Pharmacogenetic Study of Different Hormone Therapies in Recent Menopause Women

NCT01432028 | Completed

• 1 other identifier: 05053
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Postmenopause

Outcome Measures

Primary Outcomes (1)

• Polymorphisms of estrogen receptor

  Influence of 4 polymorphisms (PVUII, ALUI, RSAI and BSTUI) on the effect of different treatment regimens. Change from Baseline in weight, waist circumference, BMI, systolic and diastolic blood pressure, fasting glucose, glucose at 120 min, Fasting insulin, HOMA, Cholesterol, HDL-c, LDL-c, Triglycerides, Von Willebrand Factor, Fibrinogen, Testosterone and C-reactive protein at six months.

  six months

Secondary Outcomes (1)

• Polymorphisms in the fat mass-and obesity-associated (FTO) gene

  Six Months

Other Outcomes (1)

• Effects of hormone therapy on C reactive protein, atrial natriuretic peptide and cardiovascular risk factors in postmenopause.

  Six months

Study Arms (2)

Non-oral hormone therapy

ACTIVE COMPARATOR

3 mg/day intranasal estradiol daily or 1,5 mg/day transdermal estradiol and 200 mg/day vaginal micronized progesterone for 14 days/month

Drug: Estradiol and Progesterone

oral homone therapy

ACTIVE COMPARATOR

estradiol 1mg and drospirenone 2 mg/day

Drug: Estradiol and Drospirenone

Interventions

Estradiol and Progesterone DRUG

3 mg/day intranasal estradiol daily or 1,5 mg/day transdermal estradiol and 200 mg/day vaginal micronized progesterone for 14 days/month

Non-oral hormone therapy

Estradiol and Drospirenone DRUG

oral estradiol 1mg and drospirenone 2 mg/day

oral homone therapy

Eligibility Criteria

• Age: 42 Years - 58 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• last menstrual period between 6 months and 3 years before the beginning of the study plus FSH levels higher than 35 IU/L;
• age between 42 and 58 years;
• no use of any medication known to interfere with hormonal, glucose, or lipoprotein levels in the past 3 months;
• no use of steroidal or no steroidal anti-inflammatory drugs in the last 15 days.

You may not qualify if:

• patients with diabetes,
• previous hysterectomy,
• endometrial thickness \>0.5cm,
• history of cancer,
• thromboembolism, or
• established cardiovascular disease

Sponsors & Collaborators

• Denusa Wiltgen: lead
• Hospital de Clinicas de Porto Alegre: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (3)

• 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.

  PMID: 25017924 DERIVED

• 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.

  PMID: 23046709 DERIVED

• 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.

  PMID: 22901973 DERIVED

MeSH Terms

Interventions

Estradiol; Progesterone; drospirenone

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnenediones; Pregnenes; Pregnanes; Corpus Luteum Hormones; Progesterone Congeners

Study Officials

• Poli Mara Spritzer, MD, PhD

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: April 19, 2011
• First Posted: September 12, 2011
• Study Start: March 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: January 27, 2014

Record last verified: 2014-01

Locations

BR (1)