Menopause
Conditions
Brief summary
The present trial is undertaken to compare the effects of Tibolone with a low-dose HRT regimen.
Interventions
DRUGtibolone
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).
DRUGlow-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).
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 64 Years
Healthy volunteers
No
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-uterine or oral progestogen, progestogen implants or injections, estrogen/progestogen combination therapy or any other non-hormonal medication known to act on the relief of vasomotor symptoms and who have not observed the appropriate wash-out periods (see previous
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For the bleeding evaluation, subject will be given a diary card to record the days on which no bleeding, vaginal spotting or bleeding occurs | starting from baseline and during the whole trial period. |
Secondary
| Measure | Time frame |
|---|---|
| Hot flushes recorded on a daily diary card during the whole trial period. | Entire trial |
| A mammography to assess breast density and blood samples to determine the changes in endocrine parameters. | screening and week 48 |
| A vaginal smear to assess the Vaginal Maturation Index and the Karyopycnotic Index results | Baseline and week 48 |
| Urogenital complaints assessed with the Local Urogenital Complaints Rating Scale. | At baseline, week 12, week 24 and week 48 |
| 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 | At baseline and week 48 |
Outcome results
None listed