TRANSDERMAL HRT RELIEVING POSTMENOPAUSAL SYMPTOMS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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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

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Menopause

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Biolipideo/B2® Biolipid/B2, Biolipideo/B2, Evidence Soluções Farmaêuticas Biolipid/B2®

Eligibility Criteria

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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.

Minimum Eligible Age

51 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes