Tibolone and menopausal transition: a randomized, double-blind, placebo-controlled trial
Menopausal Transition; Perimenopause; Tibolone; Greene Climateric Scale (GCS); Blatt-Kupperman Menopausal Index; Climacteric Syndrome (CS).
To evaluate the efficacy, the safety profile and tolerability of the use of Tibolone in the climacteric syndrome (CS) in the menopausal transition (MT) a randomized, double-blind, controlled study, was conducted with a sample comprised of sixty-five healthy women, with age between 40 and 55 years old (48.5 ±35) in MT. Each participant was randomly assigned either to the Tibolone Group (TG), which received 2.5 mg/day of tibolone orally, or the Placebo Group (PG) which received 1 capsule/lactose/day during 12 week in a row.To evaluate the efficacy, the Blatt and Kupperman Menopausal Index (KMI) and Greene Climacteric Scale (GCS) were used; to test safety, the Glycemic and lipid profile, biochemical study of hepatic function and endometrial thickness measure was used; and to test tolerability, a daily registry of complaints related to the treatment was made. After 12 weeks of treatment, the tibolone had a significantly superior effect to placebo in the reduction of the CS and in the improvement of the lipid and glycemic profile; the variables of the hepatic evaluation showed no alteration and the endometrial thickness reduced 1.6 mm in the TG . There was no report of collateral effects enough to interrupt the treatment by the Safety Committee. The results showed efficacy, a good tolerability with improvement on the glycemic and lipid profile of women in the MT. The endometrial atrophy suggests a possible security issue for the use of tibolone as therapeutic agent in the menopausal transition.