Trial to Compare the Effects of Tibolone (Livial®) and Continuous Combined Low-Dose Estradiol/Noresterone (Activelle®) (TOTAL)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- For the bleeding evaluation, subject will be given a diary card to record the days on which no bleeding, vaginal spotting or bleeding occurs [ Time Frame: starting from baseline and during the whole trial period. ] [ Designated as safety issue: No ]
- Hot flushes recorded on a daily diary card during the whole trial period. [ Time Frame: Entire trial ] [ Designated as safety issue: No ]
- A mammography to assess breast density and blood samples to determine the changes in endocrine parameters. [ Time Frame: screening and week 48 ] [ Designated as safety issue: No ]
- A vaginal smear to assess the Vaginal Maturation Index and the Karyopycnotic Index results [ Time Frame: Baseline and week 48 ] [ Designated as safety issue: No ]
- Urogenital complaints assessed with the Local Urogenital Complaints Rating Scale. [ Time Frame: At baseline, week 12, week 24 and week 48 ] [ Designated as safety issue: Yes ]
- Health-related quality of life measured with the Women's Health Questionnaire 36-items (WHQ-36) the McCoy Female Sexuality Questionnaire-Short Form 9-items (MFSQ-SF) collecting prospectively medical resources utilization items [ Time Frame: At baseline and week 48 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2002|
|Study Completion Date:||March 2005|
|Primary Completion Date:||March 2005 (Final data collection date for primary outcome measure)|
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).
Other Name: Activelle®
Active Comparator: 2
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).
Other Name: Livial
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