title: Efficacy and safety of 17alpha-hydroxyprogesterone caproate in hormone replacement therapy.
abstract: The aim of the present study was to evaluate the efficacy (in terms of induction of uterine bleeding) and safety (in terms of absence of endometrial hyperplasia) of 17alpha-hydroxyprogesterone caproate (17alpha-HPC) in a therapeutic regimen for hormonal replacement after menopause. Fifty postmenopausal patients received hormone replacement therapy (HRT) for 24 weeks. The treatment regimen consisted of standard estrogen replacement therapy at commonly prescribed doses for the prevention of climacteric symptoms and 341 mg of 17alpha-HPC every 30 days. Enrolled women were told to expect withdrawal bleeding 7-10 days after the administration of 17alpha-HPC. Forty-eight patients completed the trial. In 91.7% of cases, patients experienced the expected pattern, i.e., strict withdrawal bleeding exclusive of any other form of bleeding. Breakthrough bleeding and/or other forms of abnormal bleeding affected only four women. At the 6th month none of the endometrial samplings motivated by endometrial thickness >10 mm and evidence of heterogeneous echogenicity (two cases) was positive for carcinoma. No biopsies had to be performed at the end of the 12th month of treatment. No serious adverse effect where recorded during the study period. In conclusion, our data show the efficacy and safety of 17alpha-HPC in HRT.
authors.affiliation: First Institute of Obstetrics and Gynecology, University La Sapienza, Rome, Italy.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Agostini
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Casini
authors.forename: Loredana
authors.initials: L
authors.lastname: Costabile
authors.forename: Mizar
authors.initials: M
authors.lastname: Paragona
authors.forename: Francesca
authors.initials: F
authors.lastname: Marzano
authors.forename: Vittorio
authors.initials: V
authors.lastname: Unfer
mesh_terms: D000077713:17 alpha-Hydroxyprogesterone Caproate; D002118:Calcium / Q000652:urine; D002979:Climacteric; D003404:Creatinine / Q000652:urine; D004714:Endometrial Hyperplasia / Q000000981:diagnostic imaging; D004717:Endometrium / Q000000981:diagnostic imaging; D004958:Estradiol / Q000008:administration & dosage; D015914:Estrogen Replacement Therapy / Q000379:methods*; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D006908:Hydroxyprogesterones / Q000008:administration & dosage* / Q000009:adverse effects*; D008593:Menopause; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy; D013997:Time Factors; D014463:Ultrasonography; D014592:Uterine Hemorrhage
chemical_list: D004966:Estrogens, Conjugated (USP); D006908:Hydroxyprogesterones; D000077713:17 alpha-Hydroxyprogesterone Caproate; D004958:Estradiol; D003404:Creatinine; D002118:Calcium