Tibolone Endometrium Study (Study 32972)(P06470)

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 21, 2005

Interventions

  • 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
  • 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

Arms, Groups and Cohorts

  • Experimental: Tibolone 1.25 mg
  • Experimental: Tibolone 2.5 mg
  • Active Comparator: CE/MPA

Clinical Trial Outcome Measures

Primary Measures

  • Endometrial biopsy and histological examination
    • Time Frame: At 1 year and 2 year.

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 45 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme Corp.
  • Provider of Information About this Clinical Study
    • Sponsor

References

Archer DF, Hendrix S, Ferenczy A, Felix J, Gallagher JC, Rymer J, Skouby SO, den Hollander W, Stathopoulos V, Helmond FA; THEBES Study Group. Tibolone histology of the endometrium and breast endpoints study: design of the trial and endometrial histology at baseline in postmenopausal women. Fertil Steril. 2007 Oct;88(4):866-78. Epub 2007 Jun 4.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.