TRANSDERMAL HRT RELIEVING POSTMENOPAUSAL SYMPTOMS
Condition: Menopause
Study type: Interventional
Phase: Phase 2

Summary: 
      There is a dilemma and a permanent debate about side effects on drugs administered orally.
      The first-pass metabolism is related with many side effects, since the metabolites of these
      compounds affect the course of human physiology. Conventional hormone therapy by oral route
      has been used for relieving menopausal symptoms. Transdermal estrogens have not been used
      extensively in Brazilian women with menopausal symptomatology, however; recently a previous
      long term study has indicated no increased risk breast cancer or vasomotor disorders in
      menopausal women, using transdermal HRT.
    

Detailed description: 
      This was a prospective long-term clinical trial study of female patients aged 51-70 years old
      treated for menopause related hormone imbalances. Other results of this study are published
      elsewhere. Volunteers were recruited from referenced Gynecological Medical service where
      patient charts are maintained.

      This study is a prospective long-term clinical trial study randomized trial assessing the
      effects of Transdermal HRT on climacteric symptoms and hormone serum levels in early
      postmenopausal women. Preliminary results of this trial, including the first 42 women
      enrolled, have been published (3).

      In the present analysis, 66 women received daily in the right and left forearms a transdermal
      nanostructured formulation of Estriol (0.1%) + Estradiol (0.25%) and Progesterone (10%)
      respectively (Biolipid B2®, Evidence, SP, Brazil) for sixty months. The following were
      compared: effects of transdermal gel on baseline and after THRT were also analyzed.
    

Intervention name(s): Transdermal Hormone Replacement Therapy; Transdermal Nanoformulation; Transdermal formulation
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The Blood samples were 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 progesterone was prescribed. The patients were evaluated 3 months after THRT treatment protocol.
All the patients were instructed about how to use the progesterone pump for transdermal application, 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.; The Blood samples were 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 hormones were prescribed.; 66 patients completed the study. In the present analysis, the subjects received daily in the right and left forearm a transdermal nanostructured formulation of Estriol (0.1%) + Estradiol (0.25%) and Progesterone (10%) respectively (Biolipid B2®, Evidence, SP, Brazil) for sixty months. The effects of transdermal hormone formulation were analyzed.
Other intervention name(s): Biolipideo/B2®; Biolipid/B2, Biolipideo/B2, Evidence Soluções Farmaêuticas; Biolipid/B2®
Intervention MeSH terms: Hormones
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Post-menopause; Hormone Replacement Therapy; Nanotechnology; Biolipid B2