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, J. Chris
AU - Rymer, Janice
AU - Skouby, Sven O.
AU - den Hollander, Wil
AU - Stathopoulos, Victoria
AU - Helmond, Frans A.
N1 - Funding Information:
The THEBES study was supported by NV Organon (Oss, the Netherlands; protocol 32972). NV Organon funded the study, contributed to its design, oversaw quality control at the clinical centers including periodic site visits, and validated the data collected by the centers. The sponsor did not have access to the blinding code, and played no role in collecting or adjudicating disease outcomes. The first draft of the manuscript has been prepared by an independent medical writing group. D.F.A., S.H., A.F., J.C.G., J.R., and S.O.S. are consultants and have received lecture fees and grant support from Organon. J.F. has a contractual relationship with Organon for this study. W.d.H., V.S., and F.A.H. are employees of Organon.
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
C2 - 17548089
AN - SCOPUS:34848917549
VL - 88
SP - 866
EP - 878
JO - Fertility and Sterility
JF - Fertility and Sterility
SN - 0015-0282
IS - 4
ER -