Clinical trial NCT02467673: Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Menopausal Syndrome
Lead sponsor: University Potiguar
Sponsor class: OTHER
Collaborators: name: InBios International, Inc.
name: Federal University of São Paulo
First posted: 2015-06-10
Enrollment: 185
Sex: FEMALE
Minimum age (years): 42
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Blood Pressure variation
timeFrame: 12 weeks
Secondary outcomes:
measure: C-reactive protein levels after treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Gynelogical Center
state: CE
city: Natal
country: Brazil
facility: University Potiguar
state: RN
city: Sao Paulo
country: Brazil
facility: Marco Botelho
Study officials:
affiliation: Federal University of São Paulo
name: Ivaldo Silva, PHD
role: STUDY_DIRECTOR
References:
citation: 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.
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 spectroscopy study. Clinics (Sao Paulo). 2014 Feb;69(2):75-82. doi: 10.6061/clinics/2014(02)01.