Trial · NCT02993926
A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants
NCT02993926, Completed, Takeda; results first posted 2019-10-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants. Trials, record NCT02993926. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02993926
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants
- NCT number
- NCT02993926
- Status
- Completed
- Enrollment
- 108 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Central Precocious Puberty
- Interventions
- Enantone, GnRH agonist
- First posted
- 2016-12-15
- Last updated
- 2022-03-16
- Results first posted
- 2019-10-24
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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 | 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. |
| 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | Safety Analysis Set included all enrolled participants. Data in this outcome measure is reported separately for male and female participants. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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 | 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. | percentage of participants | NUMBER |
| PRIMARY | 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 | 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. | percentage of participants | NUMBER |
| 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 mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months | 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. | percentage of participants | NUMBER |
| 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 | 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 | No data were available for this outcome measure. | ||
| SECONDARY | 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 | 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. | percentage of participants | NUMBER |
| SECONDARY | 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 | 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. | percentage of participants | NUMBER |
| SECONDARY | 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 | 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. | percentage of participants | NUMBER |
| SECONDARY | 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 | 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. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase | Treatment Phase: Enantone (Male) | TEAE | 4 | Participants | |
| Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase | Treatment Phase: Enantone (Female) | TEAE | 71 | Participants | |
| Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase | Treatment Phase: Enantone (Male) | SAE | 0 | Participants | |
| Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase | Treatment Phase: Enantone (Female) | SAE | 2 | Participants | |
| Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase | Follow UP: Participants No Longer Treated for CPP (Male) | TEAE | 0 | Participants | |
| Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase | Follow Up: Participants No Longer Treated for CPP (Female) | TEAE | 10 | Participants | |
| Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase | FollowUp:Treated With Non-Enantone GnRHa After Enantone-Female | TEAE | 9 | Participants | |
| Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase | Follow UP: Participants No Longer Treated for CPP (Male) | SAE | 0 | Participants | |
| Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase | Follow Up: Participants No Longer Treated for CPP (Female) | SAE | 0 | Participants | |
| Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase | FollowUp:Treated With Non-Enantone GnRHa After Enantone-Female | SAE | 0 | Participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Enantone Treatment Phase | STARTED | Treatment Phase: Enantone | 108 | |
| Enantone Treatment Phase | STARTED | Follow Up: Participants No Longer Treated for CPP | 0 | |
| Enantone Treatment Phase | STARTED | Follow Up: Treated With Non-Enantone GnRHa After Enantone | 0 | |
| Enantone Treatment Phase | COMPLETED | Treatment Phase: Enantone | 76 | |
| Enantone Treatment Phase | COMPLETED | Follow Up: Participants No Longer Treated for CPP | 0 | |
| Enantone Treatment Phase | COMPLETED | Follow Up: Treated With Non-Enantone GnRHa After Enantone | 0 | |
| Enantone Treatment Phase | NOT COMPLETED | Treatment Phase: Enantone | 32 | |
| Enantone Treatment Phase | NOT COMPLETED | Follow Up: Participants No Longer Treated for CPP | 0 | |
| Enantone Treatment Phase | NOT COMPLETED | Follow Up: Treated With Non-Enantone GnRHa After Enantone | 0 | |
| Follow-Up Phase | STARTED | Treatment Phase: Enantone | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events108
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | Treatment Phase: Enantone | 18 | 108 | |
| other | Upper respiratory tract infection | Infections and infestations | Follow Up: Participants No Longer Treated for CPP | 0 | 44 | |
| other | Upper respiratory tract infection | Infections and infestations | Follow Up: Treated With Non-Enantone GnRHa After Enantone | 1 | 26 | |
| other | Growth retardation | Musculoskeletal and connective tissue disorders | Treatment Phase: Enantone | 15 | 108 | |
| other | Growth retardation | Musculoskeletal and connective tissue disorders | Follow Up: Participants No Longer Treated for CPP | 0 | 44 | |
| other | Growth retardation | Musculoskeletal and connective tissue disorders | Follow Up: Treated With Non-Enantone GnRHa After Enantone | 2 | 26 | |
| other | Bronchitis | Infections and infestations | Treatment Phase: Enantone | 14 | 108 | |
| other | Bronchitis | Infections and infestations | Follow Up: Participants No Longer Treated for CPP | 0 | 44 | |
| other | Bronchitis | Infections and infestations | Follow Up: Treated With Non-Enantone GnRHa After Enantone | 0 | 26 | |
| other | Pharyngitis | Infections and infestations | Treatment Phase: Enantone | 13 | 108 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Phase: Enantone | 0 | 108 |
| Total, all-cause mortality | Follow Up: Participants No Longer Treated for CPP | 0 | 44 |
| Total, all-cause mortality | Follow Up: Treated With Non-Enantone GnRHa After Enantone | 0 | 26 |
| Total, other adverse events | Treatment Phase: Enantone | 63 | 108 |
| Total, other adverse events | Follow Up: Participants No Longer Treated for CPP | 0 | 44 |
| Total, other adverse events | Follow Up: Treated With Non-Enantone GnRHa After Enantone | 9 | 26 |
| Total, serious adverse events | Treatment Phase: Enantone | 2 | 108 |
| Total, serious adverse events | Follow Up: Participants No Longer Treated for CPP | 0 | 44 |
| Total, serious adverse events | Follow Up: Treated With Non-Enantone GnRHa After Enantone | 0 | 26 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02993926
GET https://conductscience.org/api/trials/v1/NCT02993926/results?page=2