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 (TOTAL)

NCT00431093 Phase 4 COMPLETED

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

Details

Lead sponsor	Organon and Co
Phase	Phase 4
Status	COMPLETED
Enrolment	570
Start date	2002-11
Completion	2005-03

Conditions

• Menopause

Interventions

• tibolone
• low-dose estradiol/noresterone

Primary outcomes

• For the bleeding evaluation, subject will be given a diary card to record the days on which no bleeding, vaginal spotting or bleeding occurs — starting from baseline and during the whole trial period.