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Last Updated: December 3, 2022

CLINICAL TRIALS PROFILE FOR TRIPTORELIN PAMOATE


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All Clinical Trials for Triptorelin Pamoate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00124514 ↗ Triptorelin for Ovary Protection in Childhood Onset Lupus Completed Watson Pharmaceuticals Phase 2 2003-06-01 The purpose of this study is to test the safety of triptorelin when used for the protection of the ovaries (pair of female reproductive organs) during cyclophosphamide therapy for systemic lupus erythematosus (SLE; lupus) and to see what effects (good or bad) it has on patients. The study will be done with female patients who have been diagnosed with systemic lupus erythematosus, are younger than 21 years of age, and require intravenous cyclophosphamide to control the disease. Each patient will be in the study for approximately 23 months, until 4 months after the intravenous cyclophosphamide treatment has been completed. This study is currently being conducted at 3 sites across the United States and Brazil (Los Angeles, Cincinnati and San Paulo Brazil). A total of 50 patients will participate in this study. Each patient will be randomized (assigned) to one of 5 groups. Randomization means that patients are put into a group completely by chance. It is like flipping a coin. Neither the patient nor the study staff knows what group the patient is in. The patient has a 20% chance of being placed in any group. This is a dose escalation study, each patient will receive the first dose of the study drug (T1 - T4, placebo). If a patient has complete ovarian suppression on day 27 after the initial injection of study drug, then she will remain on this weight-adjusted dose of study drug throughout the study. The dose will be increased up for a weight gain of 5kg or greater. The dose will not be adjusted downward for a weight loss. If COS was not maintained with the 1st dose of study drug, then the subsequently injected 2nd dose will be increased by 25% or at least 20 microgram/kg/dose. The maximal dose of 150 microgram/kg/dose will not be exceeded. The absolute maximum dose is 20 mg. Funding Source: FDA OOPD and Watson Pharmaceuticals
NCT00124514 ↗ Triptorelin for Ovary Protection in Childhood Onset Lupus Completed Children's Hospital Medical Center, Cincinnati Phase 2 2003-06-01 The purpose of this study is to test the safety of triptorelin when used for the protection of the ovaries (pair of female reproductive organs) during cyclophosphamide therapy for systemic lupus erythematosus (SLE; lupus) and to see what effects (good or bad) it has on patients. The study will be done with female patients who have been diagnosed with systemic lupus erythematosus, are younger than 21 years of age, and require intravenous cyclophosphamide to control the disease. Each patient will be in the study for approximately 23 months, until 4 months after the intravenous cyclophosphamide treatment has been completed. This study is currently being conducted at 3 sites across the United States and Brazil (Los Angeles, Cincinnati and San Paulo Brazil). A total of 50 patients will participate in this study. Each patient will be randomized (assigned) to one of 5 groups. Randomization means that patients are put into a group completely by chance. It is like flipping a coin. Neither the patient nor the study staff knows what group the patient is in. The patient has a 20% chance of being placed in any group. This is a dose escalation study, each patient will receive the first dose of the study drug (T1 - T4, placebo). If a patient has complete ovarian suppression on day 27 after the initial injection of study drug, then she will remain on this weight-adjusted dose of study drug throughout the study. The dose will be increased up for a weight gain of 5kg or greater. The dose will not be adjusted downward for a weight loss. If COS was not maintained with the 1st dose of study drug, then the subsequently injected 2nd dose will be increased by 25% or at least 20 microgram/kg/dose. The maximal dose of 150 microgram/kg/dose will not be exceeded. The absolute maximum dose is 20 mg. Funding Source: FDA OOPD and Watson Pharmaceuticals
NCT00194792 ↗ Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer Terminated National Cancer Institute (NCI) Phase 2 2005-08-01 This phase II trial is studying how well giving hormone therapy together with combination chemotherapy before and after surgery works in treating patients with stage I-IIIA breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane and triptorelin pamoate may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy, such as capecitabine, methotrexate, vinorelbine ditartrate, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery
NCT00194792 ↗ Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer Terminated University of Washington Phase 2 2005-08-01 This phase II trial is studying how well giving hormone therapy together with combination chemotherapy before and after surgery works in treating patients with stage I-IIIA breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane and triptorelin pamoate may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy, such as capecitabine, methotrexate, vinorelbine ditartrate, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery
NCT00564850 ↗ Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty Completed Ipsen Phase 3 2007-10-01 The purpose of the study is to assess the efficacy of triptorelin 11.25 mg pamoate in the delay of premature onset of puberty in girls less than 9 years and boys less than 10 years. This is measured by assessing the proportion of children who have a suppressed Luteinizing Hormone (LH) response to Gonadotropin Releasing Hormone (GnRH) test performed 3 months after injection with triptorelin 11.25 mg.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Triptorelin Pamoate

Condition Name

Condition Name for Triptorelin Pamoate
Intervention Trials
Prostate Cancer 5
Central Precocious Puberty 3
Precocious Puberty 2
Prostate Adenocarcinoma 2
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Condition MeSH

Condition MeSH for Triptorelin Pamoate
Intervention Trials
Prostatic Neoplasms 7
Puberty, Precocious 5
Adenocarcinoma 2
Breast Neoplasms 1
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Clinical Trial Locations for Triptorelin Pamoate

Trials by Country

Trials by Country for Triptorelin Pamoate
Location Trials
United States 42
France 3
China 2
Israel 1
Bulgaria 1
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Trials by US State

Trials by US State for Triptorelin Pamoate
Location Trials
California 5
New Jersey 4
New York 4
Florida 3
Washington 3
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Clinical Trial Progress for Triptorelin Pamoate

Clinical Trial Phase

Clinical Trial Phase for Triptorelin Pamoate
Clinical Trial Phase Trials
Phase 4 2
Phase 3 7
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for Triptorelin Pamoate
Clinical Trial Phase Trials
Completed 8
Terminated 3
Active, not recruiting 1
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Clinical Trial Sponsors for Triptorelin Pamoate

Sponsor Name

Sponsor Name for Triptorelin Pamoate
Sponsor Trials
Ipsen 7
Watson Pharmaceuticals 3
National Cancer Institute (NCI) 3
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Sponsor Type

Sponsor Type for Triptorelin Pamoate
Sponsor Trials
Industry 13
Other 7
NIH 3
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