S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer
The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.
Study InterventionsTAK-700, BicalutamidePrimary EndpointsOverall SurvivalStudy Period2013-03-08 → 2025-09-09 PSA Levels and Biopsy Samples After Implant Radiation and Hormone Therapy in Patients With Stage I or Stage II Prostate Cancer
RATIONALE: Studying samples of blood and tissue from patients with prostate cancer after receiving implant radiation therapy and luteinizing hormone-releasing hormone agonist may help doctors identify biomarkers related to cancer and help doctors predict how patients will respond to treatment.
PURPOSE: This laboratory study is looking at PSA levels and biopsy samples after undergoing implant radi
Study InterventionsbiopsyPrimary EndpointsComparison of PSA levels and biopsy results at 36 months monthsStudy Period2011-04-01 → 2016-12-31 Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)
This multicenter, randomized, open-label exploratory study will be performed in approximately 200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro fertilization (IVF). Each study center will follow its standard practice for in vitro fertilization (IVF) within the study parameters as noted in this protocol. The study centers will use marketed products purchased fro
Study InterventionsMenotropin, Progesterone vaginal insert, Follitropin betaPrimary EndpointsParticipants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3Study Period2009-01 → 2010-09 A Study of the Effects of a Novel Ovarian Stimulation Regimen on Embryo Aneuploidy Rates in In Vitro Fertilization (IVF)
Background:
By limiting the number of embryos transferred to the uterus to only a single embryo, the risk of multiple gestation can be reduced. In order to improve the effectiveness of single embryo transfer, the ability to select the embryo with the highest potential to develop into a healthy child is of vital importance. While embryos rated as high quality by standardized morphological assessme
Study InterventionsOvarian stimulationPrimary EndpointsProportion of chromosomally abnormal and mosaic day 3 embryos per patient based on PGS analysis.Study Period2008-10 → 2011-01 Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone
During childhood, the levels of certain hormones: gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH), follicle-stimulating hormone (FSH), estrogen, and progesterone are very low. However, when puberty starts, GnRH and LH pulses begin to increase, but they initially do so at night only. It is unknown why GnRH and LH pulses increase at night and then decrease during the day (instead of
Study InterventionsProgesterone, PlaceboPrimary EndpointsAverage luteinizing hormone (LH) interpulse interval and the total number of LH pulsesStudy Period2011-03-11 → 2024-12 Comparative Study on the Efficacy of Ovarian Stimulation Protocols on the Success Rate of ICSI in Female Infertility
The study will describe the effectiveness of ovarian stimulation in correlation with female infertility causes in a Lebanese population: a comparative study using 5 protocols of ovulation induction (treatment with "A" gonadotropins alone, "B" short GnRH agonist, "C" multiple-dose GnRH antagonist, "D" long GnRH agonist and "E" combined protocol of GnRH antagonist and agonist) and the outcomes of IC
Study InterventionsHuman Chorionic Gonadotropin (hCG), Gonadotropins, GNRH-A TriptorelinPrimary EndpointsOvulation InductionStudy Period2018-02-01 → 2023-05-05 Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
The purpose of this survey is to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.
Study InterventionsLeuprorelin acetatePrimary EndpointsPercentage of Participants Who Had One or More Adverse EventsStudy Period2016-03-18 → 2018-10-10 Generation of Biological Samples Positive to Triptorelin for Anti-doping Control
Background:
Androgens are used for doping purpose because they can increase muscle mass and strength. These drugs are included in the list of prohibited substances of the World Anti-Doping Agency (WADA). The prohibition of its use has given rise to a great variety of strategies of indirect androgenic doping, whose purpose is to produce a sustained increase in endogenous testosterone.
Triptorelin
Study InterventionsTriptorelinPrimary EndpointsUrine concentration of triptorelin; Urine concentration of triptorelinStudy Period2019-04-26 → 2019-05-15 Induction and Maintenance of Castration After Subcutaneous Injections of Triptorelin Pamoate in Patients With Prostate Cancer
Assess the efficacy and safety of Triptorelin pamoate 3M formulation (11.25mg) when administered by subcutaneous route.
Study InterventionsTriptorelin Pamoate 11.25mgPrimary EndpointsPercentage of Subjects Demonstrating Castration at Day 29 and Maintaining Castration at Day 183Study Period2013-01 → 2013-10 Efficacy and Safety of Leuprorelin 3M in Premenopausal Women With Hormone Receptor-positive Breast Cancer
Leuprorelin, a LHRH agonist, acts as a potent inhibitor of gonadotropin secretion and is commonly used for the treatment of hormone-responsive prostate cancer, premenopausal HR+ breast cancer, endometriosis and uterine fibroids. It is currently available in 1M, 3M, 6M for subcutaneous administration. Initially administration would stimulate an increase in LH and FSH, causing a transient increase o
Study InterventionsAI or TAMPrimary Endpointsthe suppression proportion of serum estradiol (E2)Study Period2021-05 → 2023-09