Clinical profile of a new hormone replacement therapy containing 2 mg 17β-estradiol and 10 mg dydrogesterone

• Published in: Maturitas Vol. 34; no. 3; pp. 267 - 273
• Main Authors: Sator, Michael O, Nagele, Fritz, Sator, Paul, Travica, Sanja, Gruber, Doris, Huber, Johannes C
• Format: Journal Article
• Language: English
• Published: Shannon Elsevier Ireland Ltd 31.03.2000; Elsevier Science
• Subjects: 17β-estradiol; Adult; Austria; Biological and medical sciences; Drug Therapy, Combination; Dydrogesterone; Dydrogesterone - pharmacology; Estradiol - pharmacology; Female; Hormone Replacement Therapy; Hormones. Endocrine system; Humans; Medical sciences; Menopause - drug effects; Middle Aged; Patient Acceptance of Health Care; Pharmacology. Drug treatments; Prospective Studies; Austria; Dydrogesterone; Hormone replacement therapy; 17β-estradiol; Human; Drug compliance; Chemotherapy; Replacement therapy; Menopause; Estrogen; 17β-Estradiol; Female; Sex steroid hormone; Progestagen
• ISSN: 0378-5122; 1873-4111
• DOI: 10.1016/S0378-5122(99)00110-3

Objective: Patient’s acceptability, compliance, and effectiveness of a new sequential hormone replacement regimen containing 2 mg 17β-estradiol and 10 mg dydrogesterone, were assessed in a 3-month, open, multicentre study involving 110 menopausal women. Methods: A specially designed menopause score was used to assess the severity of menopausal symptoms, each symptom being graded at baseline and after 3 months on a four-point scale. Bleeding data were recorded by the patient on a diary card. Serum hormone levels including FSH, LH, E2, P, PRL, DHEA-S, T, SHBG were checked at the initial visit and at the end of the study. Results: After 3 months of treatment, all but four of the 34 climacteric symptoms investigated showed a significant improvement. There were no significant changes noted in body weight. The average duration and flow of bleeding showed no significant changes during hormone replacement therapy (HRT). There were no serious adverse events related to treatment. Conclusion: The 17β-estradiol/dydrogesterone combination HRT reduced effectively climacteric symptoms, showed no significant changes in endometrial thickness as determined by transvaginal ultrasonography and provided excellent cycle control.