Tibolone Endometrium Study (Study 32972)(P06470) (THEBES)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00745108
First received: September 2, 2008
Last updated: May 22, 2014
Last verified: May 2014

September 2, 2008
May 22, 2014
October 2001
July 2005   (final data collection date for primary outcome measure)
Endometrial biopsy and histological examination [ Time Frame: At 1 year and 2 year. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00745108 on ClinicalTrials.gov Archive Site
Double-layer endometrial thickness by transvaginal ultrasonography (TVUS), vaginal bleeding from a Bleeding Episode Log. [ Time Frame: TVUS: at 1 year and 2 year; Vaginal bleeding: daily recording ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Tibolone Endometrium Study (Study 32972)(P06470)
A Multinational, Multicenter, Randomized, Double-blind, Parallel Group, Active Controlled, Comparative Trial, to Assess the Endometrial Histological Profile Following Treatment With Tibolone (Org OD14) Versus Conjugated Estrogen (CE) Plus Medroxyprogesterone Acetate (MPA) in Postmenopausal Women

Tibolone has been registered for the treatment of climacteric symptoms and for the prevention of postmenopausal osteoporosis. This is a 2-year study to further confirm the endometrial safety of tibolone in comparison with CE/MPA.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Postmenopausal Women
  • Drug: tibolone
    oral 1.25 mg tablet, once daily, for 2 years
  • Drug: Tibolone 2.5 mg
    oral 2.5 mg tablet, once daily, for 2 years
    Other Name: Livial
  • Drug: CE/MPA
    oral, 0.625 mg tablet conjugated equine estrogen and 2.5 mg medroxyprogesterone acetate tablet placed together in a single capsule, once daily, for 2 years
    Other Names:
    • Premarin
    • Provera
  • Experimental: Tibolone 1.25 mg
    Intervention: Drug: tibolone
  • Experimental: Tibolone 2.5 mg
    Intervention: Drug: Tibolone 2.5 mg
  • Active Comparator: CE/MPA
    Intervention: Drug: CE/MPA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
July 2005
July 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy postmenopausal women, 45 to 65 years of age with an intact uterus. Women must have been postmenopausal for less than 15 years, have an atrophic or inactive endometrium, and a body mass index of 18 - 32 kg/ m2 (inclusive).

Exclusion Criteria:

  • Final diagnosis of the endometrial biopsy as 'no tissue' or 'tissue insufficient for diagnosis'.
  • Double layer endometrial thickness > 6 mm as assessed by transvaginal ultrasonography (TVUS).
  • Any previous or current unopposed estrogen administration or tamoxifen citrate.
  • Any unexplained vaginal bleeding following the menopause.
  • Women with abnormal Pap smear test results (PAP IIb and higher)
  • Previous use of raloxifene hydrochloride for longer than one month.
Female
45 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00745108
P06470, 32972
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP