Trial Outcomes & Findings for Triptorelin for Ovary Protection in Childhood Onset Lupus (NCT NCT00124514)
NCT ID: NCT00124514
Last Updated: 2021-01-05
Results Overview
Dose escalation was initiated If COS was not maintained with the 1st dose of study drug. Subsequent doses were increased by 25% or at least 20μg/kg dose. This procedure of dose increases by 25% or at least 20μg/kg dose was repeated until COS was maintained. Absolute max dose 7.8mg. Triptorelin (T1-T4) groups were pooled for analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
baseline to week 24
Results posted on
2021-01-05
Participant Flow
130 patients were screened for the study and 31 were randomized to one of 5 arms to start. The arms determined the starting dose of Triptorelin. All arms participated in dose escalation until the subjects reached and maintained COS. 2 subjects withdrew prior to start of study procedures.
Participant milestones
| Measure |
Placebo
Normal Saline
|
Triptorelin T1
Triptorelin Pamoate 25 μg/kg body weight starting dose
Dose escalation initiated if COS was not maintained with the 1st dose of study drug. The subsequently injected 2nd dose was increased by 25% or at least 20 μg/kg dose. This procedure of dose increases repeated until COS was maintained.
|
Triptorelin T2
Triptorelin Pamoate 50 μg/kg body weight starting dose
Dose escalation initiated if COS was not maintained with the 1st dose of study drug. The subsequently injected 2nd dose was increased by 25% or at least 20 μg/kg dose. This procedure of dose increases repeated until COS was maintained.
|
Triptorelin T3
Triptorelin Pamoate 75 μg/kg body weight starting dose
Dose escalation initiated if COS was not maintained with the 1st dose of study drug. The subsequently injected 2nd dose was increased by 25% or at least 20 μg/kg dose. This procedure of dose increases repeated until COS was maintained.
|
Triptorelin T4
Triptorelin Pamoate 100 μg/kg body weight starting dose
Dose escalation initiated if COS was not maintained with the 1st dose of study drug. The subsequently injected 2nd dose was increased by 25% or at least 20 μg/kg dose. This procedure of dose increases repeated until COS was maintained.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
9
|
8
|
6
|
2
|
|
Overall Study
COMPLETED
|
2
|
7
|
7
|
5
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
1
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Triptorelin for Ovary Protection in Childhood Onset Lupus
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
Normal Saline
placebo: placebo 0.9% normal saline IM injection
|
Triptorelin T1
n=9 Participants
Triptorelin Pamoate 25 μg/kg body weight
|
Triptorelin T2
n=8 Participants
Triptorelin Pamoate 50 μg/kg body weight
|
Triptorelin T3
n=6 Participants
Triptorelin Pamoate 75 μg/kg body weight
|
Triptorelin T4
n=2 Participants
Triptorelin Pamoate 100 μg/kg body weight
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
17.9 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
15.9 years
STANDARD_DEVIATION 2.6 • n=7 Participants
|
16.5 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
13.0 years
STANDARD_DEVIATION 2.1 • n=4 Participants
|
12.50 years
STANDARD_DEVIATION 0 • n=21 Participants
|
15.4 years
STANDARD_DEVIATION 4.1 • n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
31 Participants
n=8 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
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
16 Participants
n=8 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
|
0 Participants
n=8 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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: baseline to week 24Dose escalation was initiated If COS was not maintained with the 1st dose of study drug. Subsequent doses were increased by 25% or at least 20μg/kg dose. This procedure of dose increases by 25% or at least 20μg/kg dose was repeated until COS was maintained. Absolute max dose 7.8mg. Triptorelin (T1-T4) groups were pooled for analysis.
Outcome measures
| Measure |
Placebo
n=4 Participants
Normal Saline
placebo: placebo 0.9% normal saline IM injection
|
Triptorelin (T1-T4)
n=21 Participants
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|---|---|---|
|
Dose of Triptorelin for Ovarian Suppression
|
NA μg/kg
Ovarian suppression not reached in placebo group
|
120 μg/kg
|
SECONDARY outcome
Timeframe: baseline to week 24Time to ovarian suppression, based on suppressed LH levels, after the initial dose of triptorelin. Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
Outcome measures
| Measure |
Placebo
n=4 Participants
Normal Saline
placebo: placebo 0.9% normal saline IM injection
|
Triptorelin (T1-T4)
n=21 Participants
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|---|---|---|
|
Length of Time of Triptorelin Treatment to Achieve Ovarian Suppression
|
NA days
Ovarian suppression not reached in placebo group
|
18 days
Interval 15.0 to 25.0
|
Adverse Events
Placebo Group
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Triptorelin
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Group
n=6 participants at risk
Normal Saline
placebo: placebo 0.9% normal saline IM injection
|
Triptorelin
n=25 participants at risk
Triptorelin Pamoate
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|---|---|---|
|
General disorders
Oedema peripheral
|
0.00%
0/6
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
4.0%
1/25 • Number of events 2
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
16.7%
1/6 • Number of events 1
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
0.00%
0/25
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
4.0%
1/25 • Number of events 1
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
Nervous system disorders
Neuropsychiatric lupus
|
0.00%
0/6
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
4.0%
1/25 • Number of events 1
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
Infections and infestations
Infection
|
16.7%
1/6 • Number of events 1
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
4.0%
1/25 • Number of events 1
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
0.00%
0/25
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
Infections and infestations
Herpes zoster
|
16.7%
1/6 • Number of events 1
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
8.0%
2/25 • Number of events 2
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
4.0%
1/25 • Number of events 1
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
Vascular disorders
Diffuse vasculitis
|
0.00%
0/6
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
4.0%
1/25 • Number of events 1
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.00%
0/6
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
4.0%
1/25 • Number of events 1
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
4.0%
1/25 • Number of events 1
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
General disorders
Chest pain
|
0.00%
0/6
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
4.0%
1/25 • Number of events 1
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
Other adverse events
| Measure |
Placebo Group
n=6 participants at risk
Normal Saline
placebo: placebo 0.9% normal saline IM injection
|
Triptorelin
n=25 participants at risk
Triptorelin Pamoate
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
8.0%
2/25 • Number of events 2
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
8.0%
2/25 • Number of events 2
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
12.0%
3/25 • Number of events 4
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
4.0%
1/25 • Number of events 1
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
12.0%
3/25 • Number of events 4
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
Vascular disorders
Hot flush
|
16.7%
1/6 • Number of events 1
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
20.0%
5/25 • Number of events 5
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
16.0%
4/25 • Number of events 4
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
12.0%
3/25 • Number of events 4
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
8.0%
2/25 • Number of events 2
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
8.0%
2/25 • Number of events 2
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
General disorders
Oedema
|
0.00%
0/6
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
8.0%
2/25 • Number of events 2
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • Number of events 1
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
8.0%
2/25 • Number of events 2
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
Psychiatric disorders
Suicidal ideation
|
16.7%
1/6 • Number of events 1
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
0.00%
0/25
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
8.0%
2/25 • Number of events 2
Due to the dose escalation during the study, Triptorelin (T1-T4) groups were pooled for analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place