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.
OBJECTIVE
To evaluate the effects of long-term administration of GnRH agonist (GnRH-a) plus tibolone for uterine leiomyomatosis.


METHODS
Prospective open clinical trial.


METHODS
Department of Gynecology, Obstetrics and Pathophysiology of Human Reproduction, University of Naples "Federico II", Naples, Italy.


METHODS
Twenty-five subjects with symptomatic uterine leiomyomas.


METHODS
Treatment for 2 years with leuprolide acetate (3.75 mg IM every 28 days) and tibolone (2.5 mg/d per os).


METHODS
Uterine and uterine leiomyoma sizes, endometrial thickness, lumbar spine bone mineral density (BMD), bone metabolism, lipid profile, myoma-related symptoms at baseline and every 6 months. Hot flashes and vaginal bleeding episodes recorded in a daily symptom diary.


RESULTS
After 6 months of treatment, a significant reduction was observed in uterine and leiomyoma volumes and myoma-related symptoms compared with baseline values. No significant change was observed in bone turnover, lumbar BMD, or serum total cholesterol, low-density lipoprotein cholesterol, or triglyceride levels. High-density lipoprotein cholesterol values were significantly lower than baseline values after 6 months of treatment but not after 18 months of therapy. A low mean number of hot flashes per day was observed.


CONCLUSIONS
Long-term administration of GnRH-a plus tibolone reduces hot flashes and prevents bone loss without changing the lipid profile.
Palomba
S
S
Department of Gynecology, Obstetrics and Pathophysiology of Human Reproduction, University of Naples Federico II, Italy.
Affinito
P
P
Di Carlo
C
C
Bifulco
G
G
Nappi
C
C
D000328:Adult; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D015519:Bone Density / Q000187:drug effects*; D004717:Endometrium / Q000473:pathology; D019160:Endosonography; D005260:Female; D007987:Gonadotropin-Releasing Hormone / Q000819:agonists*; D006801:Humans; D015907:Hysteroscopy; D007889:Leiomyoma / Q000188:drug therapy*; D050356:Lipid Metabolism; D008875:Middle Aged; D009652:Norpregnenes / Q000008:administration & dosage*; D013997:Time Factors; D014594:Uterine Neoplasms / Q000188:drug therapy*; D014666:Vasomotor System / Q000187:drug effects*
D018931:Antineoplastic Agents, Hormonal; D009652:Norpregnenes; D007987:Gonadotropin-Releasing Hormone; C027385:tibolone