Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Menopausal Syndrome

Intervention / Treatment
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* Drug: Micronized estradiol + progesterone
* Drug: Nanoparticulate estradiol + progesterone


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 42 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NANOPARTICULATE estradiol+ progesterone<br>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<br>* Administration of nanoparticulate estradiol + progesterone daily by a metered-dose pump during 12 weeks in postmenopausal women with no clinical evidence of cardiovascular disease.<br>* Other names: NANO Group;|
| Active Comparator: MICRONIZED estradiol+ progesterone<br>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<br>* Administration of micronized estradiol + progesterone daily by a metered-dose pump during 12 weeks in postmenopausal women with no clinical evidence of cardiovascular disease.<br>* Other names: Mic Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure variation |  | 12 weeks | 

Secondary Outcome Measures

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