TRANSDERMAL HRT RELIEVING POSTMENOPAUSAL SYMPTOMS (THRT)

January 9, 2014 updated by: MARCO BOTELHO, University Potiguar

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • CE
      • Fortaleza, CE, Brazil, 60115-191
        • Gynelogical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estradiol Levels
Time Frame: 5 years

Effect of Progesterone (10%) associated with Estriol (0.1) +Estradiol (0.25%) Nanoparticles formulation on Estradiol serum levels

The serum levels of estradiol, over the 60 months of THRT are shown in Figure 8. Statistical analysis of mean Estradiol pretreatment values at baseline was 28.88 ± 39.62 (pg/mL) and after 60 months of THRT showed a significant increase to 51.85 ± 77.50. The data reached a statistical difference (p<0.05) after the treatment with the transdermal formulation.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Progesterone (10%) associated with Estriol (0.1) +Estradiol (0.25%) Nanoparticles formulation on postmenopausal complaints
Time Frame: 5 years
The postmenopausal symptomatology analysis of the volunteers subjected to THRT that received the nanoformulation revealed a significant decreasing of postmenopausal scores complaints (Figure 3). These values were statistically significant (P < 0.05), when the mean values from baseline were compared after 60 months of treatment. The extent of satisfaction with the hormone therapy was ~75%. The continuation induced further increases in the extent of satisfaction: 85.2 after one year and 92.5 ± 4.2% at the end of study (P < 0.05).
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Potiguar

Collaborators

Universidade Federal de Sergipe

Investigators

  • Principal Investigator: MARCO A BOTELHO, PhD, University Potiguar
  • Study Chair: Dinalva B Queiroz, MsC, School of Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (ACTUAL)

January 1, 2004

Study Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

January 9, 2014

First Posted (ESTIMATE)

January 10, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNPQ202316
  • CNPq (Other Grant/Funding Number: CNPq480010/2007-2)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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