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

AbstractOBJECTIVE:
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.
AuthorsMaria Morais-Socorro, Maciel Alvaro Cavalcanti, Rand Martins, Paulo Neto Francisco, Adriana Rezende, George Azevedo, Maria Almeida
JournalGynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology (Gynecol Endocrinol) Vol. 28 Issue 6 Pg. 483-7 (Jun 2012) ISSN: 1473-0766 [Electronic] England
PMID22132809 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Estrogen Receptor Modulators
  • Norpregnenes
  • Placebos
  • tibolone
Topics
  • Administration, Oral
  • Adult
  • Double-Blind Method
  • Endometrium (anatomy & histology, diagnostic imaging, drug effects)
  • Estrogen Receptor Modulators (administration & dosage, adverse effects, therapeutic use)
  • Female
  • Hot Flashes (epidemiology)
  • Humans
  • Menopause (drug effects, physiology)
  • Middle Aged
  • Norpregnenes (administration & dosage, adverse effects, therapeutic use)
  • Organ Size (drug effects)
  • Placebos
  • Treatment Outcome
  • Ultrasonography

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