Trial · NCT00779103
Histrelin Subcutaneous Implant in Children With Central Precocious Puberty
NCT00779103, Phase 3, Completed, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2021-01-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Histrelin Subcutaneous Implant in Children With Central Precocious Puberty. Trials, record NCT00779103. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00779103
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Histrelin Subcutaneous Implant in Children With Central Precocious Puberty
- NCT number
- NCT00779103
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 36 participants, actual
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Conditions
- Central Precocious Puberty
- Interventions
- Histrelin Subcutaneous Implant
- First posted
- 2008-10-24
- Last updated
- 2021-01-08
- Results first posted
- 2021-01-08
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Luteinizing Hormone (LH) | Baseline - 6 Months Post Last Implant | The suppression of gonadotropins (luteinizing hormone and follicle stimulating hormone) and gonadal sex steroids (estrogen in girls and testosterone in boys, respectively) on treatment.(LH suppression is defined as a peak LH \< 4 mIU/mL following stimulation with the GnRH analog). |
| Secondary | Follicle Stimulating Hormone (FSH) | Baseline - 6 Month Post Last Implant | The suppression of gonadotropins (luteinizing hormone and follicle stimulating hormone) and gonadal sex steroids (estrogen in girls and testosterone in boys, respectively) on treatment.(LH suppression is defined as a peak LH \< 4 mIU/mL following stimulation with the GnRH analog). |
| Secondary | Testosterone | Baseline - 12 Months Post Last Implant | Long-term treatment with histrelin acetate suppresses the LH response to GnRH causing LH levels to decrease to prepubertal levels within 1 month of treatment. As a result, serum concentrations of sex steroids (estrogen or testosterone) also decrease. Testosterone suppression is defined as serum testosterone \< 30.0 ng/dL (0.8 nmol/L) in boys following the induction of suppression. One black female participant age 8.9 years old had a testosterone value of 11ng/dL at visit 4 (month 6). |
| Secondary | DHEA Sulfate | Baseline - 36 Months Post Last Implant | DHEA=Dehydroepiandrosterone |
| Secondary | Estradiol (MS) | Month 36 - 36 Months Post Last Implant | Long-term treatment with histrelin acetate suppresses the LH response to GnRH causing LH levels to decrease to prepubertal levels within 1 month of treatment. As a result, serum concentrations of sex steroids (estrogen or testosterone) also decrease. Estradiol suppression is defined as serum estradiol in the assay specific range \< 20 pg/mL (73 pmol/L) in girls following the induction of suppression. |
| Secondary | Estradiol (RIA) | Baseline - Month 24 | Long-term treatment with histrelin acetate suppresses the LH response to GnRH causing LH levels to decrease to prepubertal levels within 1 month of treatment. As a result, serum concentrations of sex steroids (estrogen or testosterone) also decrease. Estradiol suppression is defined as serum estradiol in the assay specific range \< 20 pg/mL (73 pmol/L) in girls following the induction of suppression. |
| Secondary | Average Number of Implants Received | 12 months | There were 2 implants received that were not removed during the study and were excluded from this analysis due to unknown duration of treatment. |
| Secondary | Average Mean Implant Duration by Subject | 12 Months | There were 2 implants received that were not removed during the study and were excluded from this analysis due to unknown duration of treatment. |
| Secondary | Summary of EN3326 Implantation and Explantations | Day 1 - Month 60 | Once the female participants reached 11 years of age and the male participants reached 12 years of age or the investigator determined that subjects no longer required hormone suppression, participants underwent final explantation and were eligible to continue into an optional Long Term Follow Up Phase (Post Implant Treatment Phase) for up to 5 years. The purpose of the optional Long Term Follow Up Phase was to collect additional medical and developmental information, such as onset of menses and final adult height after hormone suppression was discontinued. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Luteinizing Hormone (LH) | Baseline - 6 Months Post Last Implant | Extension Safety Population | MIU/ML | MEAN |
| SECONDARY | Follicle Stimulating Hormone (FSH) | Baseline - 6 Month Post Last Implant | Extension Safety Population | MIU/ML | MEAN |
| SECONDARY | Testosterone | Baseline - 12 Months Post Last Implant | Extension Safety Population | NG/DL | MEAN |
| SECONDARY | DHEA Sulfate | Baseline - 36 Months Post Last Implant | Extension Safety Population | UG/DL | MEAN |
| SECONDARY | Estradiol (MS) | Month 36 - 36 Months Post Last Implant | Extension Safety Population | NG/DL | MEAN |
| SECONDARY | Estradiol (RIA) | Baseline - Month 24 | Extension Safety Population | NG/DL | MEAN |
| SECONDARY | Average Number of Implants Received | 12 months | Extension Safety Population | Implants | MEAN |
| SECONDARY | Average Mean Implant Duration by Subject | 12 Months | Extension Safety Population | Months | MEAN |
| SECONDARY | Summary of EN3326 Implantation and Explantations | Day 1 - Month 60 | Extension Safety Population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group186
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Luteinizing Hormone (LH) | Observed Value | Baseline | 0.88 | Standard Deviation 1.244 | MIU/ML |
| Luteinizing Hormone (LH) | Observed Value | Day 1, Visit 1 | 0.53 | MIU/ML | |
| Luteinizing Hormone (LH) | Change From Baseline | Day 1, Visit 1 | 0.07 | MIU/ML | |
| Luteinizing Hormone (LH) | Observed Value | Month 1, Visit 2 | 0.50 | Standard Deviation 0.302 | MIU/ML |
| Luteinizing Hormone (LH) | Change From Baseline | Month 1, Visit 2 | -0.37 | Standard Deviation 1.111 | MIU/ML |
| Luteinizing Hormone (LH) | Observed Value | Month 3, Visit 3 | 0.39 | Standard Deviation 0.247 | MIU/ML |
| Luteinizing Hormone (LH) | Change From Baseline | Month 3, Visit 3 | -0.50 | Standard Deviation 1.173 | MIU/ML |
| Luteinizing Hormone (LH) | Observed Value | Month 6, Visit 4 | 0.37 | Standard Deviation 0.225 | MIU/ML |
| Luteinizing Hormone (LH) | Change From Baseline | Month 6, Visit 4 | -0.53 | Standard Deviation 1.227 | MIU/ML |
| Luteinizing Hormone (LH) | Observed Value | Month 9, Visit 5 | 0.38 | Standard Deviation 0.266 | MIU/ML |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Overall - Histrelin Subcutaneous Implant (50 mg) | 36 | |
| Overall Study | Second & Third Implant | Overall - Histrelin Subcutaneous Implant (50 mg) | 31 | |
| Overall Study | Fourth Implant | Overall - Histrelin Subcutaneous Implant (50 mg) | 13 | |
| Overall Study | No Treatment | Overall - Histrelin Subcutaneous Implant (50 mg) | 9 | |
| Overall Study | COMPLETED | Overall - Histrelin Subcutaneous Implant (50 mg) | 36 | |
| Overall Study | NOT COMPLETED | Overall - Histrelin Subcutaneous Implant (50 mg) | 0 |
Source ClinicalTrials.gov
Adverse events14
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 | Implant Site Reaction | General disorders | Overall - Histrelin Subcutaneous Implant (50 mg) | 20 | 31 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Overall - Histrelin Subcutaneous Implant (50 mg) | 8 | 31 | |
| other | Nasopharyngitis | Infections and infestations | Overall - Histrelin Subcutaneous Implant (50 mg) | 6 | 31 | |
| other | Pharyngitis Streptococcal | Infections and infestations | Overall - Histrelin Subcutaneous Implant (50 mg) | 5 | 31 | |
| other | Sinusitis | Infections and infestations | Overall - Histrelin Subcutaneous Implant (50 mg) | 4 | 31 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Overall - Histrelin Subcutaneous Implant (50 mg) | 4 | 31 | |
| other | Headache | Nervous system disorders | Overall - Histrelin Subcutaneous Implant (50 mg) | 6 | 31 | |
| other | Weight Increased | Investigations | Overall - Histrelin Subcutaneous Implant (50 mg) | 4 | 31 | |
| other | Agression | Psychiatric disorders | Overall - Histrelin Subcutaneous Implant (50 mg) | 3 | 31 | |
| other | Depression | Psychiatric disorders | Overall - Histrelin Subcutaneous Implant (50 mg) | 2 | 31 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Overall - Histrelin Subcutaneous Implant (50 mg) | 1 | 31 |
| Total, other adverse events | Overall - Histrelin Subcutaneous Implant (50 mg) | 31 | 31 |
| Total, serious adverse events | Overall - Histrelin Subcutaneous Implant (50 mg) | 3 | 31 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00779103
GET https://conductscience.org/api/trials/v1/NCT00779103/results?page=2