NCT02033512

TRANSDERMAL HRT RELIEVING POSTMENOPAUSAL SYMPTOMS

NANOSTRUCTURED TRANSDERMAL HORMONE REPLACEMENT THERAPY RELIEVING MENOPAUSAL SYMPTOMS: A CONFOCAL RAMAN SPECTROSCOPY STUDY

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: University Potiguar · Academic / Other
• Sex: Female
• Age: 51 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Menopause

Interventions

Type	Name	Description
DRUG	Transdermal Hormone Replacement Therapy	The Blood samples were collected from the subjects early in the morning after an overnight fast. After serum testing, the identification hormone deficiencies, was determined and then, if necessary, additional transdermal progesterone was prescribed. The patients were evaluated 3 months after THRT treatment protocol. All the patients were instructed about how to use the progesterone pump for transdermal application, performed in the presence of an experienced physician, in order to guarantee standardization and correct use of the THRT. Compliance was defined as completing seventy percent or more of the transdermal applications.
DRUG	Transdermal Nanoformulation	The Blood samples were collected from the subjects early in the morning after an overnight fast. After serum testing, the identification hormone deficiencies, was determined and then, if necessary, additional transdermal hormones were prescribed.
DRUG	Transdermal formulation	66 patients completed the study. In the present analysis, the subjects received daily in the right and left forearm a transdermal nanostructured formulation of Estriol (0.1%) + Estradiol (0.25%) and Progesterone (10%) respectively (Biolipid B2®, Evidence, SP, Brazil) for sixty months. The effects of transdermal hormone formulation were analyzed.

Timeline

• Start date: 2003-01-01
• Primary completion: 2004-01-01
• Completion: 2008-04-01
• First posted: 2014-01-10
• Last updated: 2014-01-10

Locations

1 site across 1 country: Brazil