NCT00745108

Tibolone Endometrium Study (Study 32972)(P06470)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Postmenopausal Women

Interventions

Type	Name	Description
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

Timeline

• Start date: 2001-10-01
• Primary completion: 2005-07-21
• Completion: 2005-07-21
• First posted: 2008-09-03
• Last updated: 2022-02-03