Clinical experience with trimegestone as a new progestin in HRT.
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 17beta-estradiol (17beta-E2) and conjugated equine estrogens (CEE). TMG-containing HRT agents were effective in relieving vasomotor symptoms and providing protection from endometrial hyperplasia with < or =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 17beta-E2 and CEE/TMG combinations have shown improved bone mineral density and quality-of-life assessments. Both continuous combined and sequential regimens of 17beta-E2/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.
Grubb
Gary
G
Women's Health Clinical Research and Development, 500 Arcola Road, Collegeville, PA 19426, USA. grubbg@wyeth.com
Spielmann
Daniele
D
Pickar
James
J
Constantine
Ginger
G
D000328:Adult; D015519:Bone Density; D002986:Clinical Trials as Topic; D004958:Estradiol / Q000378:metabolism; D005260:Female; D020249:Hormone Replacement Therapy; D006801:Humans; D008593:Menopause / Q000187:drug effects; D008875:Middle Aged; D017698:Postmenopause; D011372:Progestins / Q000627:therapeutic use*; D011397:Promegestone / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D013997:Time Factors
D011372:Progestins; C050319:trimegestone; D004958:Estradiol; D011397:Promegestone