A randomized,open-label study of conjugated equine estrogens plus medroxyprogesterone acetate versus tibolone: effects on symptom control, bleeding pattern, lipid profile and tolerability

Baracat, Edmund Chada; Barbosa, Ione Cristina; Giordano, Maria; Haidar, Mauro Abi; Marinho, Ricardo Mello; Menegocci, J. C.; Morais, K. M.; Tomaz, Geraldez; Wehba, Salim

doi:10.1080/cmt.5.1.60.69

Cited by 30 publications

(4 citation statements)

References 14 publications

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“…[16][17][18][19] Higher dose estrogen-progestogen combinations compare unfavourably with tibolone with respect to bleeding and breast-related adverse events (AEs), whereas lower dose regimens have not been compared with tibolone. 8,9,[20][21][22] Therefore, the aim of the present study was to compare the occurrence of vaginal bleeding, efficacy and tolerability of 2.5 mg tibolone with 1 mg E 2 and 0.5 mg NETA.…”

Section: Introductionmentioning

confidence: 99%

Tibolone and low‐dose continuous combined hormone treatment: vaginal bleeding pattern, efficacy and tolerability

Hammar

Weijer

et al. 2007

BJOG

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ObjectivesThe primary objective was to compare the vaginal bleeding pattern during administration of tibolone and low-dose continuous combined estradiol plus norethisterone acetate (E 2 / NETA). The secondary objectives were efficacy on vasomotor symptoms and vaginal atrophy.Design A randomised, double-blind, double-dummy, group comparative intervention trial.Setting Multicentre study executed in 32 centres in 7 European countries.Sample Five hundred and seventy-two healthy symptomatic postmenopausal women, aged 45-65 years.Methods Participants were randomised to receive 2.5 mg tibolone or 1 mg 17b estradiol plus 0.5 mg norethisterone acetate (E 2 / NETA) daily for 48 weeks.Main outcome measures Prevalence of vaginal bleeding, hot flushes and adverse events.Results The incidence of bleeding was significantly lower in the tibolone group during the first 3 months of treatment (18.3 versus 33.1%; P < 0.001) when compared with the E 2 /NETA group. This effect on the bleeding pattern was sustained throughout the study, although reaching statistical significance again only in 7-9 months of treatment (11 versus 19%; P < 0.05). In both treatment groups, vasomotor symptoms and vaginal atrophy were significantly reduced to a similar extent when compared with baseline. The prevalence of breast pain/tenderness was significantly lower with tibolone compared with E 2 /NETA (3.2 versus 9.8%; P < 0.001).Conclusion Tibolone reduces menopausal symptoms to a similar extent as conventional low-dose continuous combined hormone therapy but causes significant less vaginal bleeding in the first 3 months of treatment. This constitutes an important argument for woman adherence to therapy.

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Section: Introductionmentioning

confidence: 99%

Tibolone and low‐dose continuous combined hormone treatment: vaginal bleeding pattern, efficacy and tolerability

Hammar

Weijer

et al. 2007

BJOG

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“…25 In studies comparing tibolone to treatment with estrogen-progestin therapy, there appears to be no difference in effectiveness at vasomotor symptom control; 26,27 however, there were fewer bleeding episodes with tibolone reported in Hammar et al's 27 double-blind RCT. These trials had no placebo group; therefore the magnitude of the improvement in flushes and sweats could not be ascertained.…”

Section: Progesteronementioning

confidence: 94%

Hot flushes: are there effective alternatives to estrogen?

Sassarini

Lumsden

2010

Menopause International

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Hot flushes are the most common indication for the prescription of hormone replacement therapy (HRT) since it is effective in over 80% of cases. In 1995, 37% of American women took HRT, principally for this purpose. However, over the last five years, publications such as those from the Women's Health Initiative (WHI) have caused concern among women since they perceive that the risks outweigh the benefits. Following this publication, half of the women taking HRT in the UK, USA and New Zealand discontinued HRT. With the discontinuation of estrogen many women re-developed hot flushes; however only a small number (18%) of women report restarting hormone therapy. The majority of these (76%) for the recurrence of severe hot flushes or night sweats. Alternatives are available, but limited knowledge on aetiology and mechanisms of hot flushing represents a major obstacle for the development of new, targeted, non-hormonal treatments, and no current alternatives are as effective as estrogen.

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“…Tibolone expresses a variable affinity for the estrogen, progesterone and androgen receptors and may function as a selective tissue estrogenic activity regulator (STEAR) 18 . Raloxifene is a non-steroidal benzothiophene derivative, classified as a selective estrogen receptor modulator (SERM) 19 .…”

Section: Introductionmentioning

confidence: 99%

Circulating levels of atherogenesis-associated adipocytokines and apoptotic markers are differentially influenced by hormone therapy, tibolone and raloxifene in healthy postmenopausal women

et al. 2008

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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

Cited by 30 publications

References 14 publications

Tibolone and low‐dose continuous combined hormone treatment: vaginal bleeding pattern, efficacy and tolerability

Tibolone and low‐dose continuous combined hormone treatment: vaginal bleeding pattern, efficacy and tolerability

Hot flushes: are there effective alternatives to estrogen?

Circulating levels of atherogenesis-associated adipocytokines and apoptotic markers are differentially influenced by hormone therapy, tibolone and raloxifene in healthy postmenopausal women

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