Trial Outcomes & Findings for A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants (NCT NCT02993926)

Last Updated: 2022-03-16

Results Overview

A TEAE is any untoward medical occurrence in a subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Recruitment status

COMPLETED

Target enrollment

108 participants

Primary outcome timeframe

During treatment with and up to 30 days post last dose of Enantone (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months)

Results posted on

2022-03-16

Participant Flow

Participants took part in the study at 6 investigative sites in China from 24 Jun 2017 to 30 Sep 2018.

Participants with a diagnosis of central precocious puberty (CPP) who previously received Enantone for at least 9 continuous months in clinical practice index period: 1 September 1998 to 30 September 2018 were enrolled in this study.

Participant milestones

Participant milestones
Measure	Treatment Phase: Enantone Participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).	Follow Up: Participants No Longer Treated for CPP Participants who had completed their CPP during the treatment phase with Enantone and were no longer on treatment in the follow-up phase (the mean duration of follow up was 8.75 months with a range of 1.9 to 29.5 months).	Follow Up: Treated With Non-Enantone GnRHa After Enantone Participants who were continuing their CPP treatment with a non-Enantone gonadotropin releasing hormone agonist (GnRHa) after treatment with Enantone in the follow-up phase (the mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months, and the mean duration of follow up after stopping treatment was 4.26 months with a range of 0.0 \[i.e. 1 day\] to 12 months).
Enantone Treatment Phase STARTED	108	0	0
Enantone Treatment Phase COMPLETED	76	0	0
Enantone Treatment Phase NOT COMPLETED	32	0	0
Follow-Up Phase STARTED	0	44	26
Follow-Up Phase COMPLETED	0	44	26
Follow-Up Phase NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Phase: Enantone Participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).	Follow Up: Participants No Longer Treated for CPP Participants who had completed their CPP during the treatment phase with Enantone and were no longer on treatment in the follow-up phase (the mean duration of follow up was 8.75 months with a range of 1.9 to 29.5 months).	Follow Up: Treated With Non-Enantone GnRHa After Enantone Participants who were continuing their CPP treatment with a non-Enantone gonadotropin releasing hormone agonist (GnRHa) after treatment with Enantone in the follow-up phase (the mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months, and the mean duration of follow up after stopping treatment was 4.26 months with a range of 0.0 \[i.e. 1 day\] to 12 months).
Enantone Treatment Phase Adverse Event	1	0	0
Enantone Treatment Phase Changed CPP Therapy to Another GnRHa	26	0	0
Enantone Treatment Phase Investigator Judgment	1	0	0
Enantone Treatment Phase Reason Not Specified	4	0	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Phase: Enantone n=108 Participants Participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).
Age, Continuous	8.45 years STANDARD_DEVIATION 1.124 • n=108 Participants
Sex: Female, Male Female	104 Participants n=108 Participants
Sex: Female, Male Male	4 Participants n=108 Participants
Region of Enrollment China	108 Participants n=108 Participants
Tanner Staging Evaluation Breast (Female) and Genitals (Male), Stage I	1 Participants n=108 Participants
Tanner Staging Evaluation Breast (Female) and Genitals (Male), Stage II	49 Participants n=108 Participants
Tanner Staging Evaluation Breast (Female) and Genitals (Male), Stage III	46 Participants n=108 Participants
Tanner Staging Evaluation Breast (Female) and Genitals (Male), Stage IV	3 Participants n=108 Participants
Tanner Staging Evaluation Pubic Hair, Stage I	75 Participants n=108 Participants
Tanner Staging Evaluation Pubic Hair, Stage II	14 Participants n=108 Participants
Peak Stimulated Luteinizing Hormone (LH)	16.935 U/L STANDARD_DEVIATION 10.7717 • n=108 Participants
Peak Stimulated Follicle Stimulating Hormone (FSH)	14.407 U/L STANDARD_DEVIATION 5.9366 • n=108 Participants
Estradiol	23.3453 ng/L STANDARD_DEVIATION 18.1633 • n=108 Participants
Testosterone	70.4653 pg/mL STANDARD_DEVIATION 127.7357 • n=108 Participants
Bone Age/Chronological Age Ratio	1.22 ratio STANDARD_DEVIATION 0.122 • n=108 Participants

PRIMARY outcome

Timeframe: During treatment with and up to 30 days post last dose of Enantone (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months)

Population: Safety Analysis Set included all enrolled participants. Data in this outcome measure is reported separately for male and female participants.

Outcome measures

Outcome measures
Measure	Treatment Phase: Enantone (Male) n=4 Participants Male participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).	Treatment Phase: Enantone (Female) n=104 Participants Female participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).	FollowUp:Treated With Non-Enantone GnRHa After Enantone-Female Female participants who were continuing their CPP treatment with a non-Enantone GnRHa after treatment with Enantone in the follow-up phase (the mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months, and the mean duration of follow up after stopping treatment was 4.26 months with a range of 0.0 \[i.e. 1 day\] to 12 months).
Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase TEAE	4 Participants	71 Participants	—
Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase SAE	0 Participants	2 Participants	—

PRIMARY outcome

Timeframe: Mean duration of follow-up=8.75 months (range: 1.9-29.5 months) for No longer treated for CPP group; 10.80 months (range: 2.8-20.5 months) for Treated with Non-Enantone GnRHa group after treatment with Enantone (while on another GnRHa)

Population: Safety Analysis Set included all enrolled participants. Data in this outcome measure is reported separately for male and female participants for follow-up period. There were no observations available for male participants who continued therapy with a Non-Enantone GnRHa in the follow-up period.

Outcome measures

Outcome measures
Measure	Treatment Phase: Enantone (Male) n=2 Participants Male participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).	Treatment Phase: Enantone (Female) n=42 Participants Female participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).	FollowUp:Treated With Non-Enantone GnRHa After Enantone-Female n=26 Participants Female participants who were continuing their CPP treatment with a non-Enantone GnRHa after treatment with Enantone in the follow-up phase (the mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months, and the mean duration of follow up after stopping treatment was 4.26 months with a range of 0.0 \[i.e. 1 day\] to 12 months).
Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase TEAE	0 Participants	10 Participants	9 Participants
Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase SAE	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months

Population: Full Analysis Set (FAS) included all enrolled participants. Number of participants analyzed is the number of male or female participants with data available for the analysis of this outcome measure at the end of Treatment Phase.

Tanner Stage is used to measure pubertal development. Female (F) and male (M) participants were evaluated for breast development and genital development respectively and both genders for pubic hair development. Tanner Stage is based on progression through 5-stages. Participants were classified as having progression if either breast/genitals or pubic hair progression were present. Otherwise participant is classified as regression or no progression.

Outcome measures

Outcome measures
Measure	Treatment Phase: Enantone (Male) n=1 Participants Male participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).	Treatment Phase: Enantone (Female) n=79 Participants Female participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).	FollowUp:Treated With Non-Enantone GnRHa After Enantone-Female Female participants who were continuing their CPP treatment with a non-Enantone GnRHa after treatment with Enantone in the follow-up phase (the mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months, and the mean duration of follow up after stopping treatment was 4.26 months with a range of 0.0 \[i.e. 1 day\] to 12 months).
Percentage of Participants Who Had Regression or No Progression in Tanner Staging at the End of Enantone Treatment Phase	0 percentage of participants Interval 0.0 to 97.5	79.7 percentage of participants Interval 69.2 to 87.96	—

PRIMARY outcome

Timeframe: No longer treated for CPP group - Month: 27 (766- 855 days) post last dose of Enantone; Treated with Non-Enantone GnRHa group - Month 21 (586- 675 days) post last dose of Enantone

Population: FAS included all enrolled participants. Number of participants analyzed is the number of male or female participants with data available for analysis of this outcome measure at the end of Follow-up Phase. There were no observations available for male participants who continued therapy with a Non-Enantone GnRHa in the follow-up period.

Outcome measures

Outcome measures
Measure	Treatment Phase: Enantone (Male) Male participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).	Treatment Phase: Enantone (Female) Female participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).	FollowUp:Treated With Non-Enantone GnRHa After Enantone-Female n=1 Participants Female participants who were continuing their CPP treatment with a non-Enantone GnRHa after treatment with Enantone in the follow-up phase (the mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months, and the mean duration of follow up after stopping treatment was 4.26 months with a range of 0.0 \[i.e. 1 day\] to 12 months).
Percentage of Participants Who Had Regression or No Progression in Tanner Staging at the End of Follow-Up Phase	—	—	0 percentage of participants Interval 0.0 to 97.5

SECONDARY outcome

Timeframe: The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months

The LH suppression is defined as peak LH ≤2 U/L for female and peak LH ≤2.7 U/L for male. The FSH suppression is defined as peak FSH ≤6.7 U/L for female and peak FSH ≤3.7 U/L for male. Post Stimulation Test, the peak values for LH and FSH suppression below Upper Limit Value (ULV) are reported.

Outcome measures

Outcome measures
Measure	Treatment Phase: Enantone (Male) n=1 Participants Male participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).	Treatment Phase: Enantone (Female) n=52 Participants Female participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).	FollowUp:Treated With Non-Enantone GnRHa After Enantone-Female Female participants who were continuing their CPP treatment with a non-Enantone GnRHa after treatment with Enantone in the follow-up phase (the mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months, and the mean duration of follow up after stopping treatment was 4.26 months with a range of 0.0 \[i.e. 1 day\] to 12 months).
Percentage of Participants With Post Stimulation Test Peak Values, for Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH), Suppressed Below Upper Limit Value (ULV) at the End of Enantone Treatment Phase LH (U/L) Peak Value ≤ ULV	100 percentage of participants Interval 2.5 to 100.0	98.1 percentage of participants Interval 89.74 to 99.95	—
Percentage of Participants With Post Stimulation Test Peak Values, for Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH), Suppressed Below Upper Limit Value (ULV) at the End of Enantone Treatment Phase FSH (U/L) Peak Value ≤ ULV	100 percentage of participants Interval 2.5 to 100.0	100 percentage of participants Interval 93.15 to 100.0	—

SECONDARY outcome

Timeframe: No longer treated for CPP group - Month: 27 (766- 855 days) post last dose of Enantone; Treated with Non-Enantone GnRHa group - Month 21 (586- 675 days) post last dose of Enantone

Population: No data were available for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months

Population: FAS included all enrolled participants. Number of participants analyzed is the number of male or female participants with data available for analysis of this outcome measure at the end of Treatment Phase. There were no observations available for male participants who continued therapy with a Non-Enantone GnRHa in the follow-up period.

Estradiol or Testosterone, suppressed below Upper Limit Value (ULV) were reported. The ULV for estradiol and testosterone were 20 pg/mL and 7.34 nmol/L, respectively.

Outcome measures

Outcome measures
Measure	Treatment Phase: Enantone (Male) n=4 Participants Male participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).	Treatment Phase: Enantone (Female) n=103 Participants Female participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).	FollowUp:Treated With Non-Enantone GnRHa After Enantone-Female Female participants who were continuing their CPP treatment with a non-Enantone GnRHa after treatment with Enantone in the follow-up phase (the mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months, and the mean duration of follow up after stopping treatment was 4.26 months with a range of 0.0 \[i.e. 1 day\] to 12 months).
Percentage of Participants With Value, for Estradiol or Testosterone, Suppressed Below Upper Limit Value (ULV) at the End of Enantone Treatment Phase	100 percentage of participants Interval 39.76 to 100.0	74.8 percentage of participants Interval 65.24 to 82.8	—

SECONDARY outcome

Timeframe: No longer treated for CPP group-Month: 27 (766-855 days) post last dose of Enantone; Treated with Non-Enantone GnRHa group-Month 21 (586-675 days) post last dose of Enantone

Population: FAS included all enrolled participants. Number of participants analyzed is the number of male or female participants with data available for analysis of analysis at the end of Follow-up Phase. There were no observations available for male participants who continued therapy with a Non-Enantone GnRHa in the follow-up period.

Estradiol or Testosterone, suppressed below Upper Limit Value (ULV) were reported. The ULV for estradiol and testosterone were 20 pg/mL and 7.34 nmol/L, respectively.

Outcome measures

Outcome measures
Measure	Treatment Phase: Enantone (Male) Male participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).	Treatment Phase: Enantone (Female) n=1 Participants Female participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).	FollowUp:Treated With Non-Enantone GnRHa After Enantone-Female n=1 Participants Female participants who were continuing their CPP treatment with a non-Enantone GnRHa after treatment with Enantone in the follow-up phase (the mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months, and the mean duration of follow up after stopping treatment was 4.26 months with a range of 0.0 \[i.e. 1 day\] to 12 months).
Percentage of Participants With Value, for Estradiol or Testosterone, Suppressed Below Upper Limit Value (ULV) at the End of Follow-Up Phase	—	0 percentage of participants Interval 0.0 to 97.5	0 percentage of participants Interval 0.0 to 97.5

SECONDARY outcome

Timeframe: The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months

Bone age (BA) was estimated using an X-ray. Chronological age (CA) at the date of corresponding X-ray (Date of X-ray - Date of birth)/365.25. Ratio of BA/CA was calculated.

Outcome measures

Outcome measures
Measure	Treatment Phase: Enantone (Male) n=4 Participants Male participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).	Treatment Phase: Enantone (Female) n=92 Participants Female participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).	FollowUp:Treated With Non-Enantone GnRHa After Enantone-Female Female participants who were continuing their CPP treatment with a non-Enantone GnRHa after treatment with Enantone in the follow-up phase (the mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months, and the mean duration of follow up after stopping treatment was 4.26 months with a range of 0.0 \[i.e. 1 day\] to 12 months).
Percentage of Participants With Decease of Ratio of Bone Age to Chronological Age at the End of Enantone Treatment Phase	75.0 percentage of participants Interval 19.41 to 99.37	90.2 percentage of participants Interval 82.24 to 95.43	—

SECONDARY outcome

Timeframe: No longer treated for CPP group - Month: 27 (766- 855 days) post last dose of Enantone; Treated with Non-Enantone GnRHa group - Month 18 (496-585 days) post last dose of Enantone

Bone age (BA) was estimated using an X-ray. Chronological age (CA) at the date of corresponding X-ray (Date of X-ray - Date of birth)/365.25. Ratio of BA/CA was calculated.

Outcome measures

Outcome measures
Measure	Treatment Phase: Enantone (Male) Male participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).	Treatment Phase: Enantone (Female) n=2 Participants Female participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).	FollowUp:Treated With Non-Enantone GnRHa After Enantone-Female n=3 Participants Female participants who were continuing their CPP treatment with a non-Enantone GnRHa after treatment with Enantone in the follow-up phase (the mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months, and the mean duration of follow up after stopping treatment was 4.26 months with a range of 0.0 \[i.e. 1 day\] to 12 months).
Percentage of Participants With Decease of Ratio of Bone Age to Chronological Age at the End of Follow-up Phase	—	100 percentage of participants Interval 15.81 to 100.0	100 percentage of participants Interval 29.24 to 100.0

Adverse Events

Treatment Phase: Enantone

Serious events: 2 serious events

Other events: 63 other events

Deaths: 0 deaths

Follow Up: Participants No Longer Treated for CPP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Follow Up: Treated With Non-Enantone GnRHa After Enantone

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Phase: Enantone n=108 participants at risk Participants with CPP who were treated with Enantone (≥ 30 μg/kg up to 180 μg/kg) for at least 9 continuous months and who initiated and received the last dose of treatment during the index period from 01 September 1998 to 30 September 2018 (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months).	Follow Up: Participants No Longer Treated for CPP n=44 participants at risk Participants who had completed their CPP during the treatment phase with Enantone and were no longer on treatment in the follow-up phase (the mean duration of follow up was 8.75 months with a range of 1.9 to 29.5 months).	Follow Up: Treated With Non-Enantone GnRHa After Enantone n=26 participants at risk Participants who were continuing their CPP treatment with a non-Enantone gonadotropin releasing hormone agonist (GnRHa) after treatment with Enantone in the follow-up phase (the mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months, and the mean duration of follow up after stopping treatment was 4.26 months with a range of 0.0 \[i.e. 1 day\] to 12 months).
Infections and infestations Pneumonia	0.93% 1/108 • Treatment Phase - During treatment with Enantone and up to 30 days post last dose of Enantone (mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months); Follow-up Phase: No Longer Treated for CPP group - mean duration of follow up was 8.75 months with a range of 1.9 to 29.5 months; Treated with Non-Enantone GnRHa group - mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months.	0.00% 0/44 • Treatment Phase - During treatment with Enantone and up to 30 days post last dose of Enantone (mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months); Follow-up Phase: No Longer Treated for CPP group - mean duration of follow up was 8.75 months with a range of 1.9 to 29.5 months; Treated with Non-Enantone GnRHa group - mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months.	0.00% 0/26 • Treatment Phase - During treatment with Enantone and up to 30 days post last dose of Enantone (mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months); Follow-up Phase: No Longer Treated for CPP group - mean duration of follow up was 8.75 months with a range of 1.9 to 29.5 months; Treated with Non-Enantone GnRHa group - mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hair follicle tumour benign	0.93% 1/108 • Treatment Phase - During treatment with Enantone and up to 30 days post last dose of Enantone (mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months); Follow-up Phase: No Longer Treated for CPP group - mean duration of follow up was 8.75 months with a range of 1.9 to 29.5 months; Treated with Non-Enantone GnRHa group - mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months.	0.00% 0/44 • Treatment Phase - During treatment with Enantone and up to 30 days post last dose of Enantone (mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months); Follow-up Phase: No Longer Treated for CPP group - mean duration of follow up was 8.75 months with a range of 1.9 to 29.5 months; Treated with Non-Enantone GnRHa group - mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months.	0.00% 0/26 • Treatment Phase - During treatment with Enantone and up to 30 days post last dose of Enantone (mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months); Follow-up Phase: No Longer Treated for CPP group - mean duration of follow up was 8.75 months with a range of 1.9 to 29.5 months; Treated with Non-Enantone GnRHa group - mean duration of follow up while on another GnRHa was 10.80 months with a range of 2.8 to 20.5 months.

Other adverse events

Additional Information

Medical Director

Takeda

Phone: 877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All publications and presentations must be prepared in accordance with this section and the Clinical Study Site Agreement.
Publication restrictions are in place

Restriction type: OTHER