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Title: Randomized cross-over study of a 21-day versus a 28-day hormone replacement therapy (HRT)
Authors: McCarthy, T. 
Dramusic, V.
Carter, R.
Costales, A.
Ratnam, S.S. 
Keywords: Conjugated equine estrogens
Cyproterone acetate
Estradiol valerate
Opposed sequential HRT
Symptom and mood profile
Issue Date: 1995
Citation: McCarthy, T., Dramusic, V., Carter, R., Costales, A., Ratnam, S.S. (1995). Randomized cross-over study of a 21-day versus a 28-day hormone replacement therapy (HRT). Maturitas 22 (1) : 13-23. ScholarBank@NUS Repository.
Abstract: Objectives: To compare the occurrence of climacteric symptoms at two points in the cycle, identified as minE (phase of minimum estrogen effect) and MaxP (phase of maximum progesterone effect). Methods: Prospective randomized cross-over study in postmenopausal women currently on HRT comparing two opposed, sequential formulations: a regimen of 21 tablets containing estradiol valerate (EV) opposed with cyproterone acetate (CPA) in the last 10 tablets, versus a regimen of 28 tablets of conjugated equine estrogens (GEE), the last 12 tablets of which were taken together with norgestrel (NG). Outcome measures: Incidence of 24 climacteric complaints assessed at the specified days of the cycle corresponding to mine (day 6 or 7) and MaxP (day 27 or 28) Results: Contrary to the hypothesis that estrogen- dependent symptoms will recur at mine of the 21-day regimen, no significant differences were noted with the regimen containing 28 days of CEE, which served as the control. There were more complaints with the CEE + NG formulation at both mine and MaxP. Of the 38 patients, 63% preferred the EV + CPA regimen, 18.4% the CEE + NG regimen and 18.4% rated both preparations as equal. Conclusions: The 7-day pause in the 21-day formulation containing EV + CPA did not affect efficacy; it was as effective in relieving climacteric symptoms as the regimen containing 28 days of estrogen. Based on the frequency of complaints both at mine and MaxP, the EV + CPA formulation induced a more acceptable symptom and mood profile.
Source Title: Maturitas
ISSN: 03785122
DOI: 10.1016/0378-5122(95)00905-Z
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