Trial Outcomes & Findings for Study to Compare the Oestradiol Suppression, Clinical Efficacy and Safety of Two Formulations of Triptorelin (Triptorelin Pamoate PR 3-month and Triptorelin Acetate PR 1-month) in Chinese Subjects With Endometriosis (NCT NCT03232281)
NCT ID: NCT03232281
Last Updated: 2021-10-14
Results Overview
Castration was defined as serum oestradiol (E2) ≤184 picomoles/litre (pmol/L) or 50 picograms/millilitre (pg/mL). The primary endpoint was evaluated based on centralised blinded bioanalysis of serum samples for E2. The percentage of subjects castrated and the 95% asymptotic confidence intervals (CIs), calculated from binomial distribution, are presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
Week 12
Results posted on
2021-10-14
Participant Flow
Female subjects aged from 18 to 45 years were recruited to this Phase 3 randomised, open-label study at 24 study centres in China between 28 July 2017 and 16 November 2019.
Subjects who met the inclusion criteria and none of the exclusion criteria were randomised in a 1:1 ratio, stratified according to endometriotic surgical history and the severity of endometriosis-associated pelvic pain.
Participant milestones
| Measure |
Triptorelin Pamoate PR 3-month
Subjects received 15 milligrams (mg) triptorelin pamoate per injection, administered as an intramuscular (IM) injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
|
Triptorelin Acetate PR 1-month
Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
150
|
|
Overall Study
Received Treatment
|
149
|
150
|
|
Overall Study
Completed Week 12
|
143
|
148
|
|
Overall Study
Completed Week 24
|
143
|
144
|
|
Overall Study
COMPLETED
|
143
|
144
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
Triptorelin Pamoate PR 3-month
Subjects received 15 milligrams (mg) triptorelin pamoate per injection, administered as an intramuscular (IM) injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
|
Triptorelin Acetate PR 1-month
Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
|
Overall Study
Protocol Deviation
|
1
|
1
|
Baseline Characteristics
Study to Compare the Oestradiol Suppression, Clinical Efficacy and Safety of Two Formulations of Triptorelin (Triptorelin Pamoate PR 3-month and Triptorelin Acetate PR 1-month) in Chinese Subjects With Endometriosis
Baseline characteristics by cohort
| Measure |
Triptorelin Pamoate PR 3-month
n=150 Participants
Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
|
Triptorelin Acetate PR 1-month
n=150 Participants
Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
32.6 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
32.5 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
150 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
150 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
150 participants
n=5 Participants
|
150 participants
n=7 Participants
|
300 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: The per protocol set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter, and without major protocol violations/deviations affecting the primary efficacy endpoint.
Castration was defined as serum oestradiol (E2) ≤184 picomoles/litre (pmol/L) or 50 picograms/millilitre (pg/mL). The primary endpoint was evaluated based on centralised blinded bioanalysis of serum samples for E2. The percentage of subjects castrated and the 95% asymptotic confidence intervals (CIs), calculated from binomial distribution, are presented.
Outcome measures
| Measure |
Triptorelin Pamoate PR 3-month
n=142 Participants
Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
|
Triptorelin Acetate PR 1-month
n=146 Participants
Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
|
|---|---|---|
|
Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Week 12
|
98.6 percentage of subjects
Interval 96.65 to 100.0
|
99.3 percentage of subjects
Interval 97.98 to 100.0
|
SECONDARY outcome
Timeframe: Weeks 4 and 8Population: The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter.
The percentages of subjects who were castrated at Weeks 4 and 8 where castration was defined as serum E2 ≤184 pmol/L or 50 pg/mL are presented. The 95% asymptotic CIs were calculated from the binomial distribution.
Outcome measures
| Measure |
Triptorelin Pamoate PR 3-month
n=147 Participants
Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
|
Triptorelin Acetate PR 1-month
n=150 Participants
Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
|
|---|---|---|
|
Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8
Week 4
|
98.0 percentage of subjects
Interval 95.67 to 100.0
|
99.3 percentage of subjects
Interval 98.03 to 100.0
|
|
Percentage of Subjects Castrated (E2 ≤184 Pmol/L or 50 pg/mL) at Weeks 4 and 8
Week 8
|
97.3 percentage of subjects
Interval 94.65 to 99.91
|
100.0 percentage of subjects
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12Population: The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter.
The percentages of subjects who were castrated at Weeks 4, 8 and 12 where castration was defined as serum E2 ≤110 pmol/L or 30 pg/mL are presented. The 95% asymptotic CIs were calculated from the binomial distribution.
Outcome measures
| Measure |
Triptorelin Pamoate PR 3-month
n=147 Participants
Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
|
Triptorelin Acetate PR 1-month
n=150 Participants
Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
|
|---|---|---|
|
Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12
Week 12
|
95.9 percentage of subjects
Interval 92.72 to 99.12
|
98.7 percentage of subjects
Interval 96.83 to 100.0
|
|
Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12
Week 4
|
98.0 percentage of subjects
Interval 95.67 to 100.0
|
99.3 percentage of subjects
Interval 98.03 to 100.0
|
|
Percentage of Subjects Castrated (E2 ≤110 Pmol/L or 30 pg/mL) at Weeks 4, 8 and 12
Week 8
|
95.2 percentage of subjects
Interval 91.8 to 98.68
|
99.3 percentage of subjects
Interval 98.03 to 100.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 8 and 12Population: The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter.
Endometriosis-associated pelvic pain was assessed using a 100 millimetres (mm) visual analogue scale (VAS) where subjects indicated the subjective level of their most severe endometriosis pain over the last 4 weeks by making a single vertical mark on the line ranging from 'absence of pain' (0 mm) to 'unbearable pain' (100 mm). Lower scores indicated a better outcome. Baseline was defined as the last available assessment prior to the first dose of study medication. The least squares (LS) mean change from baseline at each timepoint as measured by the VAS is presented.
Outcome measures
| Measure |
Triptorelin Pamoate PR 3-month
n=147 Participants
Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
|
Triptorelin Acetate PR 1-month
n=150 Participants
Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
|
|---|---|---|
|
Change From Baseline in Endometriosis-associated Pelvic Pain at Weeks 4, 8 and 12
Week 8
|
-28.5 mm
Interval -31.1 to -25.9
|
-27.8 mm
Interval -30.3 to -25.2
|
|
Change From Baseline in Endometriosis-associated Pelvic Pain at Weeks 4, 8 and 12
Week 4
|
-24.4 mm
Interval -27.2 to -21.6
|
-24.4 mm
Interval -27.1 to -21.6
|
|
Change From Baseline in Endometriosis-associated Pelvic Pain at Weeks 4, 8 and 12
Week 12
|
-28.1 mm
Interval -30.6 to -25.7
|
-28.4 mm
Interval -30.8 to -26.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 8 and 12Population: The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter.
The mean serum E2 concentrations at baseline and Weeks 4, 8 and 12 are presented.
Outcome measures
| Measure |
Triptorelin Pamoate PR 3-month
n=147 Participants
Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
|
Triptorelin Acetate PR 1-month
n=150 Participants
Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
|
|---|---|---|
|
Mean E2 Concentration at Weeks Baseline and 4, 8 and 12
Baseline
|
192.302 pmol/L
Standard Deviation 258.209
|
218.893 pmol/L
Standard Deviation 296.825
|
|
Mean E2 Concentration at Weeks Baseline and 4, 8 and 12
Week 4
|
25.347 pmol/L
Standard Deviation 46.253
|
18.959 pmol/L
Standard Deviation 3.944
|
|
Mean E2 Concentration at Weeks Baseline and 4, 8 and 12
Week 8
|
47.175 pmol/L
Standard Deviation 156.521
|
21.863 pmol/L
Standard Deviation 12.550
|
|
Mean E2 Concentration at Weeks Baseline and 4, 8 and 12
Week 12
|
36.600 pmol/L
Standard Deviation 76.882
|
26.695 pmol/L
Standard Deviation 31.174
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 8 and 12Population: The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter.
The mean FSH concentrations at baseline and Weeks 4, 8 and 12 are presented.
Outcome measures
| Measure |
Triptorelin Pamoate PR 3-month
n=147 Participants
Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
|
Triptorelin Acetate PR 1-month
n=150 Participants
Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
|
|---|---|---|
|
Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12
Baseline
|
6.099 International Units/L (IU/L)
Standard Deviation 3.929
|
6.258 International Units/L (IU/L)
Standard Deviation 4.520
|
|
Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12
Week 4
|
1.762 International Units/L (IU/L)
Standard Deviation 1.373
|
1.699 International Units/L (IU/L)
Standard Deviation 1.049
|
|
Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12
Week 8
|
2.891 International Units/L (IU/L)
Standard Deviation 1.163
|
2.766 International Units/L (IU/L)
Standard Deviation 1.329
|
|
Mean Follicle Stimulating Hormone (FSH) Concentration at Baseline and Weeks 4, 8 and 12
Week 12
|
3.344 International Units/L (IU/L)
Standard Deviation 1.347
|
3.325 International Units/L (IU/L)
Standard Deviation 1.414
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8 and 12Population: The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter.
The mean LH concentrations at baseline and Weeks 4, 8 and 12 are presented.
Outcome measures
| Measure |
Triptorelin Pamoate PR 3-month
n=147 Participants
Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
|
Triptorelin Acetate PR 1-month
n=150 Participants
Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
|
|---|---|---|
|
Mean Luteinising Hormone (LH) Concentration at Baseline and Weeks 4, 8 and 12
Baseline
|
3.376 IU/L
Standard Deviation 1.902
|
3.487 IU/L
Standard Deviation 1.858
|
|
Mean Luteinising Hormone (LH) Concentration at Baseline and Weeks 4, 8 and 12
Week 4
|
0.660 IU/L
Standard Deviation 1.771
|
0.500 IU/L
Standard Deviation 0.173
|
|
Mean Luteinising Hormone (LH) Concentration at Baseline and Weeks 4, 8 and 12
Week 8
|
0.444 IU/L
Standard Deviation 1.928
|
0.255 IU/L
Standard Deviation 0.122
|
|
Mean Luteinising Hormone (LH) Concentration at Baseline and Weeks 4, 8 and 12
Week 12
|
0.324 IU/L
Standard Deviation 0.555
|
0.251 IU/L
Standard Deviation 0.239
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Week 40 (end of study visit)Population: The full analysis set included all randomised subjects who received at least one dose of study medication with at least one baseline and at least one post-baseline assessment of the primary efficacy parameter.
Time to menses recovery was defined as the time (in days) between the date of the last dose of study medication and the date of the first day the subject observed menstrual bleeding of the next menstrual period. Menses recovery status was assessed at all study visits from Day 1 to the end of study visit. The median time to menses recovery was analysed using the Kaplan-Meier method.
Outcome measures
| Measure |
Triptorelin Pamoate PR 3-month
n=147 Participants
Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
|
Triptorelin Acetate PR 1-month
n=150 Participants
Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
|
|---|---|---|
|
Median Time to Menses Recovery
|
179.0 days
Interval 172.0 to 182.0
|
85.0 days
Interval 82.0 to 87.0
|
Adverse Events
Triptorelin Pamoate PR 3-month
Serious events: 2 serious events
Other events: 132 other events
Deaths: 0 deaths
Triptorelin Acetate PR 1-month
Serious events: 1 serious events
Other events: 135 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Triptorelin Pamoate PR 3-month
n=149 participants at risk
Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
|
Triptorelin Acetate PR 1-month
n=150 participants at risk
Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
|
|---|---|---|
|
Infections and infestations
Pyelonephritis acute
|
0.67%
1/149 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
0.00%
0/150 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Sepsis
|
0.67%
1/149 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
0.00%
0/150 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Cardiac disorders
Arrhythmia
|
0.67%
1/149 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
0.00%
0/150 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Cardiac disorders
Sinus bradycardia
|
0.67%
1/149 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
0.00%
0/150 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/149 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
0.67%
1/150 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
Other adverse events
| Measure |
Triptorelin Pamoate PR 3-month
n=149 participants at risk
Subjects received 15 mg triptorelin pamoate per injection, administered as an IM injection once every 12 weeks (a total of 2 injections, at baseline and Week 12).
|
Triptorelin Acetate PR 1-month
n=150 participants at risk
Subjects received 3.75 mg triptorelin acetate per injection, administered as an IM injection once every 4 weeks (a total of 6 injections, at baseline and Weeks 4, 8, 12, 16 and 20).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.7%
4/149 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
8.7%
13/150 • Number of events 19 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.0%
6/149 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
5.3%
8/150 • Number of events 10 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
8/149 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
2.7%
4/150 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
4.0%
6/149 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
5.3%
8/150 • Number of events 9 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
10.7%
16/149 • Number of events 19 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
16.0%
24/150 • Number of events 30 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
24.8%
37/149 • Number of events 46 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
18.0%
27/150 • Number of events 34 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Infections and infestations
Vaginal infection
|
5.4%
8/149 • Number of events 9 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
4.7%
7/150 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Investigations
Protein urine present
|
6.0%
9/149 • Number of events 9 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
5.3%
8/150 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.1%
12/149 • Number of events 19 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
8.7%
13/150 • Number of events 15 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.0%
9/149 • Number of events 11 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
6.0%
9/150 • Number of events 10 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.3%
2/149 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
6.0%
9/150 • Number of events 13 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
4.0%
6/149 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
6.0%
9/150 • Number of events 11 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
6.7%
10/149 • Number of events 11 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
6.0%
9/150 • Number of events 11 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
9.4%
14/149 • Number of events 14 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
5.3%
8/150 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Menorrhagia
|
7.4%
11/149 • Number of events 13 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
4.0%
6/150 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
44.3%
66/149 • Number of events 79 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
45.3%
68/150 • Number of events 82 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.7%
4/149 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
5.3%
8/150 • Number of events 9 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.7%
10/149 • Number of events 10 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
8.0%
12/150 • Number of events 12 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
12.8%
19/149 • Number of events 20 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
8.7%
13/150 • Number of events 13 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
|
Vascular disorders
Hot flush
|
57.7%
86/149 • Number of events 90 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
59.3%
89/150 • Number of events 91 • Treatment-emergent adverse events (TEAEs) were monitored from Day 1 up to Week 28 (approximately 7 months).
A TEAE was defined as any adverse event that occurred or worsened on or after the first dose, through 112 days (16 weeks) after last injection of triptorelin pamoate PR 3-month or through 56 days (8 weeks) after last injection for triptorelin acetate PR 1-month. TEAEs are presented for the safety set which included all subjects who received at least one dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place