Central Precocious Puberty
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study is to evaluate the long-term safety and efficacy of Enantone in the treatment of CPP in Chinese participants.
Detailed description
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.
Interventions
DRUGEnantone
Enantone suspension for injection
DRUGGnRH agonist
A non-Enantone GnRH agonist
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Has diagnosis of idiopathic CPP. 2. Has been treated with leuprorelin acetate (Enantone) for at least 9 continuous months of therapy with either a stable dose of high dose (greater than or equal to \[\>=\] 90 mcg/kg up to 180 mcg/kg) or low dose (\< 90 mcg/kg down to 30 mcg/kg). 3. Has initiated and completed treatment during the index period from September 1st 1998 to September 30th 2018. 4. Have the following information prior to initiation of enantone and at least one record of each of the following parameters at the end of enantone treatment in the medical records: Tanner staging, estradiol or testosterone level, and FSH and LH level. The participant should have at least one record of bone age prior to the initiation gonadotropin releasing hormone analogs (GnRHa) therapy with enantone to support the diagnosis of CPP. In addition, should have at least one record of bone age during treatment with enantone.
Exclusion criteria
1. Has been treated with leuprorelin acetate or any other GnRHa for conditions other than CPP. 2. Has used any other GnRHa products for CPP treatment prior to initiation of enantone therapy. 3. CPP participants with identified etiology, such as brain tumor or cranial irradiation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase | 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) | 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. |
| Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase | 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) | 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. |
| Percentage of Participants Who Had Regression or No Progression in Tanner Staging at the End of Enantone Treatment Phase | The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months | 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. |
| Percentage of Participants Who Had Regression or No Progression in Tanner Staging at the End of Follow-Up Phase | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Decease of Ratio of Bone Age to Chronological Age at the End of Enantone Treatment Phase | 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. |
| 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 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. |
| Percentage of Participants With Decease of Ratio of Bone Age to Chronological Age at the End of Follow-up Phase | 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. |
| 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 | 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 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. |
| Percentage of Participants With Value, for Estradiol or Testosterone, Suppressed Below Upper Limit Value (ULV) at the End of Enantone Treatment Phase | The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months | 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. |
| Percentage of Participants With Value, for Estradiol or Testosterone, Suppressed Below Upper Limit Value (ULV) at the End of Follow-Up Phase | 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 | 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. |
Countries
China
Participant flow
Recruitment details
Participants took part in the study at 6 investigative sites in China from 24 Jun 2017 to 30 Sep 2018.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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). | 108 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 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
| Characteristic | Treatment Phase: Enantone | — |
|---|---|---|
| Age, Continuous | 8.45 years STANDARD_DEVIATION 1.124 | — |
| Bone Age/Chronological Age Ratio | 1.22 ratio STANDARD_DEVIATION 0.122 | — |
| Estradiol | 23.3453 ng/L STANDARD_DEVIATION 18.1633 | — |
| Peak Stimulated Follicle Stimulating Hormone (FSH) | 14.407 U/L STANDARD_DEVIATION 5.9366 | — |
| Peak Stimulated Luteinizing Hormone (LH) | 16.935 U/L STANDARD_DEVIATION 10.7717 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment China | 108 Participants | — |
| Sex: Female, Male Female | 104 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
| Tanner Staging Evaluation Breast (Female) and Genitals (Male), Stage I | 1 Participants | — |
| Tanner Staging Evaluation Breast (Female) and Genitals (Male), Stage II | 49 Participants | — |
| Tanner Staging Evaluation Breast (Female) and Genitals (Male), Stage III | 46 Participants | — |
| Tanner Staging Evaluation Breast (Female) and Genitals (Male), Stage IV | 3 Participants | — |
| Tanner Staging Evaluation Pubic Hair, Stage I | 75 Participants | — |
| Tanner Staging Evaluation Pubic Hair, Stage II | 14 Participants | — |
| Testosterone | 70.4653 pg/mL STANDARD_DEVIATION 127.7357 | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 108 | 0 / 44 | 0 / 26 |
| other Total, other adverse events | 63 / 108 | 0 / 44 | 9 / 26 |
| serious Total, serious adverse events | 2 / 108 | 0 / 44 | 0 / 26 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Phase: Enantone (Male) | Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase | TEAE | 4 Participants |
| Treatment Phase: Enantone (Male) | Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase | SAE | 0 Participants |
| Treatment Phase: Enantone (Female) | Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase | TEAE | 71 Participants |
| Treatment Phase: Enantone (Female) | Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase | SAE | 2 Participants |
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Phase: Enantone (Male) | Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase | TEAE | 0 Participants |
| Treatment Phase: Enantone (Male) | Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase | SAE | 0 Participants |
| Treatment Phase: Enantone (Female) | Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase | TEAE | 10 Participants |
| Treatment Phase: Enantone (Female) | Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase | SAE | 0 Participants |
| FollowUp:Treated With Non-Enantone GnRHa After Enantone-Female | Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase | TEAE | 9 Participants |
| FollowUp:Treated With Non-Enantone GnRHa After Enantone-Female | Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase | SAE | 0 Participants |
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Phase: Enantone (Male) | Percentage of Participants Who Had Regression or No Progression in Tanner Staging at the End of Enantone Treatment Phase | 0 percentage of participants |
| Treatment Phase: Enantone (Female) | Percentage of Participants Who Had Regression or No Progression in Tanner Staging at the End of Enantone Treatment Phase | 79.7 percentage of participants |
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FollowUp:Treated With Non-Enantone GnRHa After Enantone-Female | Percentage of Participants Who Had Regression or No Progression in Tanner Staging at the End of Follow-Up Phase | 0 percentage of participants |
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Phase: Enantone (Male) | 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 |
| Treatment Phase: Enantone (Female) | Percentage of Participants With Decease of Ratio of Bone Age to Chronological Age at the End of Enantone Treatment Phase | 90.2 percentage of participants |
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.
Time frame: 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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Phase: Enantone (Female) | Percentage of Participants With Decease of Ratio of Bone Age to Chronological Age at the End of Follow-up Phase | 100 percentage of participants |
| FollowUp:Treated With Non-Enantone GnRHa After Enantone-Female | Percentage of Participants With Decease of Ratio of Bone Age to Chronological Age at the End of Follow-up Phase | 100 percentage of participants |
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Phase: Enantone (Male) | 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 |
| Treatment Phase: Enantone (Male) | 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 |
| Treatment Phase: Enantone (Female) | 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 | 98.1 percentage of participants |
| Treatment Phase: Enantone (Female) | 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 |
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.
Time frame: 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.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | 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 | LH (U/L) Peak Value ≤ ULV | — |
| Unknown | 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 | FSH (U/L) Peak Value ≤ ULV | — |
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Phase: Enantone (Male) | 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 |
| Treatment Phase: Enantone (Female) | Percentage of Participants With Value, for Estradiol or Testosterone, Suppressed Below Upper Limit Value (ULV) at the End of Enantone Treatment Phase | 74.8 percentage of participants |
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Phase: Enantone (Female) | 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 |
| FollowUp:Treated With Non-Enantone GnRHa After Enantone-Female | 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 |