CLINICAL TRIALS PROFILE FOR LEUPROLIDE ACETATE FOR DEPOT SUSPENSION
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All Clinical Trials for LEUPROLIDE ACETATE FOR DEPOT SUSPENSION
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00598312 ↗ | Safety and Efficacy Study of Leuprolide Acetate for Injectable Suspension 22.5 MG in the Treatment of Prostate Cancer | Completed | Oakwood Laboratories, LLC | Phase 3 | 2007-04-01 | The purpose of the study is to demonstrate the safety and efficacy of Leuprolide Acetate for Injectable Suspension 22.5 mg in reducing serum testosterone to castrate levels in patients with prostate cancer. |
| NCT00621179 ↗ | Endometrial Markers and Response of Endometriosis Patients to Prolonged GnRH Agonist Prior to IVF | Completed | Colorado Center for Reproductive Medicine | Phase 4 | 2003-03-01 | This prospective randomized trial evaluates whether one can predict which infertile women with endometriosis who are candidates for in vitro fertilization will benefit from prolonged therapy with a GnRH agonist by the determination of the absence of endometrial expression of the integrin, alpha v, beta 3 vitronectin. This is a prospective randomized trial in which all patients will undergo endometrial biopsy prior to initiation of ovarian stimulation for in vitro fertilization and then undergo randomization to a three month course of a depot preparation of the GnRH agonist leuprolide acetate in depot suspension prior to ovarian stimulation or standard therapy. prio |
| NCT01069094 ↗ | A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata | Completed | Repros Therapeutics Inc. | Phase 1/Phase 2 | 2004-07-01 | A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata. |
| NCT02452931 ↗ | Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty | Completed | Tolmar Inc. | Phase 3 | 2015-08-31 | This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty. |
| NCT03085095 ↗ | A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer | Active, not recruiting | Myovant Sciences GmbH | Phase 3 | 2017-04-18 | The purpose of this study is to determine the efficacy and safety of relugolix 120 milligrams (mg) orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (< 50 nanograms/deciliter [ng/dL]) in participants with androgen-sensitive advanced prostate cancer. |
| NCT04906395 ↗ | Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer | Recruiting | Tolmar Inc. | Phase 3 | 2021-07-01 | This is a phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 to suppress ovarian function in premenopausal women with HR+, HER2-negative breast cancer. The study will also aim to assess administration of TOL2506 in men with HR+ breast cancer. Study duration, for individual subjects, will be up to 57 weeks, including a Screening Period of up to 9 weeks, a Treatment Period of 48 weeks, and an End of Study Visit (Visit 8, Week 48). Eligible subjects will enter into the Treatment Period in 1 of 2 groups: those who will receive tamoxifen concurrently with TOL2506 or those who will initiate therapy with an AI (letrozole, anastrozole, or exemestane) beginning 6 weeks after the first administration of TOL2506, upon confirmation that estradiol (E2) levels of < 20 pg/mL have been achieved. After Week 12, subjects will be allowed to switch from receiving an AI to receiving tamoxifen or from tamoxifen to AI at the discretion of the Investigator. However, a switch is not permitted 28 days prior to a dosing visit. At the end of the Treatment Period, subjects will be eligible for compassionate use of TOL2506 (expanded access) until TOL2506 receives marketing approval and is commercially available. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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