Active Ingredient History
Gonadorelin is a synthetic decapeptide prepared using solid phase peptide synthesis. GnRH is responsible for the release of follicle stimulating hormone and leutinizing hormone from the anterior pitutitary. In the pituitary GnRH stimulates synthesis and release of FSH and LH, a process that is controlled by the frequency and amplitude of GnRH pulses, as well as the feedback of androgens and estrogens. The pulsatility of GnRH secretion has been seen in all vertebrates, and it is necessary to ensure a correct reproductive function. Thus a single hormone, GnRH, controls a complex process of follicular growth, ovulation, and corpus luteum maintenance in the female, and spermatogenesis in the male. Its short half life requires infusion pumps for its clinical use. Gonadorelin is used for the treatment of amenorrhea, delayed puberty, and infertility the administration of gonadorelin is used to simulate the physiologic release of GnRH from the hypothalamus in treatment of delayed puberty, treatment of infertility caused by hypogonadotropic hypogonadism, and induction of ovulation in those women with hypothalamic amenorrhea. This results in increased levels of pituitary gonadotropins LH and FSH, which subsequently stimulate the gonads to produce reproductive steroids. NCATS
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
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| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Amenorrhea (approved 1982)
Hypogonadism (approved 1982)
Amenorrhea (Phase 2)
Embryo Transfer (Phase 3)
Fertilization in Vitro (Phase 4)
Gonadotropin-Releasing Hormone (Phase 1)
Hyperprolactinemia (Phase 2)
Hypogonadism (Phase 3)
Infertility (Phase 4)
Kallmann Syndrome (Phase 4)
Ovulation (Phase 4)
Polycystic Ovary Syndrome (Phase 4)
Prostatic Neoplasms (Phase 3)
Puberty, Precocious (Phase 4)
Reproductive Health (Phase 1)
Sleep Disorders, Intrinsic (Early Phase 1)
| Trial | Phase | Start Date | Organizations | Indications |
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