Tibolone Endometrium Study (Study 32972)(P06470)

Organon and Co32 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Postmenopausal Women

Interventions

tiboloneDRUG

oral 1.25 mg tablet, once daily, for 2 years

Tibolone 2.5 mgDRUG

oral 2.5 mg tablet, once daily, for 2 years

CE/MPADRUG

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

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Endometrial biopsy and histological examination

Time frame: At 1 year and 2 year.

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.