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

NCT00431093 ↗

Phase 4 Completed 570 enrolled Organon and Co

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start: 2002-11
Primary completion: 2005-03
Completion: 2005-03

Outcome

Met primary endpoint

paper The incidence of bleeding was significantly lower in the tibolone group during the first 3 months of treatment (18.3 versus 33.1%; P < 0.001) PMID 17995496 ↗

Publications

Hammar ML, van de Weijer P, Franke HR, Pornel B, von Mauw EM, Nijland EA; TOTAL Study Investigators Group. Tibolone and low-dose continuous combined hormone treatment: vaginal bleeding pattern, efficacy and tolerability. BJOG. 2007 Dec;114(12):1522-9. doi: 10.1111/j.1471-0528.2007.01537.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Estradiol	Other / unclassified	1 mg	Oral
Subject	Norethindrone	Unknown	0.5 mg	Oral
Comparator	Tibolone	Other / unclassified	2.5 mg	Oral

Indications

No indication recorded.