Long-term administration of tibolone plus gonadotropin-releasing hormone agonist for the treatment of uterine leiomyomas: effectiveness and effects on vasomotor symptoms, bone mass, and lipid profiles
S. Palomba et al., Long-term administration of tibolone plus gonadotropin-releasing hormone agonist for the treatment of uterine leiomyomas: effectiveness and effects on vasomotor symptoms, bone mass, and lipid profiles, FERT STERIL, 72(5), 1999, pp. 889-895
Objective: To evaluate the effects of long-term administration of GnRH agon
ist (GnRH-a) plus tibolone for uterine leiomyomatosis.
Design: Prospective open clinical trial.
Setting: Department of Gynecology, Obstetrics and Pathophysiology of Human
Reproduction, University of Naples "Federico II", Naples, Italy.
Patient(s): Twenty-five subjects with symptomatic uterine leiomyomas.
Intervention(s): Treatment for 2 years with leuprolide acetate (3.75 mg IM
every 25 days) and tibolone (2.5 mg/d per os).
Main Outcome Measure(s): Uterine and uterine leiomyoma sizes, endometrial t
hickness, lumbar spine bone mineral density (BMD), bone metabolism, lipid p
rofile, myoma-related symptoms at baseline and every 6 months. Hot flashes
and vaginal bleeding episodes recorded in a daily symptom diary.
Result(s): After 6 months of treatment, a significant reduction was observe
d in uterine and leiomyoma volumes and myoma-related symptoms compared with
baseline values. No significant change was observed in bone turnover, lumb
ar BMD, or serum total cholesterol, low-density lipoprotein cholesterol, or
triglyceride levels. High-density lipoprotein cholesterol values were sign
ificantly lower than baseline values after 6 months of treatment but not af
ter 18 months of therapy. A low mean number of hot flashes per day was obse
rved.
Conclusion(s): Long-term administration of GnRH-a plus tibolone reduces hot
flashes and prevents bone loss without changing the lipid profile. (Fertil
Steril(R) 1999;72:889-95. (C)1999 by American Society for Reproductive Med
icine.).