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A randomized, open-label study of conjugated equine estrogens plus medroxyprogesterone acetate versus tibolone: effects on symptom control, bleeding pattern, lipid profile and tolerability.
Climacteric. 2002 Mar; 5(1):60-9.C

Abstract

OBJECTIVE

To compare the effects of continuous combined conjugated equine estrogens plus medroxyprogesterone acetate (CEE/MPA) with those of tibolone on symptom control, bleeding pattern, lipid profile and tolerability in postmenopausal women.

METHODS

This was a randomized, open-label, parallel-group, multicenter study. Generally healthy postmenopausal women with an intact uterus and no contraindications to hormone replacement therapy (HRT) or tibolone were enrolled. Each subject was randomly assigned to receive CEE/MPA 0.625 mg-5.0 mg or tibolone 2.5 mg daily for 13 treatment cycles, each of 28 days.

RESULTS

A total of 85 subjects were enrolled and received at least one dose of study medication, of which 76 (89.4%) subjects completed the study (n = 40, CEE/MPA; n = 36, tibolone). The incidence of postmenopausal symptoms decreased significantly over time in both treatment groups, compared with baseline, including significant decreases in the incidence of urogenital and sexual health symptoms. Significant differences in symptom control (other than hot flushes) were observed between treatment groups in a few different cycles for different symptoms, but no consistent or clinically significant trends were observed. No statistically significant differences in the incidence of bleeding were observed between treatment groups after cycle 4. Significant decreases in total cholesterol (5.6%) and low-density lipoprotein (LDL) cholesterol (7.5%) were observed at cycle 13, compared with baseline, in the CEE/MPA group, and significant decreases in high-density lipoprotein (HDL) cholesterol (8.5%) and triglycerides (13.7%) were observed at cycle 13, compared with baseline, in the tibolone group. Significant weight gain was observed at cycle 13 in the tibolone group (3.05 kg), compared with the CEE/MPA group (0.96 kg). The incidences of adverse events were similar in both treatment groups.

CONCLUSIONS

Women treated with CEE/MPA or tibolone showed significant improvement of postmenopausal symptoms, including urogenital and sexual health symptoms, and had similar bleeding patterns after four cycles of therapy. CEE/MPA and tibolone each induced a different mix of changes in the lipid profile.

Authors+Show Affiliations

Federal University of São Paulo, São Paulo.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11974560

Citation

Baracat, E C., et al. "A Randomized, Open-label Study of Conjugated Equine Estrogens Plus Medroxyprogesterone Acetate Versus Tibolone: Effects On Symptom Control, Bleeding Pattern, Lipid Profile and Tolerability." Climacteric : the Journal of the International Menopause Society, vol. 5, no. 1, 2002, pp. 60-9.
Baracat EC, Barbosa IC, Giordano MG, et al. A randomized, open-label study of conjugated equine estrogens plus medroxyprogesterone acetate versus tibolone: effects on symptom control, bleeding pattern, lipid profile and tolerability. Climacteric. 2002;5(1):60-9.
Baracat, E. C., Barbosa, I. C., Giordano, M. G., Haidar, M. A., Marinho, R. M., Menegocci, J. C., Morais, K. M., Tomaz, G., & Wehba, S. (2002). A randomized, open-label study of conjugated equine estrogens plus medroxyprogesterone acetate versus tibolone: effects on symptom control, bleeding pattern, lipid profile and tolerability. Climacteric : the Journal of the International Menopause Society, 5(1), 60-9.
Baracat EC, et al. A Randomized, Open-label Study of Conjugated Equine Estrogens Plus Medroxyprogesterone Acetate Versus Tibolone: Effects On Symptom Control, Bleeding Pattern, Lipid Profile and Tolerability. Climacteric. 2002;5(1):60-9. PubMed PMID: 11974560.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, open-label study of conjugated equine estrogens plus medroxyprogesterone acetate versus tibolone: effects on symptom control, bleeding pattern, lipid profile and tolerability. AU - Baracat,E C, AU - Barbosa,I C, AU - Giordano,M G, AU - Haidar,M A, AU - Marinho,R M, AU - Menegocci,J C, AU - Morais,K M, AU - Tomaz,G, AU - Wehba,S, PY - 2002/4/27/pubmed PY - 2002/10/9/medline PY - 2002/4/27/entrez SP - 60 EP - 9 JF - Climacteric : the journal of the International Menopause Society JO - Climacteric VL - 5 IS - 1 N2 - OBJECTIVE: To compare the effects of continuous combined conjugated equine estrogens plus medroxyprogesterone acetate (CEE/MPA) with those of tibolone on symptom control, bleeding pattern, lipid profile and tolerability in postmenopausal women. METHODS: This was a randomized, open-label, parallel-group, multicenter study. Generally healthy postmenopausal women with an intact uterus and no contraindications to hormone replacement therapy (HRT) or tibolone were enrolled. Each subject was randomly assigned to receive CEE/MPA 0.625 mg-5.0 mg or tibolone 2.5 mg daily for 13 treatment cycles, each of 28 days. RESULTS: A total of 85 subjects were enrolled and received at least one dose of study medication, of which 76 (89.4%) subjects completed the study (n = 40, CEE/MPA; n = 36, tibolone). The incidence of postmenopausal symptoms decreased significantly over time in both treatment groups, compared with baseline, including significant decreases in the incidence of urogenital and sexual health symptoms. Significant differences in symptom control (other than hot flushes) were observed between treatment groups in a few different cycles for different symptoms, but no consistent or clinically significant trends were observed. No statistically significant differences in the incidence of bleeding were observed between treatment groups after cycle 4. Significant decreases in total cholesterol (5.6%) and low-density lipoprotein (LDL) cholesterol (7.5%) were observed at cycle 13, compared with baseline, in the CEE/MPA group, and significant decreases in high-density lipoprotein (HDL) cholesterol (8.5%) and triglycerides (13.7%) were observed at cycle 13, compared with baseline, in the tibolone group. Significant weight gain was observed at cycle 13 in the tibolone group (3.05 kg), compared with the CEE/MPA group (0.96 kg). The incidences of adverse events were similar in both treatment groups. CONCLUSIONS: Women treated with CEE/MPA or tibolone showed significant improvement of postmenopausal symptoms, including urogenital and sexual health symptoms, and had similar bleeding patterns after four cycles of therapy. CEE/MPA and tibolone each induced a different mix of changes in the lipid profile. SN - 1369-7137 UR - https://www.unboundmedicine.com/medline/citation/11974560/A_randomized_open_label_study_of_conjugated_equine_estrogens_plus_medroxyprogesterone_acetate_versus_tibolone:_effects_on_symptom_control_bleeding_pattern_lipid_profile_and_tolerability_ DB - PRIME DP - Unbound Medicine ER -