Clinical experience with trimegestone as a new progestin in HRT

• Published in: Steroids 2003-11, Vol.68 (10), p.921-926
• Main Authors: Grubb, Gary, Spielmann, Daniele, Pickar, James, Constantine, Ginger
• Format: Article
• Language: English
• Subjects: Adult; Biological and medical sciences; Bone Density; CEE; Clinical Trials as Topic; Estradiol; Estradiol - metabolism; Female; Fundamental and applied biological sciences. Psychology; Hormone Replacement Therapy; Humans; Menopause - drug effects; Middle Aged; Postmenopause; Progestins - therapeutic use; Promegestone - analogs & derivatives; Promegestone - therapeutic use; Time Factors; Trimegestone; Vertebrates: endocrinology
• ISSN: 0039-128X; 1878-5867
• DOI: 10.1016/j.steroids.2003.09.001

Trimegestone (TMG) is a novel, 19-norpregnane progestin, which demonstrates endometrial selectivity with a reduced progestin-related side effect profile when compared to several other currently marketed progestins. TMG has been studied in combination with 17β-estradiol (17β-E 2) and conjugated equine estrogens (CEE). TMG-containing HRT agents were effective in relieving vasomotor symptoms and providing protection from endometrial hyperplasia with ≤1% hyperplasia. In clinical trials with sequential regimens, TMG provided predictable withdrawal bleeding associated with a low incidence of irregular and prolonged bleeding. Clinical studies of continuous combined regimens of estrogen/TMG combinations demonstrated high levels of amenorrhea. Both 17β-E 2 and CEE/TMG combinations have shown improved bone mineral density and quality-of-life assessments. Both continuous combined and sequential regimens of 17β-E 2/TMG and CEE/TMG have a favorable clinical profile. TMG provides an important new option for the treatment of postmenopausal symptoms and the prevention of osteoporosis.