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Sponsored by: |
Organon |
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Information provided by: | Organon |
ClinicalTrials.gov Identifier: | NCT00413764 |
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.
Condition | Intervention | Phase |
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Sexual Dysfunction |
Drug: tibolone Drug: estradiol-norethisterone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 358 |
Study Start Date: | June 2004 |
Study Completion Date: | September 2005 |
Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
tibolone
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Drug: tibolone
tibolone (2.5 mg) over 24 weeks
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2: Active Comparator
transdermal continuous combined E2-NETA (estradiol-norethisterone)
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Drug: estradiol-norethisterone
transdermal continuous combined E2-NETA (estradiol-norethisterone 50/140 mcg) over 24 weeks
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Ages Eligible for Study: | 48 Years to 68 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | NV Organon, part of Schering-Plough Corporation ( Study Director ) |
Study ID Numbers: | C-1774 |
Study First Received: | December 19, 2006 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00413764 |
Health Authority: | Norway: Norwegian Medicines Agency |
Tibolone Benzoates Norethindrone Estradiol 3-benzoate Estradiol valerate |
Estradiol 17 beta-cypionate Polyestradiol phosphate Estradiol Norethindrone acetate |
Estrogens Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptive Agents Hormone Antagonists Physiological Effects of Drugs Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Cardiovascular Agents |
Reproductive Control Agents Antihypertensive Agents Hormones Pharmacologic Actions Estrogen Receptor Modulators Anabolic Agents Androgen Antagonists Therapeutic Uses Contraceptives, Oral, Synthetic |