Abstract
Objective: To address the endometrial safety of tibolone. Design: The Tibolone Histology of the Endometrium and Breast Endpoints Study (THEBES) is a randomized, double-blind, parallel-group trial of tibolone compared with continuous combined conjugated equine estrogen (CEE) and medroxyprogesterone acetate (MPA). Setting: Multi-country, multi-center ambulatory care setting. Patient(s): A total of 5,185 subjects were screened, and biopsies were obtained from 4,446 women. Intervention(s): Participants were randomized in a 1:1:2 ratio, to tibolone (1.25 or 2.5 mg/d) or CEE-MPA. Main Outcome Measure(s): The one-sided 95% confidence intervals for the incidence of hyperplasia or cancer were evaluated for tibolone compared with CEE-MPA. Result(s): Endometrial biopsy results at baseline: atrophic (87.29%), inactive (0.25%), proliferative (6.12%), secretory (2.86%), menstrual type (0.40%), and hyperplasia (0.18%). Only subjects with atrophic or inactive endometrium were eligible for this study, and 3% of the women at screening either had no tissue (0.18%) or had an amount of tissue that was insufficient for diagnosis (2.72%). Three thousand two hundred forty postmenopausal women with a mean (±SD) age of 54.4 ± 4.4 years and a mean time since menopause of 4.5 ± 3.6 years were randomized. Conclusion(s): The Tibolone Histology of the Endometrium and Breast Endpoints Study is a prospective, randomized clinical trial, designed to provide evidence of the endometrial safety of tibolone compared with estrogen and progestogen. Screening endometrial histology shows a low prevalence of endometrial hyperplasia (0.18%) and no carcinoma.
| Original language | English |
|---|---|
| Pages (from-to) | 866-878 |
| Number of pages | 13 |
| Journal | Fertility and Sterility |
| Volume | 88 |
| Issue number | 4 |
| DOIs | |
| State | Published - Oct 2007 |
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All Science Journal Classification (ASJC) codes
- Obstetrics and Gynecology
Cite this
Tibolone histology of the endometrium and breast endpoints study : design of the trial and endometrial histology at baseline in postmenopausal women. / Archer, David F.; Hendrix, Susan; Ferenczy, Alex; Felix, Juan; Gallagher, John Christopher G.; Rymer, Janice; Skouby, Sven O.; den Hollander, Wil; Stathopoulos, Victoria; Helmond, Frans A.
In: Fertility and Sterility, Vol. 88, No. 4, 10.2007, p. 866-878.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Tibolone histology of the endometrium and breast endpoints study
T2 - design of the trial and endometrial histology at baseline in postmenopausal women
AU - Archer, David F.
AU - Hendrix, Susan
AU - Ferenczy, Alex
AU - Felix, Juan
AU - Gallagher, John Christopher G.
AU - Rymer, Janice
AU - Skouby, Sven O.
AU - den Hollander, Wil
AU - Stathopoulos, Victoria
AU - Helmond, Frans A.
PY - 2007/10
Y1 - 2007/10
N2 - Objective: To address the endometrial safety of tibolone. Design: The Tibolone Histology of the Endometrium and Breast Endpoints Study (THEBES) is a randomized, double-blind, parallel-group trial of tibolone compared with continuous combined conjugated equine estrogen (CEE) and medroxyprogesterone acetate (MPA). Setting: Multi-country, multi-center ambulatory care setting. Patient(s): A total of 5,185 subjects were screened, and biopsies were obtained from 4,446 women. Intervention(s): Participants were randomized in a 1:1:2 ratio, to tibolone (1.25 or 2.5 mg/d) or CEE-MPA. Main Outcome Measure(s): The one-sided 95% confidence intervals for the incidence of hyperplasia or cancer were evaluated for tibolone compared with CEE-MPA. Result(s): Endometrial biopsy results at baseline: atrophic (87.29%), inactive (0.25%), proliferative (6.12%), secretory (2.86%), menstrual type (0.40%), and hyperplasia (0.18%). Only subjects with atrophic or inactive endometrium were eligible for this study, and 3% of the women at screening either had no tissue (0.18%) or had an amount of tissue that was insufficient for diagnosis (2.72%). Three thousand two hundred forty postmenopausal women with a mean (±SD) age of 54.4 ± 4.4 years and a mean time since menopause of 4.5 ± 3.6 years were randomized. Conclusion(s): The Tibolone Histology of the Endometrium and Breast Endpoints Study is a prospective, randomized clinical trial, designed to provide evidence of the endometrial safety of tibolone compared with estrogen and progestogen. Screening endometrial histology shows a low prevalence of endometrial hyperplasia (0.18%) and no carcinoma.
AB - Objective: To address the endometrial safety of tibolone. Design: The Tibolone Histology of the Endometrium and Breast Endpoints Study (THEBES) is a randomized, double-blind, parallel-group trial of tibolone compared with continuous combined conjugated equine estrogen (CEE) and medroxyprogesterone acetate (MPA). Setting: Multi-country, multi-center ambulatory care setting. Patient(s): A total of 5,185 subjects were screened, and biopsies were obtained from 4,446 women. Intervention(s): Participants were randomized in a 1:1:2 ratio, to tibolone (1.25 or 2.5 mg/d) or CEE-MPA. Main Outcome Measure(s): The one-sided 95% confidence intervals for the incidence of hyperplasia or cancer were evaluated for tibolone compared with CEE-MPA. Result(s): Endometrial biopsy results at baseline: atrophic (87.29%), inactive (0.25%), proliferative (6.12%), secretory (2.86%), menstrual type (0.40%), and hyperplasia (0.18%). Only subjects with atrophic or inactive endometrium were eligible for this study, and 3% of the women at screening either had no tissue (0.18%) or had an amount of tissue that was insufficient for diagnosis (2.72%). Three thousand two hundred forty postmenopausal women with a mean (±SD) age of 54.4 ± 4.4 years and a mean time since menopause of 4.5 ± 3.6 years were randomized. Conclusion(s): The Tibolone Histology of the Endometrium and Breast Endpoints Study is a prospective, randomized clinical trial, designed to provide evidence of the endometrial safety of tibolone compared with estrogen and progestogen. Screening endometrial histology shows a low prevalence of endometrial hyperplasia (0.18%) and no carcinoma.
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U2 - 10.1016/j.fertnstert.2006.12.052
DO - 10.1016/j.fertnstert.2006.12.052
M3 - Article
VL - 88
SP - 866
EP - 878
JO - Fertility and Sterility
JF - Fertility and Sterility
SN - 0015-0282
IS - 4
ER -