Tibolone Endometrium Study (Study 32972)(COMPLETED) (THEBES)

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00745108

First received: September 2, 2008

Last updated: October 2, 2009

Last verified: October 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	September 2, 2008
Last Updated Date	October 2, 2009
Start Date ^ICMJE	October 2001
Primary Completion Date	July 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 2, 2008)	Endometrial biopsy and histological examination [ Time Frame: At 1 year and 2 year. ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00745108 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 2, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Tibolone Endometrium Study (Study 32972)(COMPLETED)
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Condition ^ICMJE	Postmenopausal Women
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	32
Completion Date	July 2005
Primary Completion Date	July 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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	Female
Ages	45 Years to 65 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00745108
Other Study ID Numbers ^ICMJE	32972
Has Data Monitoring Committee	Yes
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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