Abstract | BACKGROUND AND OBJECTIVES: METHODS: Subjects were randomized in a 1:1:2 ratio to tibolone 1.25 mg/d, 2.5 mg/d, and CEE/MPA, respectively. The one-sided 95% confidence interval (CI) has been evaluated for the incidence of abnormal endometrial histology ( hyperplasia or carcinoma) and hyperplasia and carcinoma separately for each of the two treatment groups and the treatment groups combined after 1 and 2 yr of treatment with tibolone, compared with CEE/MPA. RESULTS: A total of 3240 women were randomized, with 3224 receiving at least one dose of study medication. The incidence and upper one-sided 95% CI for the incidence of abnormal endometrium ( hyperplasia or carcinoma), and hyperplasia and carcinoma separately, were calculated at end point, yr 1, and yr 2. The incidence (upper one-sided 95% CI) of abnormal endometrium at end point was 0.0 (0.5), 0.0 (0.4), and 0.2 (0.5) in the tibolone 1.25 mg, 2.5 mg, and CEE/MPA groups, respectively. During the entire treatment period, amenorrhea was reported more frequently with tibolone 1.25 mg (78.7%) and 2.5 mg (71.4%) than CEE/MPA (44.9%). CONCLUSION:
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Authors | David F Archer, Susan Hendrix, J Chris Gallagher, Janice Rymer, Sven Skouby, Alex Ferenczy, Wil den Hollander, Victoria Stathopoulos, Frans A Helmond |
Journal | The Journal of clinical endocrinology and metabolism
(J Clin Endocrinol Metab)
Vol. 92
Issue 3
Pg. 911-8
(Mar 2007)
ISSN: 0021-972X [Print] United States |
PMID | 17192288
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Drug Combinations
- Estrogens, Conjugated (USP)
- Norpregnenes
- Medroxyprogesterone Acetate
- tibolone
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Topics |
- Aged
- Carcinoma
(chemically induced, epidemiology)
- Cohort Studies
- Double-Blind Method
- Drug Combinations
- Endometrial Hyperplasia
(chemically induced, epidemiology)
- Endometrial Neoplasms
(chemically induced, epidemiology)
- Endometrium
(drug effects)
- Estrogen Replacement Therapy
(adverse effects)
- Estrogens, Conjugated (USP)
(administration & dosage)
- Female
- Humans
- Medroxyprogesterone Acetate
(administration & dosage)
- Middle Aged
- Norpregnenes
(adverse effects, pharmacology, therapeutic use)
- Pain
(chemically induced)
- Uterine Hemorrhage
(chemically induced, epidemiology)
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