Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy (Nanoparticle)

University Potiguar

Status and phase: Completed; Phase 2

Conditions: Menopausal Syndrome

Treatments: Drug: Nanoparticulate estradiol + progesterone; Drug: Micronized estradiol + progesterone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02467673

Evidence/Unifesp

Details and patient eligibility

About

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.

Full 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.

Enrollment: 185 patients

Sex: Female

Ages: 42 to 75 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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185 participants in 2 patient groups

NANOPARTICULATE estradiol+ progesterone

Active Comparator group

Description:

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.

Treatment:

Drug: Nanoparticulate estradiol + progesterone

MICRONIZED estradiol+ progesterone

Active Comparator group

Description:

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.

Treatment:

Drug: Micronized estradiol + progesterone