Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy (Nanoparticle)

May 21, 2016 updated by: MARCO BOTELHO, University Potiguar

Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy: Effects on Blood Pressure, Insulin and C-reactive Protein and in Postmenopausal Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

185

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
      • Sao Paulo, Brazil, 04023-062
        • Marco Botelho
    • CE
      • Fortaleza, CE, Brazil, 60115-191
        • Gynelogical Center
    • RN
      • Natal, RN, Brazil, 59060
        • University Potiguar

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

42 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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;

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: NANOPARTICULATE estradiol+ progesterone

The Blood samples are 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 nanostructured estradiol and progesterone is prescribed.

The patients are evaluated 3 months after THRT treatment protocol. All the patients were instructed about how to use the pump for transdermal application, the first application is 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: Nanoparticulate estradiol + progesterone
Administration of nanoparticulate estradiol + progesterone daily by a metered-dose pump during 12 weeks in postmenopausal women with no clinical evidence of cardiovascular disease.
Other Names:
  • NANO Group
ACTIVE_COMPARATOR: MICRONIZED estradiol+ progesterone

The Blood samples are 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 micronized estradiol and progesterone is prescribed.

The patients are evaluated 3 months after THRT treatment protocol. All the patients were instructed about how to use the pump for transdermal application, the first application is 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: Micronized estradiol + progesterone
Administration of micronized estradiol + progesterone daily by a metered-dose pump during 12 weeks in postmenopausal women with no clinical evidence of cardiovascular disease.
Other Names:
  • Mic Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood Pressure variation
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
C-reactive protein levels after treatment
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Sponsor

University Potiguar

Collaborators

Federal University of São Paulo
InBios International, Inc.

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

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, 2012

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

June 7, 2015

First Submitted That Met QC Criteria

June 9, 2015

First Posted (ESTIMATE)

June 10, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

May 24, 2016

Last Update Submitted That Met QC Criteria

May 21, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Evidence/Unifesp

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.

Clinical Trials on Menopausal Syndrome

Clinical Trials on Nanoparticulate estradiol + progesterone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe