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Trelstar Depot (Triptorelin Pamoate) - Summary

 
 



TRELSTAR DEPOT SUMMARY

B1
Revised: September 2005
Watson Pharma, Inc.
TRELSTAR® DEPOT 3.75 mg
(triptorelin pamoate for injectable suspension)

TRELSTAR DEPOT contains a pamoate salt of triptorelin, and triptorelin is a synthetic decapeptide agonist analog of luteinizing hormone releasing hormone (LHRH or GnRH) with greater potency than the naturally occurring LHRH.

TRELSTAR DEPOT is indicated in the palliative treatment of advanced prostate cancer. It offers an alternative treatment for prostate cancer when orchiectomy or estrogen administration are either not indicated or unacceptable to the patient.


See all Trelstar Depot indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Trelstar Depot (Triptorelin)

Early onset prostate cancer a newly identified, more aggressive subtype often linked to genetic mutations
Source: Genetics News From Medical News Today [2014.07.18]
The number of younger men diagnosed with prostate cancer has increased nearly 6-fold in the last 20 years, and the disease is more likely to be aggressive in these younger men, according to a new...

Urologist Most Influential in Prostate Cancer Tx Decisions
Source: Medscape Hematology-Oncology Headlines [2014.07.16]
Rates for observation and active treatment vary widely, but patients who received a diagnosis from urologists who treat low-risk prostate cancer were more like to receive up-front treatment.
Medscape Medical News

Prostate cancer is focus of two studies in JAMA Internal Medicine
Source: Medicare / Medicaid / SCHIP News From Medical News Today [2014.07.16]
Management for Low-Risk Prostate Cancer Varies Widely Among Physicians Management of low-risk prostate cancer (which is unlikely to cause symptoms or affect survival if left untreated) varies...

Hot Topics 2014: Prostate Cancer Revisited
Source: MedPage Today Oncology/Hematology [2014.07.16]
(MedPage Today) -- Early this year we asked, "What will be the most important clinical development in prostate cancer in 2014?" Now, at the half-year mark, we ask Derek Raghavan, MD, PhD, of Carolinas HealthCare's Levine Cancer Institute in Charlotte, N.C., and Peter Scardino, MD, of Memorial Sloan Kettering Cancer Center in New York City, how their predictions are holding up.

Men With Prostate Cancer May Not Always Get Best Advice
Source: MedicineNet Mens Health Specialty [2014.07.15]
Title: Men With Prostate Cancer May Not Always Get Best Advice
Category: Health News
Created: 7/14/2014 4:36:00 PM
Last Editorial Review: 7/15/2014 12:00:00 AM

more news >>

Published Studies Related to Trelstar Depot (Triptorelin)

Effect of the gonadotropin-releasing hormone analogue triptorelin on the occurrence of chemotherapy-induced early menopause in premenopausal women with breast cancer: a randomized trial. [2011.07.20]
CONTEXT: Premenopausal patients with breast cancer are at high risk of premature ovarian failure induced by systemic treatments, but no standard strategies for preventing this adverse effect are yet available. OBJECTIVE: To determine the effect of the temporary ovarian suppression obtained by administering the gonadotropin-releasing hormone analogue triptorelin during chemotherapy on the incidence of early menopause in young patients with breast cancer undergoing adjuvant or neoadjuvant chemotherapy... CONCLUSION: The use of triptorelin-induced temporary ovarian suppression during chemotherapy in premenopausal patients with early-stage breast cancer reduced the occurrence of chemotherapy-induced early menopause. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00311636.

A comparison of the effect of short-term aromatase inhibitor (letrozole) and GnRH agonist (triptorelin) versus case control on pregnancy rate and symptom and sign recurrence after laparoscopic treatment of endometriosis. [2011.07]
PURPOSE: To compare the role of an aromatase inhibitor (letrozole) with a GnRH agonist (triptorelin) versus case control on the pregnancy rate and recurrence of symptoms and signs in patients with endometriosis... CONCLUSION: Pregnancy rate and endometriosis recurrence rate are comparable among the 3 groups.

Synchronization of ovulation and fertility in weaned sows treated with intravaginal triptorelin is influenced by timing of administration and follicle size. [2011.01.15]
A 100 mug dose of triptorelin was tested for synchronizing ovulation in sows. In Experiment 1, conducted in April through June, sows (n = 125) were assigned to Control (untreated), TG-96 (Triptorelin Gel (TG) given intravaginally at 96 h post-weaning), or TG-E (given intravaginally at estrus)... However, ovulation induction and timed AI success may benefit from an approach that ensures sows have adequate follicle development at time of treatment.

A randomized, controlled clinical trial comparing the effects of aromatase inhibitor (letrozole) and gonadotropin-releasing hormone agonist (triptorelin) on uterine leiomyoma volume and hormonal status. [2010.01]
OBJECTIVE: To examine and compare the efficacy and safety of GnRH agonist (GnRHa) vs. aromatase inhibitor in premenopausal women with leiomyomas.

A randomized, controlled clinical trial comparing the effects of aromatase inhibitor (letrozole) and gonadotropin-releasing hormone agonist (triptorelin) on uterine leiomyoma volume and hormonal status. [2009.01.08]
OBJECTIVE: To examine and compare the efficacy and safety of GnRH agonist (GnRHa) vs. aromatase inhibitor in premenopausal women with leiomyomas.Rapid onset of action and avoidance of initial gonadotropin flare with an aromatase inhibitor may be advantageous for short-term management of women with myomas of any size who are to be managed transiently and who wish to avoid surgical intervention, specifically women with unexplained infertility having uterine myoma.

more studies >>

Clinical Trials Related to Trelstar Depot (Triptorelin)

Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg [Recruiting]
The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11. 25 mg), applied either IM or SC, in terms of the area under the curve [AUC1-85day] for serum testosterone in patients with advanced prostate cancer.

Study to Assess the Non-Inferiority of Pamorelin® 11,25mg SC Injected Versus Pamorelin® 11,25mg IM Injected in Patients Suffering From Advanced Prostate Cancer (PAMOJECT) [Recruiting]
The active ingredient of Pamorelin® 11,25 mg is Triptorelin. Triptorelin is a substitute for a natural hormone produced in the body called Gonadotrophin-releasing hormone (GnRH). GnRH is a hormone secreted by hypothalamus (a gland located in brain) and controls the production of sex hormones (eg testosterone in men) in other organs in the body. The growth of prostate cancer cells, one of the most common cancers in men, is induced by the hormone testosterone. Hormono-therapy is one of treatments available to treat this type of disease by controlling the testosterone serum level. Pamorelin® 11,25 mg is normally injected in the muscle but this type of injection is not suitable for every patient. Therefore the primary purpose of this study is to assess the non-inferiority of the 12-week triptorelin formulation Pamorelin® 11,25 mg administered via subcutaneous (SC) injection as compared to Pamorelin® 11,25 mg administered via standard intramuscular (IM) injection based on the percentage of patients presenting a testosterone level ≤ 50 ng/dl at week 24.

Efficacy, Safety, and PK of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty [Recruiting]
The study will investigate the efficacy, safety and pharmacokinetics of triptorelin 22. 5 mg 6-month formulation in 44 patients suffering from central precocious puberty. The null hypothesis of the study is that the proportion of patients achieving LH suppression to prepubertal levels at Month 6 is 80%.

HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer. [Recruiting]
The HOBOE study was amended in November 2009, and, after reaching enrollment of the first 500 patients, the study began recruiting premenopausal patients only. The primary objective of the extended study is to compare disease free survival in premenopausal patients with early breast cancer. Patients receive triptorelin and are randomized in a 1: 1:1 fashion to receive tamoxifen or letrozole, or letrozole + zoledronic acid.

The purpose of the HOBOE study, Version 1, was to compare the adjuvant hormonal therapy treatments of Tamoxifen, Letrozole and Letrozole + Zoledronate for their effects on bone loss in breast cancer patients. Postmenopausal and premenopausal patients were eligible, the latter also receiving monthly triptorelin. Upon reaching the enrollment of the first 500 patients in March 2010, the study began recruiting premenopausal patients only.

Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer [Recruiting]
The study will investigate the efficacy, pharmacokinetics and safety of triptorelin embonate 22. 5 mg 6-month formulation administered by subcutaneous injections in patients with prostate cancer

more trials >>


Page last updated: 2014-07-18

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