Study Overview

Details

NCTId: NCT02467673

Status: Completed

Condition: Menopausal Syndrome

Study Type: Interventional

Sponsor: University Potiguar

Study Description

Brief

The study aims to asses the effects of micronized (MIC) and nanoparticulate (NANO) transdermal hormone therapy (THT) on blood pressure, ultra-sensitive C-reactive protein (CRP), and cardiovascular risk factors in postmenopausal women.

Detailed

In this open label study, 27 postmenopausal women, with no clinical evidence of cardiovascular disease, were randomly divided in two groups.

During 12 weeks,

15 patients received on the left forearm micronized (MIC) THT (micronized 17β-estradiol 2.5 mg/day + progesterone 100 mg/day).

and

14 patients received a nanoparticulate (NANO) THT (nanoparticulate 17β-estradiol 2.5 mg/day + progesterone 100mg/day).

After 12 weeks of treatment patients were evaluated.

Baseline and Post-THT measures were determined: Insulin, body mass index, waist circumference, blood pressure, CRP-stratified levels, total testosterone, TSH and FSH levels.

Eligibility

Criteria:

Inclusion Criteria:

A body mass index between 18 and 27 kg/m2;
Sex live complaints;
No evidence of cardiovascular disease;
General good health based on history and physical examination.

Exclusion Criteria:

A past history of neurological disorder;
Had received pharmacotherapy for cardiovascular disease before screening
Taking medication known to interfere with steroids;
Recent psychiatric or systemic illness;
Uncontrolled hypertension (blood pressure>160/95mmHg),
Unstable cardiovascular disease;
Genital bleeding;
Use of psychoactive medications,
Alcohol excess consumption or any other drug abuse;

Healthy Volunteers: Accepts Healthy Volunteers

Gender: Female

Min Age: 42 Years

Max Age: 75 Years

Contacts

Marco Botelho

Sao Paulo

RN

04023-062

Brazil