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Generated: September 18, 2019

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CLINICAL TRIALS PROFILE FOR GONADORELIN HYDROCHLORIDE

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Clinical Trials for Gonadorelin Hydrochloride

Trial ID Title Status Sponsor Phase 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). Recruiting Barts & The London NHS Trust Phase 2/Phase 3 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 Recruiting Peking Union Medical College Hospital N/A 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 Recruiting Los Angeles Biomedical Research Institute Phase 1 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 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.
NCT04037254 Niraparib With Standard Combination Radiation Therapy and Androgen Deprivation Therapy in Treating Patients With High Risk Prostate Cancer Recruiting National Cancer Institute (NCI) Phase 2 This phase II trial studies the side effects and best dose of niraparib, and to see how well it works in combination with standard of care radiation therapy and hormonal therapy (androgen deprivation therapy) in treating patients with prostate cancer that has a high chance of coming back (high risk). Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding niraparib to the usual treatments of radiation therapy and hormonal therapy may lower the chance of prostate cancer growing or returning.
NCT04037254 Niraparib With Standard Combination Radiation Therapy and Androgen Deprivation Therapy in Treating Patients With High Risk Prostate Cancer Recruiting NRG Oncology Phase 2 This phase II trial studies the side effects and best dose of niraparib, and to see how well it works in combination with standard of care radiation therapy and hormonal therapy (androgen deprivation therapy) in treating patients with prostate cancer that has a high chance of coming back (high risk). Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding niraparib to the usual treatments of radiation therapy and hormonal therapy may lower the chance of prostate cancer growing or returning.
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Clinical Trial Conditions for Gonadorelin Hydrochloride

Condition Name

Condition Name for Gonadorelin Hydrochloride
Intervention Trials
Sleep Restriction 2
Stage IVA Prostate Cancer AJCC v8 1
Prostate Adenocarcinoma 1
Stage IIIC Prostate Cancer AJCC v8 1
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Condition MeSH

Condition MeSH for Gonadorelin Hydrochloride
Intervention Trials
Prostatic Neoplasms 2
Syndrome 1
Polycystic Ovary Syndrome 1
Infertility 1
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Clinical Trial Locations for Gonadorelin Hydrochloride

Trials by Country

Trials by Country for Gonadorelin Hydrochloride
Location Trials
United States 3
China 2
United Kingdom 1
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Trials by US State

Trials by US State for Gonadorelin Hydrochloride
Location Trials
California 2
Pennsylvania 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 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Gonadorelin Hydrochloride
Clinical Trial Phase Trials
Recruiting 5
Not yet recruiting 1
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Clinical Trial Sponsors for Gonadorelin Hydrochloride

Sponsor Name

Sponsor Name for Gonadorelin Hydrochloride
Sponsor Trials
Los Angeles Biomedical Research Institute 2
NRG Oncology 1
National Cancer Institute (NCI) 1
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Sponsor Type

Sponsor Type for Gonadorelin Hydrochloride
Sponsor Trials
Other 6
NIH 1
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