Clinical trial NCT02033512: TRANSDERMAL HRT RELIEVING POSTMENOPAUSAL SYMPTOMS
Official title: NANOSTRUCTURED TRANSDERMAL HORMONE REPLACEMENT THERAPY RELIEVING MENOPAUSAL SYMPTOMS: A CONFOCAL RAMAN SPECTROSCOPY STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Menopause
Keywords: Post-menopause
Hormone Replacement Therapy
Nanotechnology
Biolipid B2
Lead sponsor: University Potiguar
Sponsor class: OTHER
Collaborators: name: Universidade Federal de Sergipe
First posted: 2014-01-10
Enrollment: 66
Sex: FEMALE
Minimum age (years): 51
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 1) last menstrual period between 6 months and 3 years before the beginning of the study plus follicle-stimulating hormone (FSH) levels higher than 35 IU/L; 2) age between 51 and 70 years; 3) no use of any medication known to interfere with hormonal levels in the past 6 months.

Exclusion Criteria:

* Patients presenting diabetes, previous hysterectomy, endometrial thickness higher than 5 mm, history of cancer, thromboembolism or established cardio vascular disease were excluded.

Primary outcomes:
measure: Estradiol Levels
timeFrame: 5 years
Secondary outcomes:
measure: Effect of Progesterone (10%) associated with Estriol (0.1) +Estradiol (0.25%) Nanoparticles formulation on postmenopausal complaints
timeFrame: 5 years
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Gynelogical Center
state: CE
Study officials:
affiliation: University Potiguar
name: MARCO A BOTELHO, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Health
name: Dinalva B Queiroz, MsC
role: STUDY_CHAIR
References:
citation: Botelho MA, Queiroz DB, Barros G, Guerreiro S, Fechine P, Umbelino S, Lyra A, Borges B, Freitas A, Queiroz DC, Ruela R, Almeida JG, Quintans L Jr. Nanostructured transdermal hormone replacement therapy for relieving menopausal symptoms: a confocal Raman spectroscopy study. Clinics (Sao Paulo). 2014 Feb;69(2):75-82. doi: 10.6061/clinics/2014(02)01.