Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study (DECAPUB)
This study has been completed.
Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00909844
First received: May 28, 2009
Last updated: February 29, 2016
Last verified: February 2016
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Purpose
The purpose of the protocol is to assess the efficacy of triptorelin 11.25 mg with respect to the proportion of children who maintain a regression or stabilisation of sexual maturity until the end of the study.
| Condition | Intervention | Phase |
|---|---|---|
|
Precocious Puberty |
Drug: Triptorelin (I.N.N.) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Follow-up of the Phase III, Multicentre, Non Comparative, One Single Group, Open Study to Assess the Long-term Efficacy and Tolerability of Pamoate of Triptorelin 11.25 mg in Children With Precocious Puberty |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial male-limited precocious puberty
MedlinePlus related topics:
Puberty
Drug Information available for:
Triptorelin pamoate
U.S. FDA Resources
Further study details as provided by Ipsen:
Primary Outcome Measures:
- Proportion of children with a stabilization or regression of Tanner pubertal stage at the end of the study, as compared to the stage at study entry (M6 of the phase III study 2-54-52014-143) [ Time Frame: M12, M24, M36, M48 and final visit (if applicable) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Luteinizing Hormone (LH) response to Gonadotropin-Releasing Hormone (GnRH) tests [ Time Frame: M12, M24, M36, M48 and final visit (if applicable) ] [ Designated as safety issue: No ]
- Levels of oestradiol in girls or testosterone in boys both measured by radioimmunoassay (RIA) [ Time Frame: M12, M24, M36, M48 and final visit (if applicable) ] [ Designated as safety issue: No ]
- Follicle Stimulating Hormone (FSH) response to GnRH test [ Time Frame: M12, M24, M36 M48 and final visit (if applicable) ] [ Designated as safety issue: No ]
- Body Mass Index (BMI) and BMI Standard Deviation (SD) score for the chronological age variation [ Time Frame: M12, M24, M36, M48 and final visit (if applicable) ] [ Designated as safety issue: No ]
- Auxological parameters variations (height, growth velocity, weight variation) [ Time Frame: M12, M24, M36, M48 and final visit (if applicable) ] [ Designated as safety issue: No ]
- Bone age variation [ Time Frame: M12, M24, M36, M48 and final visit (if applicable) ] [ Designated as safety issue: No ]
- Proportion of girls with an uterine length < 36 mm [ Time Frame: M12, M24, M36, M48 and final visit (if applicable) ] [ Designated as safety issue: No ]
| Enrollment: | 35 |
| Study Start Date: | April 2008 |
| Study Completion Date: | January 2016 |
| Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Triptorelin |
Drug: Triptorelin (I.N.N.)
Decapeptyl® SR 11.25mg
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- The child must have completed study 2-54-52014-143
- The child must have an effective response to 2 injections of triptorelin 11.25 mg according to investigator's evaluation with no significant treatment side effects
Exclusion Criteria:
- The patient has a known hypersensitivity to any of the test materials or related compounds
- The patient is unable or unwilling to comply fully with the protocol
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909844
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909844
Locations
| France | |
| Hôpital Hôtel Dieu (CHU) | |
| Angers, France, 49033 | |
| Medical Centre | |
| Bordeaux, France, 33000 | |
| Hôpital Flaubert | |
| Le Havre, France, 76083 | |
| Hôpital Archet II | |
| Nice, France, 06202 | |
| Hôpital Robert Debré | |
| Paris, France, 75019 | |
| American Memorial Hospital | |
| Reims, France, 51092 | |
| Hôpital Charles Nicolle | |
| Rouen, France, 76031 | |
| Hôpital Hautepierre | |
| Strasbourg, France, 67100 | |
| Hôpital de la Gespe | |
| Tarbes, France, 65013 | |
| Hôpital des Enfants | |
| Toulouse, France, 31026 | |
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Olivier GATTOLLIAT, MD | Ipsen |
More Information
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT00909844 History of Changes |
| Other Study ID Numbers: | 2-54-52014-159 2008-000565-39 |
| Study First Received: | May 28, 2009 |
| Last Updated: | February 29, 2016 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Puberty, Precocious Gonadal Disorders Endocrine System Diseases Triptorelin Pamoate Luteolytic Agents Contraceptive Agents, Female |
Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on September 23, 2016