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Sponsored by: |
Organon |
Information provided by: | Organon |
ClinicalTrials.gov Identifier: | NCT00431093 |
The present trial is undertaken to compare the effects of Tibolone with a low-dose HRT regimen.
Condition | Intervention | Phase |
Menopause |
Drug: tibolone Drug: low-dose estradiol/noresterone |
Phase IV |
MedlinePlus related topics: | Menopause |
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, Group-Comparative Trial to Compare the Effects of Livial® and Activelle ® on the Vaginal Bleeding Pattern, Vasomotor Complaints, Vaginal Atrophy, QoL and Sexual Function |
Enrollment: | 570 |
Study Start Date: | November 2002 |
Study Completion Date: | March 2005 |
Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
tibolone
|
Drug: low-dose estradiol/noresterone
Activelleâ, estradiol (E2) 1 mg and norethisterone acetate (NETA) 0.5 mg per tablet, was supplied as uncoded tablets. Subjects were to take 1 Activelleâ tablet and 1 Livialâ-matched placebo tablet, orally, once a day (preferably at the same time). |
2: Active Comparator
low-dose estradiol/noresterone
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Drug: tibolone
uncoded tablets, at a dose of 2.5 mg per tablet; Subjects were to take 1 Livialâ tablet and 1 -matched Activelleâ placebo tablet, orally, once a day (preferably at the same time).
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Ages Eligible for Study: | 45 Years to 64 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The following wash-out periods apply:
History or presence of cardiovascular or cerebrovascular conditions:
Responsible Party: | NV Organon, part of Schering-Plough Corporation ( Study Director ) |
Study ID Numbers: | C-1755 |
First Received: | February 2, 2007 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00431093 |
Health Authority: | Belgium: National Board of Health |
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