Safety and efficacy of tibolone and menopausal transition: a randomized, double-blind placebo-controlled trial

Abstract

Objective: To evaluate the efficacy, safety and tolerability of Tibolone use during the menopausal transition (MT). Methods: Sixty-five healthy women aged 40–55 years (48.5 ± 3.5 years) were recruited for a randomized, double-blind controlled trial. Thirty participants were recruited to receive oral Tibolone 2.5 mg/day – Tibolone Group (TG), and 35 participants were assigned to the Placebo Group (PG), which received one capsule of lactose/day. Both groups were treated for 12 consecutive weeks. The Blatt-Kupperman Menopausal Index (KMI) and the Greene Climacteric Scale (GCS) were used. The glycaemic and lipid profiles, biochemical measures of hepatic function and endometrial thickness were measured for safety. A daily registry of complaints related to the treatment was maintained, and anthropometric measures were obtained to assess tolerability. Results: A total of 57 women completed the study. After 12 weeks of Tibolone use, the total score and percentage of the KMI and GCS were significantly decreased compared to baseline, which reflected the efficacy of the treatment of climacteric symptoms. The improvement in blood biochemistry, endometrial atrophy and maintenance of the anthropometrical measures reflected the safety of Tibolone use. The absence of serious side effects demonstrated good tolerability for Tibolone use. Conclusions: The results showed good efficacy, tolerability and safety of Tibolone use during the MT.

Keywords::

• Endometrium
• hormone replacement therapy
• menopausal transition
• menopause
• tibolone

Declaration of Interest: This work was supported by grant 481011/2007-2 from the CNPq and the assignment of the medication (ReduClin^® 2.5 mg) from the Farmoquímica, Brazil, and had logistical support from the Municipal Health System of the City of Parnamirim (Brazil) and Federal University of Rio Grande do Norte and Potiguar University.