Fertility and Sterility
Volume 88, Issue 4 , Pages 866-878, October 2007

Tibolone histology of the endometrium and breast endpoints study: design of the trial and endometrial histology at baseline in postmenopausal women

  • David F. Archer, M.D.

      Affiliations

    • Department of Obstetrics and Gynecology, Contraceptive Research and Development Program Clinical Research Center, Eastern Virginia Medical School, Norfolk, Virginia
    • Corresponding Author InformationReprint requests: David F. Archer, M.D., Eastern Virginia Medical School, CONRAD Clinical Research Center, 601 Colley Avenue, Norfolk, Virginia 23507 (FAX: 757-446-8988).
    • ,
  • Susan Hendrix, D.O.

      Affiliations

    • Wayne State University/Hutzel Women's Hospital, Detroit, Michigan
    • ,
  • Alex Ferenczy, M.D.

      Affiliations

    • McGill University and Sir Mortimer B. Davis-Jewish General Hospital, Montreal, Quebec, Canada
    • ,
  • Juan Felix, M.D.

      Affiliations

    • Department of Pathology, Keck School of Medicine, University of Southern California, Los Angeles, California
    • ,
  • J. Chris Gallagher, M.D.

      Affiliations

    • Bone Metabolism Section, Creighton University Medical Center, Omaha, Nebraska
    • ,
  • Janice Rymer, M.D., Ph.D.

      Affiliations

    • King's College School of Medicine at Guy's and St. Thomas' Hospitals, Division of Obstetrics and Gynaecology, London, United Kingdom
    • ,
  • Sven O. Skouby, M.D.

      Affiliations

    • Department of Obstetrics and Gynecology, Frederiksberg Hospital, Copenhagen, Denmark
    • ,
  • Wil den Hollander, Ph.D.

      Affiliations

    • NV Organon, Oss, the Netherlands
    • ,
  • Victoria Stathopoulos, Ph.D.

      Affiliations

    • Organon International, Roseland, New Jersey
    • ,
  • Frans A. Helmond, Ph.D.

      Affiliations

    • Organon International, Roseland, New Jersey
    • ,
  • THEBES Study Group

Received 26 May 2006; received in revised form 27 December 2006; accepted 27 December 2006. published online 04 June 2007.

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 The THEBES Study Group participants are listed in the Appendix.

 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.

PII: S0015-0282(07)00098-2

doi:10.1016/j.fertnstert.2006.12.052

Fertility and Sterility
Volume 88, Issue 4 , Pages 866-878, October 2007

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