Central Precocious PubertyNCT02993926

A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants

An observational study of Central Precocious Puberty, run by Takeda at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Central Precocious Puberty
What is being tested?: Enantone and GnRH agonist
Type of treatment: Injection or infusion
How many people: 108 participants
Where: 6 sitesChina
Study dates: 24 Jun 2017to 30 Sep 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Participants diagnosed with CPP will be observed.

Who may be able to join

Has diagnosis of idiopathic CPP.
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).
Has initiated and completed treatment during the index period from September 1st 1998 to September 30th 2018.
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.

Who cannot join

Has been treated with leuprorelin acetate or any other GnRHa for conditions other than CPP.
Has used any other GnRHa products for CPP treatment prior to initiation of enantone therapy.
CPP participants with identified etiology, such as brain tumor or cranial irradiation.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

China6 sites

Childrens Hospital of Hunan province
Changsha, Hunan, 410007
The Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310053
Children's Hospital of Jiangxi province
Nanchang, Jiangxi, 330006
Jiangsu Province Hosptial
Nanjing, Jiangsu, 210036
Children's Hospital of Shanghai
Shanghai, Shanghai Municipality, 200040
The Children's Hospital, Zhejiang University School of Medicine
Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: An Observational, Retrospective Study to Evaluate the Long Term Safety and Effectiveness of Leuprorelin in the Treatment of Central Precocious Puberty

The purpose of this study is to evaluate the long-term safety and efficacy of Enantone in the treatment of CPP in Chinese participants.

Read the 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.

Conditions: Central Precocious Puberty
Being tested: Enantone, GnRH agonist
Keywords: Drug Therapy
Medical subject headings: Puberty, Precocious

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EnantoneDrug
Also called Leuprorelin
Enantone suspension for injection
GnRH agonistDrug
A non-Enantone GnRH agonist

Study groups in NCT02993926
Study group	Role	What they receive
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). Receives: Drug: Enantone
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). Receives: Drug: GnRH agonist

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months
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.
Measured: 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 outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jun 201730 Sep 2018

First posted15 Dec 2016 (estimated)
Study start24 Jun 2017
Primary completion30 Sep 2018
Study completion30 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Central Precocious PubertyStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02993926
Sponsor's protocol ID: Leuprorelin-5001
Status last verified: Mar 2022
First submitted: 13 Dec 2016
Last updated: 16 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)
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RecruitingObservational study
Basal LH Threshold for the Diagnosis of Central Precocious Puberty
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INSL3 as a Biomarker of Pubertal Activation: Role in Evaluating Precocious and Delayed Puberty
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Active, not recruiting
Hypiend - Multicomponent Behavioral Intervention in Pre-puberal Children (Hypiend-PPC)
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RecruitingPhase 4
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All Central Precocious Puberty trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational, Retrospective Study to Evaluate the Long Term Safety and Effectiveness of Leuprorelin in the Treatment of Central Precocious Puberty
ClinicalTrials.gov ID: NCT02993926
Acronym / sponsor ID: Leuprorelin-5001
Conditions: Central Precocious Puberty
Keywords: Drug Therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 24 Jun 2017 (actual)
Primary completion: 30 Sep 2018 (actual)
Study completion: 30 Sep 2018 (actual)
First posted: 15 Dec 2016 (estimated)
Results: Posted 24 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 study will enroll approximately 300 participants.

This multi-center trial will be conducted in China. Data will be collected over period of 20 months.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 3

Arm	Type	Receives
Treatment Phase: Enantone	–	Drug: EnantoneParticipants 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	–	Drug: GnRH agonistParticipants 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).

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Participants diagnosed with CPP will be observed.

Key inclusion criteria (4 listed)

Has diagnosis of idiopathic CPP.
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).
Has initiated and completed treatment during the index period from September 1st 1998 to September 30th 2018.
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.

Key exclusion criteria (3 listed)

Has been treated with leuprorelin acetate or any other GnRHa for conditions other than CPP.
Has used any other GnRHa products for CPP treatment prior to initiation of enantone therapy.
CPP participants with identified etiology, such as brain tumor or cranial irradiation.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EnantoneAlso: LeuprorelinEnantone suspension for injection	Drug	Treatment Phase: Enantone
GnRH agonistA non-Enantone GnRH agonist	Drug	Follow Up: Treated with Non-Enantone GnRHa after Enantone

Primary outcome

Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase
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)
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
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)
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
Time frame: 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
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
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.

6 secondary outcomes

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
Time frame: 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
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
Percentage of Participants With Value, for Estradiol or Testosterone, Suppressed Below Upper Limit Value (ULV) at the End of Enantone Treatment Phase
Time frame: 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
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
Percentage of Participants With Decease of Ratio of Bone Age to Chronological Age at the End of Enantone Treatment Phase
Time frame: 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
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

Results and safety

Results posted to the registry on 24 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Phase: Enantone	108	76
Follow Up: Participants No Longer Treated for CPP	0	0
Follow Up: Treated With Non-Enantone GnRHa After Enantone	0	0

Primary outcome: Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase

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). Count of participants. Unit: Participants

Measure	Treatment Phase: Enantone (Male) n = 4	Treatment Phase: Enantone (Female) n = 104
TEAE	4	71
SAE	0	2

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

Primary outcome: Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase

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). Count of participants. Unit: Participants

Measure	Follow UP: Participants No Longer Treated for CPP (Male) n = 2	Follow Up: Participants No Longer Treated for CPP (Female) n = 42	FollowUp:Treated With Non-Enantone GnRHa After Enantone-Female n = 26
TEAE	0	10	9
SAE	0	0	0

Population analysed: 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.

Primary outcome: Percentage of Participants Who Had Regression or No Progression in Tanner Staging at the End of Enantone Treatment Phase

Time frame: The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Treatment Phase: Enantone (Male) n = 1	Treatment Phase: Enantone (Female) n = 79
Value	0 (0 to 97.50)	79.7 (69.20 to 87.96)

Population analysed: 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.

Primary outcome: Percentage of Participants Who Had Regression or No Progression in Tanner Staging at the End of Follow-Up Phase

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. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Follow UP: Participants No Longer Treated for CPP (Male) n = 0	Follow Up: Participants No Longer Treated for CPP (Female) n = 0	FollowUp:Treated With Non-Enantone GnRHa After Enantone-Female n = 1
Value	–	–	0 (0 to 97.5)

Population analysed: 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.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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 reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Phase: Enantone	2 of 108 (1.9%)	63 of 108 (58.3%)	0 of 108
Follow Up: Participants No Longer Treated for CPP	0 of 44 (0%)	0 of 44 (0%)	0 of 44
Follow Up: Treated With Non-Enantone GnRHa After Enantone	0 of 26 (0%)	9 of 26 (34.6%)	0 of 26

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director Clinical Science study director

Takeda

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Central Precocious Puberty, run by Takeda at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase (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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02993926.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.