Étude du contrôle des symptômes climatériques chez les femmes ménopausées suite à des schémas séquentiels d'estradiol 17bêta 1 mg et de trimégestone comparés à un schéma contenant 1 mg de valérate d'estradiol et de norethindrone sur une période de deux ans.
4 Essai contrôlé de grande envergure
- Type d'étude
- essai contrôlé
- Étudié chez
- des personnes
- Participants
- 531
- Publié
- 2006 in Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology
- Cité
- 4 times by other research
- Qui a payé
- Non déclaré. PubMed ne contient pas de déclaration de conflit d'intérêts pour la plupart des articles ; ce n'est pas la même chose qu'indépendant.
- Source
- PubMed 16294458 · doi 10.1080/09513590500128815
OBJECTIVE: To compare the efficacy of two sequential 17beta-estradiol (17beta-E2)/trimegestone (TMG) combinations with the sequential estradiol valerate (E2V)/norethisterone (NET) regimen in relieving climacteric symptoms. STUDY DESIGN: This was a double-blind, randomized, multicenter study conducted among 1218 Caucasian (99%) postmenopausal women with an intact uterus in seven European countries and Israel, over 13 cycles (each of 28 days). Study duration was extended further for 13 cycles, with 531 women receiving treatment for up to 26 cycles. Treatments consisted of 1 mg 17beta-E2 on days 1-14 and 1 mg 17beta-E2/0.125 mg TMG or 0.25 mg TMG on days 15-28, and 1 mg E2V on days 1-16 and 1 mg E2V/1 mg NET on days 17-28. RESULTS: Rapid and significant reductions in the mean daily number and severity of hot flushes and in the mean daily number of nocturnal sweats were established in most women with 1 mg 17beta-E2/0.25 mg TMG and E2V/NET. These treatments also induced a significant improvement in the quality-of-life assessments. CONCLUSION: The 1 mg 17beta-E2/0.25 mg TMG regimen provides rapid and effective relief of menopausal symptoms, with a reduction in the number of hot flushes "at least as good as" that of the E2V/NET comparator.