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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 History of Changes |
Health Authority: | Norway: Norwegian Medicines Agency |
Estrogens Antineoplastic Agents, Hormonal Contraceptive Agents Benzoates Hormone Antagonists Contraceptives, Oral Estradiol valerate Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Cardiovascular Agents Estradiol 17 beta-cypionate Antihypertensive Agents |
Hormones Estradiol Estrogen Receptor Modulators Anabolic Agents Androgen Antagonists Tibolone Norethindrone Estradiol 3-benzoate Polyestradiol phosphate Norethindrone acetate Androgens |
Contraceptive Agents Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Estradiol valerate Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Estradiol 17 beta-cypionate Reproductive Control Agents Hormones Estrogen Receptor Modulators Tibolone Norethindrone |
Estradiol 3-benzoate Therapeutic Uses Contraceptives, Oral, Synthetic Polyestradiol phosphate Estrogens Antineoplastic Agents, Hormonal Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Estradiol Anabolic Agents Androgen Antagonists Norethindrone acetate |