A randomized study of the effects of tibolone and transdermal estrogen replacement therapy in postmenopausal women with uterine myomas.

Abstract

OBJECTIVE:

To evaluate the effects of two types of hormone replacement therapy, an estrogen-progestin combination and tibolone, on uterine myomas in menopausal women.

STUDY DESIGN:

Thirty-eight menopausal women with one or more uterine myomas were randomized to treatment with a transdermal system continuously releasing estradiol 50 microg/day combined with oral medroxyprogesterone acetate (MPA) 10 mg/day for 12 days/month or tibolone tablets 2.5 mg/day. The scheduled duration of both treatments was 12 months. Physical examination and abdominal/transvaginal ultrasonography were performed before entering the study and at 3, 6 and 12 months of treatment. At each ultrasonography the overall uterine volume was determined as well as the size of each myoma and the endometrial thickness and characteristics.

RESULTS:

No statistically significant difference was detected between the two groups at any time during treatment. However, within-group analysis showed a significant increase of uterine volume and of myoma number and size in the estrogen-progestin group, whereas no such increase occurred in the patients treated with tibolone. Also, the mean endometrium width increased significantly from baseline to the end of treatment in the estrogen-progestin group, but not in the tibolone group.

CONCLUSIONS:

Tibolone seems a valid alternative in menopausal patients with uterine myomas as it provides adequate relief from menopausal symptoms and avoids volume increase of the uterus and myomas.

• Authors: L Fedele, S Bianchi, R Raffaelli, G Zanconato
• Journal: European journal of obstetrics, gynecology, and reproductive biology (Eur J Obstet Gynecol Reprod Biol) Vol. 88 Issue 1 Pg. 91-4 (Jan 2000) ISSN: 0301-2115 [Print] Ireland
• PMID: 10659924 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

• Antineoplastic Agents, Hormonal
• Norpregnenes
• Progesterone Congeners
• Estradiol
• tibolone
• Medroxyprogesterone

Topics

• Administration, Cutaneous
• Antineoplastic Agents, Hormonal (administration & dosage)
• Drug Therapy, Combination
• Estradiol (administration & dosage)
• Estrogen Replacement Therapy
• Female
• Humans
• Leiomyoma (drug therapy)
• Medroxyprogesterone (administration & dosage)
• Middle Aged
• Norpregnenes (administration & dosage)
• Progesterone Congeners (administration & dosage)
• Treatment Outcome
• Uterine Neoplasms (drug therapy)