NCT00413764

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

A Multicenter, Randomized, Double-Blind, Double Dummy Trial to Compare the Effects Tibolone and Transdermal Continuous Combined Estradiol/Norethisterone on Sexual Desire and Arousal in Postmenopausal Women With Sexual Dysfunction

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 358 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 48 Years – 68 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sexual Dysfunction

Interventions

Type	Name	Description
DRUG	tibolone	tibolone (2.5 mg) over 24 weeks
DRUG	estradiol-norethisterone	transdermal continuous combined E2-NETA (estradiol-norethisterone 50/140 mcg) over 24 weeks

Timeline

• Start date: 2004-03-23
• Primary completion: 2005-11-15
• Completion: 2005-11-15
• First posted: 2006-12-20
• Last updated: 2022-02-04