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Randomized cross-over study of a 21-day versus a 28-day hormone replacement therapy (HRT)
T McCarthy1, V Dramusic, R Carter
1Department of Obstetrics and Gynecology, National University Singapore.
Maturitas
|June 1, 1995
Summary
The estradiol valerate (EV) plus cyproterone acetate (CPA) regimen effectively relieved menopausal symptoms, showing no significant difference compared to conjugated equine estrogens (CEE). Patients preferred the EV+CPA formulation for its acceptable symptom and mood profile.
Area of Science:
- Reproductive Endocrinology
- Menopause Management
- Pharmacology of Hormone Replacement Therapy (HRT)
Background:
- Menopausal hormone therapy (HRT) is used to alleviate climacteric symptoms.
- Sequential HRT formulations aim to manage estrogen and progesterone effects throughout the cycle.
- Understanding symptom occurrence during specific hormonal phases is crucial for optimizing HRT efficacy.
Purpose of the Study:
- To compare the incidence of climacteric symptoms during the phase of minimum estrogen effect (minE) and maximum progesterone effect (MaxP).
- To evaluate the efficacy and patient preference between two sequential HRT formulations.
Main Methods:
- A prospective randomized cross-over study involving postmenopausal women on HRT.
- Comparison of a 21-day estradiol valerate (EV) with cyproterone acetate (CPA) regimen versus a 28-day conjugated equine estrogens (CEE) with norgestrel (NG) regimen.
- Assessment of 24 climacteric complaints at minE (days 6-7) and MaxP (days 27-28).
Main Results:
- No significant difference in symptom recurrence at minE between the 21-day EV+CPA and 28-day CEE regimens.
- The CEE+NG formulation resulted in more complaints at both minE and MaxP.
- A majority of patients (63%) preferred the EV+CPA regimen over CEE+NG.
Conclusions:
- The 7-day hormone-free interval in the EV+CPA regimen did not compromise efficacy in relieving climacteric symptoms.
- The EV+CPA formulation demonstrated a more favorable symptom and mood profile compared to CEE+NG.
- Sequential HRT with EV+CPA offers an effective and well-tolerated option for managing menopausal symptoms.
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