Efficacy of Tibolone Versus Transdermal E2/NETA on Sexual Function in Naturally Postmenopausal Women (P06089)

Summary

Tibolone has been registered for treatment of menopausal symptoms. It is, however, not known what the effects are of tibolone in postmenopausal women diagnosed with sexual dysfunction. This is important because there is currently no approved treatment of libido problems in postmenopausal women. Therefore, the primary aim of this study was to compare the effects of tibolone with an estrogen/progestogen skin patch in postmenopausal women diagnosed sexual dysfunction.

Timeline

Start

2004-03-23

Primary completion

2005-11-15

Completion

2005-11-15

Outcome

Missed primary endpoint

paper In the per protocol analysis, but not in the intent-to-treat analysis, the increase in FSFI scores was significantly larger in the tibolone group PMID 18304284 ↗

Publications

• Results Nijland EA, Weijmar Schultz WC, Nathorst-Boos J, Helmond FA, Van Lunsen RH, Palacios S, Norman RJ, Mulder RJ, Davis SR; LISA study investigators. Tibolone and transdermal E2/NETA for the treatment of female sexual dysfunction in naturally menopausal women: results of a randomized active-controlled trial. J Sex Med. 2008 Mar;5(3):646-56. doi: 10.1111/j.1743-6109.2007.00726.x.

Drugs

Indications