Improved bleeding profile and tolerability of tibolone versus transdermal E₂/NETA treatment in postmenopausal women with female sexual dysfunction

Abstract

Objectives To compare the incidence of vaginal spotting/bleeding events and breast pain between therapy with tibolone 2.5 mg and continuous combined transdermal estradiol (E₂)/norethisterone acetate (NETA) 50 μg/140 μg after 24 weeks of treatment.

Methods A double-blind, double-dummy, randomized, controlled trial was performed and assessments were performed at baseline, week 12 and week 24. Bleeding/spotting events were recorded in a daily diary. Breast signs and symptoms were collected as adverse events.

Results A total of 403 women (mean age 56 years) were randomized. Bleeding/spotting events during weeks 1–12 with tibolone and E₂/NETA were experienced by 16% and 56% of women, respectively (p < 0.001). The corresponding percentages during weeks 13–24 were 12% and 51%, respectively (p < 0.001). E₂/NETA was significantly more likely than tibolone to be associated with vaginal hemorrhage (11% vs. 0%; p < 0.001) and breast signs and symptoms (11% vs. 4%; p = 0.015). Early discontinuations resulting from adverse events were significantly more common in the E₂/NETA group than in the tibolone group (20% vs. 12%), primarily related to withdrawal due to vaginal hemorrhage (8% vs. 0%).

Conclusions Tibolone has a significantly better tolerability profile than transdermal E₂/NETA as measured by vaginal bleeding, breast pain and treatment continuation.

Key words:

• Menopause
• Tibolone
• Tolerability
• Transdermal Estrogen/Progestogen Therapy
• Vaginal Bleeding