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Last Updated: July 3, 2022

CLINICAL TRIALS PROFILE FOR GONADORELIN HYDROCHLORIDE


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All Clinical Trials for Gonadorelin Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01907009 ↗ A PHASEII STUDY EVALUATING INTRAVENOUS MELPHALAN WITH AUTOLOGOUS WHOLE BLOOD STEM CELL TRANSPLANTATION (PBSCT)OVER THREE CYCLES IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER (MEL-CAP). Unknown status Barts & The London NHS Trust Phase 2/Phase 3 2013-01-01 The management of (castration-resistant) prostate cancer (CRPC) is becoming increasingly complex. The use of peripheral anti-androgens with gonadorelin analogues (maximum androgen blockade) is common place. Following the failure of such an approach, several strategies may be employed. Both corticosteroids and estrogens have a role and increasingly chemotherapy is being used. The demonstration of enhanced survival using 3 weekly docetaxel has meant that this is viewed by many as the standard of care for fit patients. Melphalan is an established alkylating drug that has demonstrated some activity in CRPC, but to date, myelosuppression has prevented adequate dosing. We have recently conducted a phase I dose escalation study using melphalan and whole blood stem cell re-infusion and it shows that median overall survival is 22 months, which is higher than the median survival rate of 19 months for Docetaxel Data from a previous phase I study has proved the successful administration of higher doses of IV Melphalan in combination with autologous blood infusion in patients with Castration-resistant prostate cancer. Rapid falls in circulating tumour cells were seen within 2 weeks of starting Melphalan, however slow platelet recovery meant longer periods of platelet transfusion. For this study we intend to assess the efficacy of an intensified intravenous melphalan with autologous whole blood stem cell transplantation over three treatment cycles. 39 patients will be enrolled over a 3 year period and at least 17 patients need to survive progression free at least 6-months for this study to be considered positive. Mel-CAP is a combination chemotherapy consisting of two chemotherapy drugs: MELPHALAN and LENOGRASTIM for 3 cycles alternately.
NCT02349347 ↗ A PHASEII STUDY EVALUATING INTRAVENOUS MELPHALAN WITH AUTOLOGOUS WHOLE BLOOD STEM CELL TRANSPLANTATION (PBSCT)OVER THREE CYCLES IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER (MEL-CAP). Unknown status Barts & The London NHS Trust Phase 2/Phase 3 2013-01-01 The management of (castration-resistant) prostate cancer (CRPC) is becoming increasingly complex. The use of peripheral anti-androgens with gonadorelin analogues (maximum androgen blockade) is common place. Following the failure of such an approach, several strategies may be employed. Both corticosteroids and estrogens have a role and increasingly chemotherapy is being used. The demonstration of enhanced survival using 3 weekly docetaxel has meant that this is viewed by many as the standard of care for fit patients. Melphalan is an established alkylating drug that has demonstrated some activity in CRPC, but to date, myelosuppression has prevented adequate dosing. We have recently conducted a phase I dose escalation study using melphalan and whole blood stem cell re-infusion and it shows that median overall survival is 22 months, which is higher than the median survival rate of 19 months for Docetaxel Data from a previous phase I study has proved the successful administration of higher doses of IV Melphalan in combination with autologous blood infusion in patients with Castration-resistant prostate cancer. Rapid falls in circulating tumour cells were seen within 2 weeks of starting Melphalan, however slow platelet recovery meant longer periods of platelet transfusion. For this study we intend to assess the efficacy of an intensified intravenous melphalan with autologous whole blood stem cell transplantation over three treatment cycles. 39 patients will be enrolled over a 3 year period and at least 17 patients need to survive progression free at least 6-months for this study to be considered positive. Mel-CAP is a combination chemotherapy consisting of two chemotherapy drugs: MELPHALAN and LENOGRASTIM for 3 cycles alternately.
NCT02349347 ↗ A PHASEII STUDY EVALUATING INTRAVENOUS MELPHALAN WITH AUTOLOGOUS WHOLE BLOOD STEM CELL TRANSPLANTATION (PBSCT)OVER THREE CYCLES IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER (MEL-CAP). Unknown status Queen Mary University of London Phase 2/Phase 3 2013-01-01 The management of (castration-resistant) prostate cancer (CRPC) is becoming increasingly complex. The use of peripheral anti-androgens with gonadorelin analogues (maximum androgen blockade) is common place. Following the failure of such an approach, several strategies may be employed. Both corticosteroids and estrogens have a role and increasingly chemotherapy is being used. The demonstration of enhanced survival using 3 weekly docetaxel has meant that this is viewed by many as the standard of care for fit patients. Melphalan is an established alkylating drug that has demonstrated some activity in CRPC, but to date, myelosuppression has prevented adequate dosing. We have recently conducted a phase I dose escalation study using melphalan and whole blood stem cell re-infusion and it shows that median overall survival is 22 months, which is higher than the median survival rate of 19 months for Docetaxel Data from a previous phase I study has proved the successful administration of higher doses of IV Melphalan in combination with autologous blood infusion in patients with Castration-resistant prostate cancer. Rapid falls in circulating tumour cells were seen within 2 weeks of starting Melphalan, however slow platelet recovery meant longer periods of platelet transfusion. For this study we intend to assess the efficacy of an intensified intravenous melphalan with autologous whole blood stem cell transplantation over three treatment cycles. 39 patients will be enrolled over a 3 year period and at least 17 patients need to survive progression free at least 6-months for this study to be considered positive. Mel-CAP is a combination chemotherapy consisting of two chemotherapy drugs: MELPHALAN and LENOGRASTIM for 3 cycles alternately.
NCT02705014 ↗ Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome Unknown status Peking Union Medical College Hospital N/A 2016-01-01 To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy.
NCT03142893 ↗ Hormonal Mechanisms of Sleep Restriction - Axis Study Active, not recruiting Los Angeles Biomedical Research Institute Phase 1 2017-05-08 The purpose of this study is to 1) determine how hypothalamic-pituitary-adrenal axis (HPA axis) activation occurs with sleep restriction 2) evaluate how hypothalamic-pituitary-gonadal axis (HPG axis) deactivation occurs with sleep restriction. The investigator will also examine the cognitive function associated with sleep restriction, including food intake and food cravings.
NCT03142893 ↗ Hormonal Mechanisms of Sleep Restriction - Axis Study Active, not recruiting Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Phase 1 2017-05-08 The purpose of this study is to 1) determine how hypothalamic-pituitary-adrenal axis (HPA axis) activation occurs with sleep restriction 2) evaluate how hypothalamic-pituitary-gonadal axis (HPG axis) deactivation occurs with sleep restriction. The investigator will also examine the cognitive function associated with sleep restriction, including food intake and food cravings.
NCT03989024 ↗ Pulsatile Gonadotropin-releasing Hormone for Infertility in Non-obese Patients With Polycystic Ovary Syndrome Not yet recruiting RenJi Hospital Phase 4 2019-07-01 Polycystic ovary syndrome (PCOS) patients are often accompanied by infertility. Non-obese PCOS infertility is more difficult to treat than obese PCOS. The study included non-obese PCOS patients who had not recovered from regular menstruation after six months of metformin treatment. Half of the patients were treated with clomiphene for ovulation induction and half with GnRH pulse therapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Gonadorelin Hydrochloride

Condition Name

Condition Name for Gonadorelin Hydrochloride
Intervention Trials
Castrate Resistant Prostate Cancer 2
Hypogonadotropic Hypogonadism 2
Sleep Restriction 2
Stage III Prostate Cancer AJCC v8 1
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Condition MeSH

Condition MeSH for Gonadorelin Hydrochloride
Intervention Trials
Prostatic Neoplasms 3
Hypogonadism 2
Adenocarcinoma 1
Syndrome 1
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Clinical Trial Locations for Gonadorelin Hydrochloride

Trials by Country

Trials by Country for Gonadorelin Hydrochloride
Location Trials
United States 22
China 3
United Kingdom 2
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Trials by US State

Trials by US State for Gonadorelin Hydrochloride
Location Trials
California 3
Ohio 1
Maryland 1
Michigan 1
Mississippi 1
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Clinical Trial Progress for Gonadorelin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Gonadorelin Hydrochloride
Clinical Trial Phase Trials
Phase 4 1
Phase 2/Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Gonadorelin Hydrochloride
Clinical Trial Phase Trials
Unknown status 3
Recruiting 2
Active, not recruiting 2
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Clinical Trial Sponsors for Gonadorelin Hydrochloride

Sponsor Name

Sponsor Name for Gonadorelin Hydrochloride
Sponsor Trials
Barts & The London NHS Trust 2
Los Angeles Biomedical Research Institute 2
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center 2
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Sponsor Type

Sponsor Type for Gonadorelin Hydrochloride
Sponsor Trials
Other 11
NIH 1
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