Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy

Menopausal Syndrome Clinical Trial

— Nanoparticle  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467673
• Other study ID #: Evidence/Unifesp
• Status: Completed
• Phase: Phase 2
• First received: June 7, 2015
• Last updated: May 21, 2016
• Start date: January 2012
• Est. completion date: July 2012

Study information

• Verified date: May 2016
• Source: University Potiguar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: July 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 42 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopausal Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Gynelogical Center	Fortaleza	CE
Brazil	University Potiguar	Natal	RN
Brazil	Marco Botelho	Sao Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University Potiguar	Federal University of São Paulo, InBios International, Inc.

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

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 s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure variation		12 weeks	Yes
Secondary	C-reactive protein levels after treatment		12 weeks	No