Efficacy of Tibolone Versus Transdermal E2/NETA on Sexual Function in Naturally Postmenopausal Women (P06089)
This study has been completed.
Merck Sharp & Dohme Corp.
First Posted: December 20, 2006
Last Update Posted: April 10, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
|Sexual Dysfunction||Drug: tibolone Drug: estradiol-norethisterone||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
Resource links provided by NLM:
Drug Information available for: Estradiol Norethindrone acetate Norethindrone Estradiol cypionate Estradiol valerate Estradiol acetate Estradiol hemihydrateU.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- 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. ]
Secondary Outcome Measures:
- 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 ]
|Actual Study Start Date:||March 23, 2004|
|Study Completion Date:||November 15, 2005|
|Primary Completion Date:||November 15, 2005 (Final data collection date for primary outcome measure)|
tibolone (2.5 mg) over 24 weeks
Other Name: Livial®
Active Comparator: 2
transdermal continuous combined E2-NETA (estradiol-norethisterone)
transdermal continuous combined E2-NETA (estradiol-norethisterone 50/140 mcg) over 24 weeks
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