Effects of Tibolone and Continuous Combined Conjugated Equine Estrogen/Medroxyprogesterone Acetate on the Endometrium and Vaginal Bleeding: Results of the OPAL Study

Ultra-low-dose continuous combined estradiol and norethisterone acetate: improved bleeding profile in postmenopausal women

“…These findings were associated with a higher rate of continuation than has been reported with other ccEPT regimens 13,15,30,37 . The ultra-low-dose regimens are also consistent with the advice from regulatory authorities to use the lowest effective dose.…”

“…In contrast to many other studies investigating bleeding pattern, the CHOICE trial provided data for up to only 6 months of treatment. However, the available literature on the pattern of bleeding over time in postmenopausal women using ccEPT indicates that bleeding is more common in the initial months of use 17,23,29 and that it gradually declines with duration of therapy 17,30,31 . The data from the E2/NETA 0.1 group show the same pattern, so it is expected that, with continued use beyond 6 months, the rate of amenorrhea would improve further.…”

Tibolone in postmenopausal women: a review based on recent randomised controlled clinical trials

“…T users did not show a significant increase in double-wall endometrial thickness and a better tolerability of T compared to EPT was confirmed. These findings were consistent with the results of another randomised, PL-controlled clinical trial (OPAL study) [85], whose secondary objective was to assess the effects of T, continuous combined EPT and PL on the endometrium. The incidence of endometrial proliferation was 1.4%, 4.8%, 0%, for T, EPT and PL group, respectively, while cancer was assessed in 1 case for T and 1 in PL.…”

Tibolone: the way to beat many a postmenopausal ailments

“…Key findings regarding adverse endometrial effects of tibolone can be driven from clinical trials, such as THEBES (Tibolone Hystology of the Endometrium and Breast Endpoints Study) [50] , OPAL (Osteoporosis Prevention and Arterial Effects of Tibolone) study [51] and other clinical studies [52] .…”