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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
358
tibolone (2.5 mg) over 24 weeks
transdermal continuous combined E2-NETA (estradiol-norethisterone 50/140 mcg) over 24 weeks
Compare the effect of tibolone (2.5 mg) to transdermal E2/NETA (50/140 mcg) on the vaginal bleeding and spotting rate in healthy postmenopausal women with sexual dysfunction.
Time frame: Week 13-24 of the in treatment period
Compare the effect of tibolone to E2/NETA on sexual functioning in healthy postmenopausal women with sexual dysfunction.
Time frame: Week 8-12 and Week 20-24 of the in-treatment period.
Compare the effects of tibolone to E2/NETA on the frequency of satisfactory sexual events, the frequency of sexual fantasies and subjective arousal, scores on the FSFI, FSDS, WHQ and endocrine parameters
Time frame: Week 8-12 and Week 20-24 of the in-treatment period
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