Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy

NCT02467673 | Completed Phase 2

• 1 other identifier: Evidence/Unifesp
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Menopausal Syndrome

Outcome Measures

Primary Outcomes (1)

• Blood Pressure variation

  12 weeks

Secondary Outcomes (1)

• C-reactive protein levels after treatment

  12 weeks

Study Arms (2)

NANOPARTICULATE estradiol+ progesterone

ACTIVE COMPARATOR

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

MICRONIZED estradiol+ progesterone

ACTIVE COMPARATOR

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

Interventions

Micronized estradiol + progesterone DRUG

Administration of micronized estradiol + progesterone daily by a metered-dose pump during 12 weeks in postmenopausal women with no clinical evidence of cardiovascular disease.

Also known as: Mic Group

MICRONIZED estradiol+ progesterone

Nanoparticulate estradiol + progesterone DRUG

Administration of nanoparticulate estradiol + progesterone daily by a metered-dose pump during 12 weeks in postmenopausal women with no clinical evidence of cardiovascular disease.

Also known as: NANO Group

NANOPARTICULATE estradiol+ progesterone

Eligibility Criteria

• Age: 42 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University Potiguar: lead
• InBios International, Inc.: collaborator
• Federal University of São Paulo: collaborator

Study Sites (3)

Gynelogical Center

Fortaleza, Ceará, 60115-191, Brazil

Location

University Potiguar

Natal, Rio Grande do Norte, 59060, Brazil

Location

Marco Botelho

São Paulo, São Paulo, 04023-062, Brazil

Location

Related Publications (2)

• Botelho MA, Martins JG, Ruela RS, Queiroz DB, Ruela WS. Nanotechnology in ligature-induced periodontitis: protective effect of a doxycycline gel with nanoparticules. J Appl Oral Sci. 2010 Jul-Aug;18(4):335-42. doi: 10.1590/s1678-77572010000400003.

  PMID: 20835566 BACKGROUND

• Botelho MA, Queiroz DB, Barros G, Guerreiro S, Fechine P, Umbelino S, Lyra A, Borges B, Freitas A, Queiroz DC, Ruela R, Almeida JG, Quintans L Jr. Nanostructured transdermal hormone replacement therapy for relieving menopausal symptoms: a confocal Raman spectroscopy study. Clinics (Sao Paulo). 2014 Feb;69(2):75-82. doi: 10.6061/clinics/2014(02)01.

  PMID: 24519196 RESULT

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Ivaldo Silva, PHD

  Federal University of São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 7, 2015
• First Posted: June 10, 2015
• Study Start: January 1, 2012
• Primary Completion: March 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 24, 2016

Record last verified: 2016-05

Locations

BR (3)