TRANSDERMAL HRT RELIEVING POSTMENOPAUSAL SYMPTOMS (THRT)

University Potiguar

Status and phase

Completed

Phase 2

Conditions

Menopause

Treatments

Drug: Transdermal formulation

Drug: Transdermal Hormone Replacement Therapy

Drug: Transdermal Nanoformulation

Study type

Interventional

Funder types

Other

Identifiers

NCT02033512

CNPq (Other Grant/Funding Number)

CNPQ202316

Details and patient eligibility

About

There is a dilemma and a permanent debate about side effects on drugs administered orally. The first-pass metabolism is related with many side effects, since the metabolites of these compounds affect the course of human physiology. Conventional hormone therapy by oral route has been used for relieving menopausal symptoms. Transdermal estrogens have not been used extensively in Brazilian women with menopausal symptomatology, however; recently a previous long term study has indicated no increased risk breast cancer or vasomotor disorders in menopausal women, using transdermal HRT.

Full description

This was a prospective long-term clinical trial study of female patients aged 51-70 years old treated for menopause related hormone imbalances. Other results of this study are published elsewhere. Volunteers were recruited from referenced Gynecological Medical service where patient charts are maintained.

This study is a prospective long-term clinical trial study randomized trial assessing the effects of Transdermal HRT on climacteric symptoms and hormone serum levels in early postmenopausal women. Preliminary results of this trial, including the first 42 women enrolled, have been published (3).

In the present analysis, 66 women received daily in the right and left forearms a transdermal nanostructured formulation of Estriol (0.1%) + Estradiol (0.25%) and Progesterone (10%) respectively (Biolipid B2®, Evidence, SP, Brazil) for sixty months. The following were compared: effects of transdermal gel on baseline and after THRT were also analyzed.

Enrollment

66 patients

Sex

Female

Ages

51 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

1. last menstrual period between 6 months and 3 years before the beginning of the study plus follicle-stimulating hormone (FSH) levels higher than 35 IU/L; 2) age between 51 and 70 years; 3) no use of any medication known to interfere with hormonal levels in the past 6 months.

Exclusion criteria

Patients presenting diabetes, previous hysterectomy, endometrial thickness higher than 5 mm, history of cancer, thromboembolism or established cardio vascular disease were excluded.