Trial to Compare the Effects of Tibolone (Livial®) and Continuous Combined Low-Dose Estradiol/Nor… (NCT00431093) | Clinical Trial Compass
CompletedPhase 4
Trial to Compare the Effects of Tibolone (Livial®) and Continuous Combined Low-Dose Estradiol/Noresterone (Activelle®)
570 participantsStarted 2002-11
Plain-language summary
The present trial is undertaken to compare the effects of Tibolone with a low-dose HRT regimen.
Who can participate
Age range45 Years – 64 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects must be healthy and postmenopausal women, \>= 45 and \< 65 years of age, with an intact uterus.
* Subjects must have been postmenopausal for less than 15 years.
* Body Mass Index \>18 and =\< 32 kg/m2.
* Voluntary written informed consent is required.
Exclusion Criteria:
* Any unexplained abnormal uterine bleeding after the menopause.
* Double layer endometrial thickness = 6 mm as assessed by transvaginal ultrasonography.
* Treatment with oral estrogen and/or progestogen therapy within 4 weeks prior to screening, or treatment with transdermal therapy and local estrogen applications within 4 weeks prior to screening.
* Any previous or current unopposed estrogen administration, prior use of estrogen pellets or tamoxifen citrate (occasional use of estrogen-containing vaginal cream is allowed after the appropriate wash-out period is completed). Estrogen combined with sequential administration of progestogen should have been at least 10 days per 28 day cycle.
* The following wash-out periods apply:
* 4 weeks for transdermal hormonal treatment, local estrogen applications or other non-hormonal medication known to act on the relief of vasomotor symptoms (e.g. clonidine)
* 4 weeks for phytoestrogens, tibolone, intra-uterine or oral progestogen and oral estrogen/progestogen therapy
* 6 months for progestogen implants or injections and estrogen/progestogen injectable therapy.
* Any subjects who are either using phytoestrogens, tibolone, intra-ut…
What they're measuring
1
For the bleeding evaluation, subject will be given a diary card to record the days on which no bleeding, vaginal spotting or bleeding occurs
Timeframe: starting from baseline and during the whole trial period.