval 0.0 to 1.0
|
0.0 follicles
Interval 0.0 to 0.0
|
0.0 follicles
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: Treatment Days 19, 21, 23, 25, and 27Population: The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9).
Maximum of post-dose P4 levels collected on treatment Days 19 to 27 are presented.
Outcome measures
| Measure |
LutrePulse 10 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 10 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 15 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 20 µg/Pulse
n=10 Participants
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
|
Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled
n=10 Participants
Gonadorelin acetate SC 15 μg/pulse and SC 20 μg/pulse, administered via. OmniPod pump pooled
|
Placebo
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
|
|---|---|---|---|---|---|
|
Luteal Phase Support: Maximum P4 Levels
|
0.40 ng/mL
Interval 0.1 to 12.9
|
2.40 ng/mL
Interval 0.4 to 18.5
|
8.00 ng/mL
Interval 0.1 to 21.7
|
0.30 ng/mL
Interval 0.1 to 0.4
|
—
|
SECONDARY outcome
Timeframe: Median post-dose P4 values across Treatment Days 19, 21, 23, 25, and 27Population: The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9).
Mean of post-dose P4 levels collected on treatment Days 19 to 27 are presented.
Outcome measures
| Measure |
LutrePulse 10 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 10 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 15 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 20 µg/Pulse
n=10 Participants
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
|
Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled
n=10 Participants
Gonadorelin acetate SC 15 μg/pulse and SC 20 μg/pulse, administered via. OmniPod pump pooled
|
Placebo
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
|
|---|---|---|---|---|---|
|
Luteal Phase Support: Mean P4 Levels
|
0.313 ng/mL
Interval 0.1 to 8.06
|
1.440 ng/mL
Interval 0.26 to 8.5
|
3.920 ng/mL
Interval 0.1 to 14.8
|
0.233 ng/mL
Interval 0.1 to 0.4
|
—
|
SECONDARY outcome
Timeframe: Baseline (pre-dose), Treatment Day 1, Treatment Day 10Population: The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9).
FSH change from baseline in relation to the first dose (pulse) on Day 1 and Day 10
Outcome measures
| Measure |
LutrePulse 10 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 10 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 15 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 20 µg/Pulse
n=10 Participants
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
|
Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled
n=10 Participants
Gonadorelin acetate SC 15 μg/pulse and SC 20 μg/pulse, administered via. OmniPod pump pooled
|
Placebo
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
|
|---|---|---|---|---|---|
|
Change From Baseline in Follicle-stimulating Hormone (FSH)
FSH (Day 1)
|
1.30 IU/L
Interval 0.0 to 7.7
|
5.40 IU/L
Interval 0.0 to 9.9
|
2.70 IU/L
Interval 0.0 to 5.7
|
0.10 IU/L
Interval 0.0 to 0.6
|
—
|
|
Change From Baseline in Follicle-stimulating Hormone (FSH)
FSH (Day 10)
|
0.04 IU/L
Interval -0.8 to 0.8
|
-0.04 IU/L
Interval -0.3 to 0.4
|
0.04 IU/L
Interval -0.7 to 0.6
|
-0.01 IU/L
Interval -0.1 to 0.1
|
—
|
SECONDARY outcome
Timeframe: Baseline (pre-dose), Treatment Day 1, Treatment Day 10Population: The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9).
LH change from baseline in relation to first dose (pulse) on Day 1 and Day 10
Outcome measures
| Measure |
LutrePulse 10 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 10 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 15 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 20 µg/Pulse
n=10 Participants
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
|
Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled
n=10 Participants
Gonadorelin acetate SC 15 μg/pulse and SC 20 μg/pulse, administered via. OmniPod pump pooled
|
Placebo
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
|
|---|---|---|---|---|---|
|
Change From Baseline in LH
Day 1
|
1.85 IU/L
Interval 0.2 to 22.6
|
7.90 IU/L
Interval 0.4 to 23.6
|
5.15 IU/L
Interval 0.6 to 12.4
|
0.05 IU/L
Interval -0.2 to 0.3
|
—
|
|
Change From Baseline in LH
Day 10
|
0.00 IU/L
Interval -2.9 to 1.6
|
0.58 IU/L
Interval -1.7 to 1.9
|
0.03 IU/L
Interval -0.9 to 1.7
|
0.00 IU/L
Interval -1.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: Treatment Days 1 and Day 10Population: The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9).
Mean FSH and LH levels on Day 1 and Day 10.
Outcome measures
| Measure |
LutrePulse 10 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 10 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 15 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 20 µg/Pulse
n=10 Participants
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
|
Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled
n=10 Participants
Gonadorelin acetate SC 15 μg/pulse and SC 20 μg/pulse, administered via. OmniPod pump pooled
|
Placebo
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
|
|---|---|---|---|---|---|
|
Mean Serum FSH and LH Levels
FSH (Baseline)
|
1.59 IU/L
Standard Deviation 1.793
|
1.47 IU/L
Standard Deviation 1.112
|
2.48 IU/L
Standard Deviation 2.235
|
1.35 IU/L
Standard Deviation 1.520
|
—
|
|
Mean Serum FSH and LH Levels
FSH (Day 1)
|
3.64 IU/L
Standard Deviation 4.010
|
6.20 IU/L
Standard Deviation 3.929
|
5.38 IU/L
Standard Deviation 2.565
|
1.52 IU/L
Standard Deviation 1.673
|
—
|
|
Mean Serum FSH and LH Levels
FSH (Day 10)
|
4.00 IU/L
Standard Deviation 1.495
|
5.07 IU/L
Standard Deviation 2.530
|
5.24 IU/L
Standard Deviation 1.124
|
1.67 IU/L
Standard Deviation 1.796
|
—
|
|
Mean Serum FSH and LH Levels
LH (Baseline)
|
0.54 IU/L
Standard Deviation 0.669
|
0.27 IU/L
Standard Deviation 0.179
|
0.93 IU/L
Standard Deviation 0.954
|
0.73 IU/L
Standard Deviation 1.063
|
—
|
|
Mean Serum FSH and LH Levels
LH (Day 1)
|
6.27 IU/L
Standard Deviation 9.507
|
8.82 IU/L
Standard Deviation 7.348
|
6.12 IU/L
Standard Deviation 3.745
|
0.79 IU/L
Standard Deviation 1.026
|
—
|
|
Mean Serum FSH and LH Levels
LH (Day 10)
|
4.12 IU/L
Standard Deviation 3.931
|
4.69 IU/L
Standard Deviation 2.692
|
4.07 IU/L
Standard Deviation 2.335
|
0.82 IU/L
Standard Deviation 1.037
|
—
|
SECONDARY outcome
Timeframe: At treatment Day 1 and Day 10Population: The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9).
E2 serum levels on Day 1 and Day 10.
Outcome measures
| Measure |
LutrePulse 10 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 10 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 15 µg/Pulse
n=9 Participants
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 20 µg/Pulse
n=10 Participants
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
|
Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled
n=10 Participants
Gonadorelin acetate SC 15 μg/pulse and SC 20 μg/pulse, administered via. OmniPod pump pooled
|
Placebo
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
|
|---|---|---|---|---|---|
|
Estradiol (E2) Serum Levels
Day 1 (pre-dose)
|
36.50 pmol/L
Interval 36.5 to 169.0
|
88.00 pmol/L
Interval 36.5 to 147.0
|
81.00 pmol/L
Interval 36.5 to 92.0
|
122.50 pmol/L
Interval 36.5 to 198.0
|
—
|
|
Estradiol (E2) Serum Levels
Day 10 (pre-dose)
|
106.00 pmol/L
Interval 36.5 to 697.0
|
202.00 pmol/L
Interval 84.0 to 499.0
|
136.00 pmol/L
Interval 36.5 to 323.0
|
128.00 pmol/L
Interval 36.5 to 224.0
|
—
|
SECONDARY outcome
Timeframe: From treatment Day 1 to end-of-trial, approximately 10 weeksPopulation: The safety analysis set comprised all randomized subjects who received at least one pulsatile delivery of IMP. The number count is based on the actual treatment subjects received: one subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11)
An AE was defined as any untoward medical occurrence in a subject taking part in a clinical trial. Proportion of subjects with any AE (serious or non-serious) and intensity of AEs (classified as mild, moderate or severe) are presented.
Outcome measures
| Measure |
LutrePulse 10 µg/Pulse
n=10 Participants
Gonadorelin acetate SC 10 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 15 µg/Pulse
n=8 Participants
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 20 µg/Pulse
n=10 Participants
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
|
Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled
n=11 Participants
Gonadorelin acetate SC 15 μg/pulse and SC 20 μg/pulse, administered via. OmniPod pump pooled
|
Placebo
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
|
|---|---|---|---|---|---|
|
Type, Intensity, and Frequency of Adverse Events (AEs)
Any AE
|
5 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
—
|
|
Type, Intensity, and Frequency of Adverse Events (AEs)
Non-serious AE
|
5 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
—
|
|
Type, Intensity, and Frequency of Adverse Events (AEs)
Serious AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Type, Intensity, and Frequency of Adverse Events (AEs)
Intensity (Mild)
|
5 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Type, Intensity, and Frequency of Adverse Events (AEs)
Intensity (Moderate)
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Type, Intensity, and Frequency of Adverse Events (AEs)
Intensity (Severe)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: From treatment Day 1 to end-of-trial, approximately 10 weeksPopulation: The safety analysis set comprised all randomized subjects who received at least one pulsatile delivery of IMP. The number count is based on the actual treatment subjects received: one subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11)
Proportion of subjects with markedly abnormal changes in hematology, clinical chemistry, and urinalysis.
Outcome measures
| Measure |
LutrePulse 10 µg/Pulse
n=10 Participants
Gonadorelin acetate SC 10 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 15 µg/Pulse
n=8 Participants
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 20 µg/Pulse
n=10 Participants
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
|
Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled
n=11 Participants
Gonadorelin acetate SC 15 μg/pulse and SC 20 μg/pulse, administered via. OmniPod pump pooled
|
Placebo
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
|
|---|---|---|---|---|---|
|
Hematology, Clinical Chemistry, and Urinalysis
Hematology
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Hematology, Clinical Chemistry, and Urinalysis
Serum chemistry (Sodium, <=130 mmol/L)
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
—
|
|
Hematology, Clinical Chemistry, and Urinalysis
Urinalysis (Protein,mg/dL, -ve to +ve [post-dose])
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
—
|
|
Hematology, Clinical Chemistry, and Urinalysis
Urinalysis (Specific Gravity <=1.005)
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: From treatment Day 1 to end-of-trial, approximately 10 weeksPopulation: The safety analysis set comprised all randomized subjects who received at least one pulsatile delivery of IMP. The number count is based on the actual treatment subjects received: one subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11)
Proportion of subjects reporting OHSS classified as mild, moderate, or severe.
Outcome measures
| Measure |
LutrePulse 10 µg/Pulse
n=10 Participants
Gonadorelin acetate SC 10 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 15 µg/Pulse
n=8 Participants
Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 20 µg/Pulse
n=10 Participants
Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
|
Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled
n=11 Participants
Gonadorelin acetate SC 15 μg/pulse and SC 20 μg/pulse, administered via. OmniPod pump pooled
|
Placebo
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
|
|---|---|---|---|---|---|
|
Frequency and Severity of Ovarian Hyperstimulation Syndrome (OHSS)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
Adverse Events
LutrePulse 10 µg/Pulse
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
LutrePulse 15 µg/Pulse
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LutrePulse 20 µg/Pulse
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LutrePulse 10 µg/Pulse
n=10 participants at risk
Gonadorelin acetate SC 10 µg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 15 µg/Pulse
n=8 participants at risk
Gonadorelin acetate SC 15 µg/pulse as a fixed dose, administered via. OmniPod pump
|
LutrePulse 20 µg/Pulse
n=10 participants at risk
Gonadorelin acetate SC 20 µg/pulse as a fixed dose, administered via. OmniPod pump
|
Placebo
n=11 participants at risk
Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
10.0%
1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/11 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Gastrointestinal disorders
Abdominal distesion
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
10.0%
1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
9.1%
1/11 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
10.0%
1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/11 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/11 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
10.0%
1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/11 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
12.5%
1/8 • Number of events 2 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
10.0%
1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/11 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
10.0%
1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/11 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
General disorders
Administration site pain
|
10.0%
1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/11 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
General disorders
Application site pain
|
10.0%
1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
9.1%
1/11 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
General disorders
Application site pruritus
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
9.1%
1/11 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
General disorders
Fatigue
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
9.1%
1/11 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
General disorders
Injection site pain
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
9.1%
1/11 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
10.0%
1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
9.1%
1/11 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/11 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/11 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
10.0%
1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/11 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
9.1%
1/11 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/11 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/11 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Nervous system disorders
Migraine
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
9.1%
1/11 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
10.0%
1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/11 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Reproductive system and breast disorders
Adnexa uteri pain
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/11 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Reproductive system and breast disorders
Breast discomfort
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
10.0%
1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/11 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
25.0%
2/8 • Number of events 2 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
20.0%
2/10 • Number of events 2 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/11 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
10.0%
1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/11 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
9.1%
1/11 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
9.1%
1/11 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
10.0%
1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/11 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/11 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
10.0%
1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/11 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
|
Vascular disorders
Hot flushes
|
0.00%
0/10 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
12.5%
1/8 • Number of events 2 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
20.0%
2/10 • Number of events 2 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
0.00%
0/11 • Treatment-emergent AEs (TEAEs) occurred after the start of IMP administration and within 5 days after the last dose, or a pre-treatment AE or pre-existing medical conditioning the worsened in intensity after the start of IMP and within 5 days after the last dose
TEAEs were defined as AEs that occurred after the start of IMP administration and within 5 days after the last dose. All subjects who received at least one pulsatile injection delivery of IMP were included in safety analysis set and were analyzed according to the actual treatment received. One subject randomized to LutrePulse 15 µg/Pulse had received placebo and was moved to the placebo group in the safety analysis set (LutrePulse 15 µg/Pulse: n=8, Placebo: n=11).
|
Additional Information
Clinical Development Support
Ferring Pharmaceuticals
Phone: +1 833-548-1402
Email: [email protected]
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