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The purpose of this study is to evaluate the long-term safety and efficacy of Enantone in the treatment of CPP in Chinese participants.
The drug being evaluated in this study is called Enantone (leuprorelin). Enantone is used to treat children who have CPP. This study will look at long term safety and efficacy of leuprorelin in the treatment of Chinese participants with CPP.
The study will enroll approximately 300 participants.
All participants who have received leuprorelin 30 mcg/kg to <90 mcg/kg or 90 mcg/kg to 180 mcg/kg per body weight, injection, subcutaneously, every 4 weeks up to at least 9 continuous months during the index period from September 1st 1998 to September 30th 2018 will be observed.
This multi-center trial will be conducted in China. Data will be collected over period of 20 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enantone | Drug | Enantone suspension for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase | 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. | 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) |
| Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase | 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. | 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) |
| Percentage of Participants Who Had Regression or No Progression in Tanner Staging at the End of Enantone 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. | The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants diagnosed with CPP will be observed.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital, Zhejiang University School of Medicine | Wuhan | Hubei | 430030 | China | ||
| Childrens Hospital of Hunan province |
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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.
Participants took part in the study at 6 investigative sites in China from 24 Jun 2017 to 30 Sep 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| FG002 | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enantone Treatment Phase |
|
| |||||||||||||||||||||
| Follow-Up Phase |
|
Safety Analysis Set included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age presented here is age at enantone treatment initiation (Years). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase | 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. | Safety Analysis Set included all enrolled participants. Data in this outcome measure is reported separately for male and female participants. | Posted | Count of Participants | Participants | 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) |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
The enrollment of only 100 participants did not support the performance of subgroup analysis of outcomes by dose. Retrospective observational data is not controlled and therefore robust analysis could not be performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | 877-825-3327 | +1 | trialdisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 26, 2018 | Sep 30, 2019 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 22, 2019 | Sep 30, 2019 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D011629 | Puberty, Precocious |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| D007987 | Gonadotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| GnRH agonist | Drug | A non-Enantone GnRH agonist |
|
| Percentage of Participants Who Had Regression or No Progression in Tanner Staging at the End of Follow-Up 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. | 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 |
| The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 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 Follow-Up Phase | 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. | 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 |
| Percentage of Participants With Value, for Estradiol or Testosterone, Suppressed Below Upper Limit Value (ULV) at the End of Enantone Treatment Phase | 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. | The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months |
| Percentage of Participants With Value, for Estradiol or Testosterone, Suppressed Below Upper Limit Value (ULV) at the End of Follow-Up Phase | 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. | 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 |
| Percentage of Participants With Decease of Ratio of Bone Age to Chronological Age at the End of Enantone Treatment Phase | 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. | The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months |
| Percentage of Participants With Decease of Ratio of Bone Age to Chronological Age at the End of Follow-up Phase | 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. | 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 |
| Changsha |
| Hunan |
| 410007 |
| China |
| Jiangsu Province Hosptial | Nanjing | Jiangsu | 210036 | China |
| Children's Hospital of Jiangxi province | Nanchang | Jiangxi | 330006 | China |
| Children's Hospital of Shanghai | Shanghai | Shanghai Municipality | 200040 | China |
| The Children's Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310053 | China |
| Investigator Judgment |
|
| Reason Not Specified |
|
| NOT COMPLETED |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Tanner Staging Evaluation | Tanner Stage is used to define physical measurements of sexual development based on external primary and secondary sex characteristics. Female and male participants were evaluated for breast development and genital development respectively and both genders for pubic hair distribution based on a 5-stage scale ranging from Stage I (prepubertal/preadolescent characteristics) to Stage V (mature or adult characteristics). Participants classified as having progression if either breast/genitals or pubic hair were present. Otherwise participant is classified as regression or no progression. | Count of Participants | Participants |
|
| Peak Stimulated Luteinizing Hormone (LH) | Mean | Standard Deviation | U/L |
|
| Peak Stimulated Follicle Stimulating Hormone (FSH) | Mean | Standard Deviation | U/L |
|
| Estradiol | Mean | Standard Deviation | ng/L |
|
| Testosterone | Mean | Standard Deviation | pg/mL |
|
| Bone Age/Chronological Age Ratio | 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. | Mean | Standard Deviation | ratio |
|
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). |
| OG001 | 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). |
|
|
| Primary | Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase | 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. | 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. | Posted | Count of Participants | Participants | 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) |
|
|
|
| Primary | Percentage of Participants Who Had Regression or No Progression in Tanner Staging at the End of Enantone 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months |
|
|
|
| Primary | Percentage of Participants Who Had Regression or No Progression in Tanner Staging at the End of Follow-Up 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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 |
|
|
|
| Secondary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months |
|
|
|
| Secondary | 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 Follow-Up Phase | 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. | No data were available for this outcome measure. | Posted | 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 |
|
|
|
| Secondary | Percentage of Participants With Value, for Estradiol or Testosterone, Suppressed Below Upper Limit Value (ULV) at the End of Enantone Treatment Phase | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months |
|
|
|
| Secondary | Percentage of Participants With Value, for Estradiol or Testosterone, Suppressed Below Upper Limit Value (ULV) at the End of Follow-Up Phase | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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 |
|
|
|
| Secondary | Percentage of Participants With Decease of Ratio of Bone Age to Chronological Age at the End of Enantone Treatment Phase | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months |
|
|
|
| Secondary | Percentage of Participants With Decease of Ratio of Bone Age to Chronological Age at the End of Follow-up Phase | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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 |
|
|
|
| 0 |
| 108 |
| 2 |
| 108 |
| 63 |
| 108 |
| EG001 | 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). | 0 | 44 | 0 | 44 | 0 | 44 |
| EG002 | 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). | 0 | 26 | 0 | 26 | 9 | 26 |
| Hair follicle tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Growth retardation | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Refraction disorder | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Bone density decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Growth hormone deficiency | Endocrine disorders | MedDRA 21.0 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Immunodeficiency | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Keratosis follicular | Congenital, familial and genetic disorders | MedDRA 21.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vulvitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
All publications and presentations must be prepared in accordance with this section and the Clinical Study Site Agreement.
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| Title | Measurements |
|---|---|
|