Trial Outcomes & Findings for Histrelin Subcutaneous Implant in Children With Central Precocious Puberty (NCT NCT00779103)
NCT ID: NCT00779103
Last Updated: 2021-01-08
Results Overview
The suppression of gonadotropins (luteinizing hormone and follicle stimulating hormone) and gonadal sex steroids (estrogen in girls and testosterone in boys, respectively) on treatment.(LH suppression is defined as a peak LH \< 4 mIU/mL following stimulation with the GnRH analog).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
36 participants
Primary outcome timeframe
Baseline - 6 Months Post Last Implant
Results posted on
2021-01-08
Participant Flow
Participant milestones
| Measure |
Overall - Histrelin Subcutaneous Implant (50 mg)
Subcutaneous implant designed to deliver histrelin continously for 12 months.
Histrelin Subcutaneous Implant: histrelin subcutaneous 50 mg implant
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
Second & Third Implant
|
31
|
|
Overall Study
Fourth Implant
|
13
|
|
Overall Study
No Treatment
|
9
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Histrelin Subcutaneous Implant in Children With Central Precocious Puberty
Baseline characteristics by cohort
| Measure |
Histrelin Subcutaneous Implant (50 mg)
n=31 Participants
Subcutaneous implant designed to deliver histrelin continously for 12 months.
Histrelin Subcutaneous Implant: histrelin subcutaneous 50 mg implant
Extension Safety Population (Second \& Third Implant)
|
|---|---|
|
Age, Continuous
|
7.7 years
STANDARD_DEVIATION 1.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
|
Height
|
134.18 cm
STANDARD_DEVIATION 12.947 • n=5 Participants
|
|
Weight
|
38.12 kg
STANDARD_DEVIATION 11.835 • n=5 Participants
|
|
Body Mass Index (BMI)
|
20.66 kg/m^2
STANDARD_DEVIATION 3.541 • n=5 Participants
|
|
Pretreatment with Prior GnRH Therapy
Pretreated
|
13 Participants
n=5 Participants
|
|
Pretreatment with Prior GnRH Therapy
Naïve
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline - 6 Months Post Last ImplantPopulation: Extension Safety Population
The suppression of gonadotropins (luteinizing hormone and follicle stimulating hormone) and gonadal sex steroids (estrogen in girls and testosterone in boys, respectively) on treatment.(LH suppression is defined as a peak LH \< 4 mIU/mL following stimulation with the GnRH analog).
Outcome measures
| Measure |
Observed Value
n=31 Participants
|
Change From Baseline
n=31 Participants
|
|---|---|---|
|
Luteinizing Hormone (LH)
Month 66, Visit 18
|
0.18 MIU/ML
Standard Deviation 0.020
|
0.07 MIU/ML
Standard Deviation 0.100
|
|
Luteinizing Hormone (LH)
Month 72, Visit 19
|
0.36 MIU/ML
Standard Deviation 0.357
|
0.26 MIU/ML
Standard Deviation 0.237
|
|
Luteinizing Hormone (LH)
Baseline
|
0.88 MIU/ML
Standard Deviation 1.244
|
—
|
|
Luteinizing Hormone (LH)
Day 1, Visit 1
|
0.53 MIU/ML
|
0.07 MIU/ML
|
|
Luteinizing Hormone (LH)
Month 1, Visit 2
|
0.50 MIU/ML
Standard Deviation 0.302
|
-0.37 MIU/ML
Standard Deviation 1.111
|
|
Luteinizing Hormone (LH)
Month 3, Visit 3
|
0.39 MIU/ML
Standard Deviation 0.247
|
-0.50 MIU/ML
Standard Deviation 1.173
|
|
Luteinizing Hormone (LH)
Month 6, Visit 4
|
0.37 MIU/ML
Standard Deviation 0.225
|
-0.53 MIU/ML
Standard Deviation 1.227
|
|
Luteinizing Hormone (LH)
Month 9, Visit 5
|
0.38 MIU/ML
Standard Deviation 0.266
|
-0.51 MIU/ML
Standard Deviation 1.170
|
|
Luteinizing Hormone (LH)
Month 12, Visit 6
|
0.38 MIU/ML
Standard Deviation 0.247
|
-0.50 MIU/ML
Standard Deviation 1.108
|
|
Luteinizing Hormone (LH)
Month 13, Visit 7
|
0.35 MIU/ML
Standard Deviation 0.216
|
-0.58 MIU/ML
Standard Deviation 1.217
|
|
Luteinizing Hormone (LH)
Month 18, Visit 9
|
0.24 MIU/ML
Standard Deviation 0.118
|
-0.68 MIU/ML
Standard Deviation 1.233
|
|
Luteinizing Hormone (LH)
Month 24, Visit 11
|
0.22 MIU/ML
Standard Deviation 0.124
|
-0.66 MIU/ML
Standard Deviation 1.228
|
|
Luteinizing Hormone (LH)
Month 36, Visit 13
|
0.19 MIU/ML
Standard Deviation 0.126
|
-0.42 MIU/ML
Standard Deviation 0.734
|
|
Luteinizing Hormone (LH)
Month 42, Visit 14
|
0.14 MIU/ML
Standard Deviation 0.119
|
-0.53 MIU/ML
Standard Deviation 0.842
|
|
Luteinizing Hormone (LH)
Month 48, Visit 15
|
0.25 MIU/ML
Standard Deviation 0.232
|
-0.36 MIU/ML
Standard Deviation 0.871
|
|
Luteinizing Hormone (LH)
Month 54, Visit 16
|
0.24 MIU/ML
Standard Deviation 0.272
|
-0.47 MIU/ML
Standard Deviation 1.402
|
|
Luteinizing Hormone (LH)
Month 60, Visit 17
|
0.27 MIU/ML
Standard Deviation 0.336
|
-0.24 MIU/ML
Standard Deviation 0.937
|
|
Luteinizing Hormone (LH)
1 Month Post Last Implant
|
0.81 MIU/ML
Standard Deviation 0.952
|
0.53 MIU/ML
Standard Deviation 0.958
|
|
Luteinizing Hormone (LH)
6 Month Post Last Implant
|
3.66 MIU/ML
Standard Deviation 2.463
|
3.38 MIU/ML
Standard Deviation 2.410
|
SECONDARY outcome
Timeframe: Baseline - 6 Month Post Last ImplantPopulation: Extension Safety Population
The suppression of gonadotropins (luteinizing hormone and follicle stimulating hormone) and gonadal sex steroids (estrogen in girls and testosterone in boys, respectively) on treatment.(LH suppression is defined as a peak LH \< 4 mIU/mL following stimulation with the GnRH analog).
Outcome measures
| Measure |
Observed Value
n=31 Participants
|
Change From Baseline
n=31 Participants
|
|---|---|---|
|
Follicle Stimulating Hormone (FSH)
Month 72, Visit 19
|
1.24 MIU/ML
Standard Deviation 0.369
|
-0.41 MIU/ML
Standard Deviation 1.257
|
|
Follicle Stimulating Hormone (FSH)
6 Month Post Last Implant
|
4.96 MIU/ML
Standard Deviation 1.411
|
3.46 MIU/ML
Standard Deviation 1.040
|
|
Follicle Stimulating Hormone (FSH)
Baseline
|
2.26 MIU/ML
Standard Deviation 1.656
|
—
|
|
Follicle Stimulating Hormone (FSH)
Day 1, Visit 1
|
1.60 MIU/ML
|
-0.20 MIU/ML
|
|
Follicle Stimulating Hormone (FSH)
Month 1, Visit 2
|
1.08 MIU/ML
Standard Deviation 0.611
|
-1.18 MIU/ML
Standard Deviation 1.566
|
|
Follicle Stimulating Hormone (FSH)
Month 3, Visit 3
|
1.36 MIU/ML
Standard Deviation 0.814
|
-0.90 MIU/ML
Standard Deviation 1.464
|
|
Follicle Stimulating Hormone (FSH)
Month 6, Visit 4
|
1.43 MIU/ML
Standard Deviation 0.787
|
-0.86 MIU/ML
Standard Deviation 1.674
|
|
Follicle Stimulating Hormone (FSH)
Month 9, Visit 5
|
1.77 MIU/ML
Standard Deviation 0.939
|
-0.52 MIU/ML
Standard Deviation 1.776
|
|
Follicle Stimulating Hormone (FSH)
Month 12, Visit 6
|
2.16 MIU/ML
Standard Deviation 1.712
|
-0.10 MIU/ML
Standard Deviation 1.868
|
|
Follicle Stimulating Hormone (FSH)
Month 13, Visit 7
|
1.68 MIU/ML
Standard Deviation 1.048
|
-0.65 MIU/ML
Standard Deviation 1.394
|
|
Follicle Stimulating Hormone (FSH)
Month 18, Visit 9
|
1.81 MIU/ML
Standard Deviation 1.142
|
-0.50 MIU/ML
Standard Deviation 1.668
|
|
Follicle Stimulating Hormone (FSH)
Month 24, Visit 11
|
1.89 MIU/ML
Standard Deviation 0.855
|
-0.37 MIU/ML
Standard Deviation 1.486
|
|
Follicle Stimulating Hormone (FSH)
Month 36, Visit 13
|
1.91 MIU/ML
Standard Deviation 1.146
|
-0.01 MIU/ML
Standard Deviation 1.027
|
|
Follicle Stimulating Hormone (FSH)
Month 42, Visit 14
|
1.63 MIU/ML
Standard Deviation 1.119
|
-0.62 MIU/ML
Standard Deviation 1.457
|
|
Follicle Stimulating Hormone (FSH)
Month 48, Visit 15
|
1.55 MIU/ML
Standard Deviation 1.199
|
-0.48 MIU/ML
Standard Deviation 1.619
|
|
Follicle Stimulating Hormone (FSH)
Month 54, Visit 16
|
1.43 MIU/ML
Standard Deviation 0.752
|
-0.73 MIU/ML
Standard Deviation 2.288
|
|
Follicle Stimulating Hormone (FSH)
Month 60, Visit 17
|
1.50 MIU/ML
Standard Deviation 0.741
|
-0.57 MIU/ML
Standard Deviation 1.573
|
|
Follicle Stimulating Hormone (FSH)
Month 66, Visit 18
|
0.76 MIU/ML
Standard Deviation 0.049
|
-0.89 MIU/ML
Standard Deviation 1.578
|
|
Follicle Stimulating Hormone (FSH)
1 Month Post Last Implant
|
3.04 MIU/ML
Standard Deviation 2.125
|
1.80 MIU/ML
Standard Deviation 1.792
|
SECONDARY outcome
Timeframe: Baseline - 12 Months Post Last ImplantPopulation: Extension Safety Population
Long-term treatment with histrelin acetate suppresses the LH response to GnRH causing LH levels to decrease to prepubertal levels within 1 month of treatment. As a result, serum concentrations of sex steroids (estrogen or testosterone) also decrease. Testosterone suppression is defined as serum testosterone \< 30.0 ng/dL (0.8 nmol/L) in boys following the induction of suppression. One black female participant age 8.9 years old had a testosterone value of 11ng/dL at visit 4 (month 6).
Outcome measures
| Measure |
Observed Value
n=3 Participants
|
Change From Baseline
n=2 Participants
|
|---|---|---|
|
Testosterone
Baseline
|
10.95 NG/DL
Standard Deviation 1.485
|
—
|
|
Testosterone
Month 1, Visit 2
|
6.50 NG/DL
Standard Deviation 2.687
|
-4.45 NG/DL
Standard Deviation 1.202
|
|
Testosterone
Month 3, Visit 3
|
8.25 NG/DL
Standard Deviation 2.475
|
-2.70 NG/DL
Standard Deviation 0.990
|
|
Testosterone
Month 6, Visit 4
|
12.67 NG/DL
Standard Deviation 2.082
|
2.55 NG/DL
Standard Deviation 3.606
|
|
Testosterone
Month 9, Visit 5
|
8.15 NG/DL
Standard Deviation 2.616
|
-2.80 NG/DL
Standard Deviation 1.131
|
|
Testosterone
Month 12, Visit 6
|
8.00 NG/DL
Standard Deviation 4.243
|
-2.95 NG/DL
Standard Deviation 2.758
|
|
Testosterone
Month 13, Visit 7
|
14.00 NG/DL
|
2.00 NG/DL
|
|
Testosterone
Month 18, Visit 9
|
9.80 NG/DL
Standard Deviation 0.000
|
-1.15 NG/DL
Standard Deviation 1.485
|
|
Testosterone
Month 24, Visit 11
|
9.90 NG/DL
Standard Deviation 4.384
|
-1.05 NG/DL
Standard Deviation 2.899
|
|
Testosterone
Month 36, Visit 13
|
6.90 NG/DL
|
-3.00 NG/DL
|
|
Testosterone
Month 42, Visit 14
|
8.10 NG/DL
|
-1.80 NG/DL
|
|
Testosterone
Month 48, Visit 15
|
7.30 NG/DL
|
-2.60 NG/DL
|
|
Testosterone
Month 54, Visit 16
|
4.10 NG/DL
|
-5.80 NG/DL
|
|
Testosterone
Month 60, Visit 17
|
7.00 NG/DL
|
-2.90 NG/DL
|
|
Testosterone
6 Months Post Last Implant
|
17.00 NG/DL
|
7.10 NG/DL
|
|
Testosterone
12 Months Post Last Implant
|
130.00 NG/DL
|
120.10 NG/DL
|
SECONDARY outcome
Timeframe: Baseline - 36 Months Post Last ImplantPopulation: Extension Safety Population
DHEA=Dehydroepiandrosterone
Outcome measures
| Measure |
Observed Value
n=31 Participants
|
Change From Baseline
n=31 Participants
|
|---|---|---|
|
DHEA Sulfate
12 Months Post Last Implant
|
131.88 UG/DL
Standard Deviation 69.907
|
71.00 UG/DL
Standard Deviation 53.492
|
|
DHEA Sulfate
Month 18, Visit 9
|
83.25 UG/DL
Standard Deviation 47.973
|
27.79 UG/DL
Standard Deviation 20.381
|
|
DHEA Sulfate
Month 24, Visit 11
|
87.31 UG/DL
Standard Deviation 47.283
|
32.08 UG/DL
Standard Deviation 34.599
|
|
DHEA Sulfate
Month 36, Visit 13
|
78.50 UG/DL
Standard Deviation 72.809
|
37.45 UG/DL
Standard Deviation 50.794
|
|
DHEA Sulfate
Month 42, Visit 14
|
49.00 UG/DL
Standard Deviation 39.443
|
14.00 UG/DL
Standard Deviation 28.537
|
|
DHEA Sulfate
Month 48, Visit 15
|
80.00 UG/DL
Standard Deviation 50.292
|
36.56 UG/DL
Standard Deviation 39.313
|
|
DHEA Sulfate
Month 54, Visit 16
|
60.60 UG/DL
Standard Deviation 43.952
|
31.67 UG/DL
Standard Deviation 22.723
|
|
DHEA Sulfate
Month 60, Visit 17
|
89.44 UG/DL
Standard Deviation 34.667
|
53.14 UG/DL
Standard Deviation 25.635
|
|
DHEA Sulfate
Month 66, Visit 18
|
57.50 UG/DL
Standard Deviation 3.536
|
40.00 UG/DL
|
|
DHEA Sulfate
Month 72, Visit 19
|
41.00 UG/DL
Standard Deviation 4.243
|
23.00 UG/DL
|
|
DHEA Sulfate
6 Months Post Last Implant
|
114.25 UG/DL
Standard Deviation 50.692
|
61.43 UG/DL
Standard Deviation 28.148
|
|
DHEA Sulfate
24 Months Post Last Implant
|
195.00 UG/DL
Standard Deviation 98.995
|
140.50 UG/DL
Standard Deviation 84.146
|
|
DHEA Sulfate
36 Months Post Last Implant
|
184.00 UG/DL
|
119.00 UG/DL
|
|
DHEA Sulfate
Baseline
|
61.69 UG/DL
Standard Deviation 36.526
|
—
|
|
DHEA Sulfate
Month 3, Visit 3
|
70.88 UG/DL
Standard Deviation 46.802
|
11.67 UG/DL
Standard Deviation 15.281
|
|
DHEA Sulfate
Month 6, Visit 4
|
66.92 UG/DL
Standard Deviation 36.739
|
6.08 UG/DL
Standard Deviation 14.961
|
|
DHEA Sulfate
Month 9, Visit 5
|
71.22 UG/DL
Standard Deviation 45.057
|
12.16 UG/DL
Standard Deviation 15.085
|
|
DHEA Sulfate
Month 12, Visit 6
|
80.34 UG/DL
Standard Deviation 48.207
|
25.77 UG/DL
Standard Deviation 28.256
|
|
DHEA Sulfate
Month 13, Visit 7
|
81.00 UG/DL
Standard Deviation 43.624
|
23.42 UG/DL
Standard Deviation 23.178
|
SECONDARY outcome
Timeframe: Month 36 - 36 Months Post Last ImplantPopulation: Extension Safety Population
Long-term treatment with histrelin acetate suppresses the LH response to GnRH causing LH levels to decrease to prepubertal levels within 1 month of treatment. As a result, serum concentrations of sex steroids (estrogen or testosterone) also decrease. Estradiol suppression is defined as serum estradiol in the assay specific range \< 20 pg/mL (73 pmol/L) in girls following the induction of suppression.
Outcome measures
| Measure |
Observed Value
n=12 Participants
|
Change From Baseline
|
|---|---|---|
|
Estradiol (MS)
Month 36, Visit 13
|
0.46 NG/DL
Standard Deviation 0.277
|
—
|
|
Estradiol (MS)
Month 42, Visit 14
|
0.38 NG/DL
Standard Deviation 0.307
|
—
|
|
Estradiol (MS)
Month 48, Visit 15
|
0.52 NG/DL
Standard Deviation 0.319
|
—
|
|
Estradiol (MS)
Month 54, Visit 16
|
0.47 NG/DL
Standard Deviation 0.289
|
—
|
|
Estradiol (MS)
Month 60, Visit 17
|
0.50 NG/DL
Standard Deviation 0.201
|
—
|
|
Estradiol (MS)
Month 66, Visit 18
|
0.21 NG/DL
Standard Deviation 0.106
|
—
|
|
Estradiol (MS)
Month 72, Visit 19
|
0.34 NG/DL
Standard Deviation 0.205
|
—
|
|
Estradiol (MS)
6 Months Post Last Implant
|
2.38 NG/DL
Standard Deviation 0.909
|
—
|
|
Estradiol (MS)
12 Months Post Last Implant
|
4.00 NG/DL
Standard Deviation 2.810
|
—
|
|
Estradiol (MS)
24 Months Post Last Implant
|
2.70 NG/DL
Standard Deviation 0.424
|
—
|
|
Estradiol (MS)
36 Months Post Last Implant
|
3.10 NG/DL
|
—
|
SECONDARY outcome
Timeframe: Baseline - Month 24Population: Extension Safety Population
Long-term treatment with histrelin acetate suppresses the LH response to GnRH causing LH levels to decrease to prepubertal levels within 1 month of treatment. As a result, serum concentrations of sex steroids (estrogen or testosterone) also decrease. Estradiol suppression is defined as serum estradiol in the assay specific range \< 20 pg/mL (73 pmol/L) in girls following the induction of suppression.
Outcome measures
| Measure |
Observed Value
n=29 Participants
|
Change From Baseline
n=29 Participants
|
|---|---|---|
|
Estradiol (RIA)
Month 24, Visit 11
|
0.61 NG/DL
Standard Deviation 0.136
|
-0.48 NG/DL
Standard Deviation 1.119
|
|
Estradiol (RIA)
Baseline
|
1.58 NG/DL
Standard Deviation 1.754
|
—
|
|
Estradiol (RIA)
Day 1, Visit 1
|
0.50 NG/DL
|
0.00 NG/DL
|
|
Estradiol (RIA)
Month 1, Visit 2
|
0.58 NG/DL
Standard Deviation 0.199
|
-1.00 NG/DL
Standard Deviation 1.775
|
|
Estradiol (RIA)
Month 3, Visit 3
|
0.55 NG/DL
Standard Deviation 0.160
|
-1.03 NG/DL
Standard Deviation 1.765
|
|
Estradiol (RIA)
Month 6, Visit 4
|
0.52 NG/DL
Standard Deviation 0.061
|
-1.10 NG/DL
Standard Deviation 1.742
|
|
Estradiol (RIA)
Month 9, Visit 5
|
0.55 NG/DL
Standard Deviation 0.114
|
-1.06 NG/DL
Standard Deviation 1.794
|
|
Estradiol (RIA)
Month 12, Visit 6
|
0.72 NG/DL
Standard Deviation 0.526
|
-0.62 NG/DL
Standard Deviation 1.599
|
|
Estradiol (RIA)
Month 13, Visit 7
|
0.57 NG/DL
Standard Deviation 0.184
|
-1.05 NG/DL
Standard Deviation 1.806
|
|
Estradiol (RIA)
Month 18, Visit 9
|
0.61 NG/DL
Standard Deviation 0.154
|
-0.69 NG/DL
Standard Deviation 1.670
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Extension Safety Population
There were 2 implants received that were not removed during the study and were excluded from this analysis due to unknown duration of treatment.
Outcome measures
| Measure |
Observed Value
n=31 Participants
|
Change From Baseline
|
|---|---|---|
|
Average Number of Implants Received
|
3.5 Implants
Standard Deviation 1.36
|
—
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Extension Safety Population
There were 2 implants received that were not removed during the study and were excluded from this analysis due to unknown duration of treatment.
Outcome measures
| Measure |
Observed Value
n=31 Participants
|
Change From Baseline
|
|---|---|---|
|
Average Mean Implant Duration by Subject
|
12.62 Months
Standard Deviation 0.469
|
—
|
SECONDARY outcome
Timeframe: Day 1 - Month 60Population: Extension Safety Population
Once the female participants reached 11 years of age and the male participants reached 12 years of age or the investigator determined that subjects no longer required hormone suppression, participants underwent final explantation and were eligible to continue into an optional Long Term Follow Up Phase (Post Implant Treatment Phase) for up to 5 years. The purpose of the optional Long Term Follow Up Phase was to collect additional medical and developmental information, such as onset of menses and final adult height after hormone suppression was discontinued.
Outcome measures
| Measure |
Observed Value
n=31 Participants
|
Change From Baseline
n=31 Participants
|
|---|---|---|
|
Summary of EN3326 Implantation and Explantations
First Implant (Day 1, Visit 1)
|
31 Participants
|
31 Participants
|
|
Summary of EN3326 Implantation and Explantations
Second Implant (Month 12, Visit 6)
|
31 Participants
|
31 Participants
|
|
Summary of EN3326 Implantation and Explantations
Third Implant (Month 24, Visit 11)
|
22 Participants
|
22 Participants
|
|
Summary of EN3326 Implantation and Explantations
Fourth Implant (Month 36, Visit 13)
|
13 Participants
|
13 Participants
|
|
Summary of EN3326 Implantation and Explantations
Fifth Implant (Month 48, Visit 15)
|
11 Participants
|
9 Participants
|
|
Summary of EN3326 Implantation and Explantations
Sixth Implant (Month 60, Visit 17)
|
2 Participants
|
2 Participants
|
Adverse Events
Overall - Histrelin Subcutaneous Implant (50 mg)
Serious events: 3 serious events
Other events: 31 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Overall - Histrelin Subcutaneous Implant (50 mg)
n=31 participants at risk
Subcutaneous implant designed to deliver histrelin continously for 12 months.
Histrelin Subcutaneous Implant: histrelin subcutaneous 50 mg implant
|
|---|---|
|
Psychiatric disorders
Aggression
|
6.5%
2/31 • From start of 2nd implant period through end of 6th implant period up to 48 months.
|
|
Psychiatric disorders
Depression
|
3.2%
1/31 • From start of 2nd implant period through end of 6th implant period up to 48 months.
|
|
Infections and infestations
Bronchopneumonia
|
3.2%
1/31 • From start of 2nd implant period through end of 6th implant period up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
3.2%
1/31 • From start of 2nd implant period through end of 6th implant period up to 48 months.
|
Other adverse events
| Measure |
Overall - Histrelin Subcutaneous Implant (50 mg)
n=31 participants at risk
Subcutaneous implant designed to deliver histrelin continously for 12 months.
Histrelin Subcutaneous Implant: histrelin subcutaneous 50 mg implant
|
|---|---|
|
General disorders
Implant Site Reaction
|
64.5%
20/31 • From start of 2nd implant period through end of 6th implant period up to 48 months.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
25.8%
8/31 • From start of 2nd implant period through end of 6th implant period up to 48 months.
|
|
Infections and infestations
Nasopharyngitis
|
19.4%
6/31 • From start of 2nd implant period through end of 6th implant period up to 48 months.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
16.1%
5/31 • From start of 2nd implant period through end of 6th implant period up to 48 months.
|
|
Infections and infestations
Sinusitis
|
12.9%
4/31 • From start of 2nd implant period through end of 6th implant period up to 48 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.9%
4/31 • From start of 2nd implant period through end of 6th implant period up to 48 months.
|
|
Nervous system disorders
Headache
|
19.4%
6/31 • From start of 2nd implant period through end of 6th implant period up to 48 months.
|
|
Investigations
Weight Increased
|
12.9%
4/31 • From start of 2nd implant period through end of 6th implant period up to 48 months.
|
|
Psychiatric disorders
Agression
|
9.7%
3/31 • From start of 2nd implant period through end of 6th implant period up to 48 months.
|
|
Psychiatric disorders
Depression
|
6.5%
2/31 • From start of 2nd implant period through end of 6th implant period up to 48 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place