NCT00431093

Trial to Compare the Effects of Tibolone (Livial®) and Continuous Combined Low-Dose Estradiol/Noresterone (Activelle®)

A Multicenter, Randomized, Double-Blind, Double Dummy, Group-Comparative Trial to Compare the Effects of Livial® and Activelle ® on the Vaginal Bleeding Pattern, Vasomotor Complaints, Vaginal Atrophy, QoL and Sexual Function

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 570 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 45 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The present trial is undertaken to compare the effects of Tibolone with a low-dose HRT regimen.

Conditions

• Menopause

Interventions

Type	Name	Description
DRUG	tibolone	uncoded tablets, at a dose of 2.5 mg per tablet; Subjects were to take 1 Livialâ tablet and 1 -matched Activelleâ placebo tablet, orally, once a day (preferably at the same time).
DRUG	low-dose estradiol/noresterone	Activelleâ, estradiol (E2) 1 mg and norethisterone acetate (NETA) 0.5 mg per tablet, was supplied as uncoded tablets. Subjects were to take 1 Activelleâ tablet and 1 Livialâ-matched placebo tablet, orally, once a day (preferably at the same time).

Timeline

• Start date: 2002-11-01
• Primary completion: 2005-03-01
• Completion: 2005-03-01
• First posted: 2007-02-05
• Last updated: 2022-02-03