Tibolone Endometrium Study (Study 32972)(P06470)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-01

Study Completion Date

2005-07-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Postmenopausal Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tibolone 1.25 mg

Group Type EXPERIMENTAL

tibolone

Intervention Type DRUG

oral 1.25 mg tablet, once daily, for 2 years

Tibolone 2.5 mg

Group Type EXPERIMENTAL

Tibolone 2.5 mg

Intervention Type DRUG

oral 2.5 mg tablet, once daily, for 2 years

CE/MPA

Group Type ACTIVE_COMPARATOR

CE/MPA

Intervention Type DRUG

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

Interventions

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tibolone

oral 1.25 mg tablet, once daily, for 2 years

Intervention Type DRUG

Tibolone 2.5 mg

oral 2.5 mg tablet, once daily, for 2 years

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Livial Premarin Provera

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes