Tibolone Endometrium Study (Study 32972)(P06470)

Phase 3 Completed 32 enrolled Organon and Co

RandomizedParallel-groupQuadruple-blindOther

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.

Timeline

Start: 2001-10-01
Primary completion: 2005-07-21
Completion: 2005-07-21

Publications

Background Archer DF, Hendrix S, Ferenczy A, Felix J, Gallagher JC, Rymer J, Skouby SO, den Hollander W, Stathopoulos V, Helmond FA; THEBES Study Group. Tibolone histology of the endometrium and breast endpoints study: design of the trial and endometrial histology at baseline in postmenopausal women. Fertil Steril. 2007 Oct;88(4):866-78. doi: 10.1016/j.fertnstert.2006.12.052. Epub 2007 Jun 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	CE/MPA	Unknown	0.625 mg	Oral
Subject	Tibolone	Other / unclassified	1.25 mg	Oral
Subject	Tibolone	Other / unclassified	2.5 mg	Oral
Comparator	medroxyprogesterone acetate	Other / unclassified	2.5 mg	Oral

Indications

No indication recorded.