Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Potiguar
• Collaborators: Federal University of São Paulo; InBios International, Inc.
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Hormones; Polyestradiol phosphate; Progesterone

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;