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

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ClinicalTrials.gov Identifier: NCT00745108
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postmenopausal Women Drug: tibolone Drug: Tibolone 2.5 mg Drug: CE/MPA Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : October 1, 2001
Primary Completion Date : July 21, 2005
Study Completion Date : July 21, 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Tibolone 1.25 mg Drug: tibolone
oral 1.25 mg tablet, once daily, for 2 years
Experimental: Tibolone 2.5 mg Drug: Tibolone 2.5 mg
oral 2.5 mg tablet, once daily, for 2 years
Other Name: Livial
Active Comparator: CE/MPA 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



Primary Outcome Measures :
  1. Endometrial biopsy and histological examination [ Time Frame: At 1 year and 2 year. ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00745108     History of Changes
Other Study ID Numbers: P06470
32972
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Medroxyprogesterone
Medroxyprogesterone Acetate
Tibolone
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antihypertensive Agents
Estrogen Receptor Modulators
Anabolic Agents
Hormones