drugset / Trial / NCT01432028
Pharmacogenetic Study of Different Hormone Therapies in Recent Menopause Women
Completed
90 enrolled
Denusa Wiltgen
Conselho Nacional de Desenvolvimento Científico e Tecnológico · collabCoordenação de Aperfeiçoamento de Pessoal de Nível Superior. · collabHospital de Clinicas de Porto Alegre · collab
RandomizedCrossoverOpen-labelTreatment
Summary
This is cross-over, randomized clinical trial, with objective to evaluate the effects of low-dose oral hormone therapy and non-oral hormone therapy on endothelial function markers (fibrinogen, von Willebrand factor, c-reactive protein), natriuretic peptide and on anthropometric, metabolic and hormonal variables in early and healthy postmenopausal women and analyzing polymorphisms in the estrogen receptor gene and FTO polymorphisms Patients will be randomized to receive oral hormone treatment or non-oral hormone treatment The investigators hypothesis is that a different genotypes in the receptor estrogen gene and FTO may have an influences on treatment response in metabolic markers and cardiovascular risk
Timeline
- Start
- 2007-03
- Primary completion
- 2011-04
- Completion
- 2011-04
Publications
- Casanova G, dos Reis AM, Spritzer PM. Low-dose oral or non-oral hormone therapy: effects on C-reactive protein and atrial natriuretic peptide in menopause. Climacteric. 2015 Feb;18(1):86-93. doi: 10.3109/13697137.2014.940309. Epub 2014 Oct 21.
- Casanova G, Spritzer PM. Effects of micronized progesterone added to non-oral estradiol on lipids and cardiovascular risk factors in early postmenopause: a clinical trial. Lipids Health Dis. 2012 Oct 9;11:133. doi: 10.1186/1476-511X-11-133.
- Ramos RB, Casanova GK, Spritzer PM. Fat mass and obesity-associated gene polymorphisms do not affect metabolic response to hormone therapy in healthy postmenopausal women. Eur J Obstet Gynecol Reprod Biol. 2012 Dec;165(2):302-6. doi: 10.1016/j.ejogrb.2012.07.024. Epub 2012 Aug 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Estradiol | Other / unclassified | 1 mg | Intranasal |
| Comparator | Estradiol | Other / unclassified | 1.5 mg | Intranasal |
| Comparator | Estradiol | Other / unclassified | 3 mg | Intranasal |
| Comparator | Progesterone | Other / unclassified | 200 mg | Other |
| Comparator | drospirenone | Unknown | 2 mg | Oral |
Indications
No indication recorded.