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OpenTrials
Completed

NCT Number: NCT02467673

Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy

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.

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Key information

Conditions

Age range

42 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Gynelogical Center, Fortaleza, Ceará, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Micronized estradiol + progesterone

Drug

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

Nanoparticulate estradiol + progesterone

Drug

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

Primary outcomes

  1. Blood Pressure variation

    Time frame: 12 weeks

Secondary outcomes

  1. C-reactive protein levels after treatment

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University Potiguar

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Nanoparticle

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 10, 2015
Registry last updated
May 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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