Nanoparticle: Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy

Sponsor

University Potiguar (Other)

Overall Status

Completed

CT.gov ID

NCT02467673

Collaborator

InBios International, Inc. (Industry), Federal University of São Paulo (Other)

185

Enrollment

Locations

Arms

Duration (Months)

61.7

Patients Per Site

10.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menopausal Syndrome	Drug: Micronized estradiol + progesterone Drug: Nanoparticulate estradiol + progesterone	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

185 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Blood Pressure variation [12 weeks]

Secondary Outcome Measures

C-reactive protein levels after treatment [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

42 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gynelogical Center	Fortaleza	CE	Brazil	60115-191
2	University Potiguar	Natal	RN	Brazil	59060
3	Marco Botelho	Sao Paulo		Brazil	04023-062

Sponsors and Collaborators

University Potiguar
InBios International, Inc.
Federal University of São Paulo

Investigators

Study Director: Ivaldo Silva, PHD, Federal University of São Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

MARCO BOTELHO, PhD, University Potiguar

ClinicalTrials.gov Identifier:

NCT02467673

Other Study ID Numbers:

Evidence/Unifesp

First Posted:

Jun 10, 2015

Last Update Posted:

May 24, 2016

Last Verified:

May 1, 2016

Additional relevant MeSH terms:

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Estradiol

Polyestradiol phosphate

Progesterone

Study Results

No Results Posted as of May 24, 2016