NCT02033512

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
Last Updated

January 10, 2014

Status Verified

January 1, 2014

Enrollment Period

1 year

First QC Date

December 10, 2013

Last Update Submit

January 9, 2014

Conditions

Menopause

Keywords

Post-menopauseHormone Replacement TherapyNanotechnologyBiolipid B2

Outcome Measures

Primary Outcomes (1)

  • Estradiol Levels

    Effect of Progesterone (10%) associated with Estriol (0.1) +Estradiol (0.25%) Nanoparticles formulation on Estradiol serum levels The serum levels of estradiol, over the 60 months of THRT are shown in Figure 8. Statistical analysis of mean Estradiol pretreatment values at baseline was 28.88 ± 39.62 (pg/mL) and after 60 months of THRT showed a significant increase to 51.85 ± 77.50. The data reached a statistical difference (p\<0.05) after the treatment with the transdermal formulation.

    5 years

Secondary Outcomes (1)

  • Effect of Progesterone (10%) associated with Estriol (0.1) +Estradiol (0.25%) Nanoparticles formulation on postmenopausal complaints

    5 years

Interventions

Transdermal Hormone Replacement TherapyDRUG

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.

Also known as: Biolipideo/B2®
Transdermal NanoformulationDRUG

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.

Also known as: Biolipid/B2, Biolipideo/B2, Evidence Soluções Farmaêuticas
Transdermal formulationDRUG

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.

Also known as: Biolipid/B2®

Eligibility Criteria

Age51 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynelogical Center

Fortaleza, Ceará, 60115-191, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 24519196DERIVED

Related Links

Study Officials

  • MARCO A BOTELHO, PhD

    University Potiguar

    PRINCIPAL INVESTIGATOR

  • Dinalva B Queiroz, MsC

    School of Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 10, 2013

First Posted

January 10, 2014

Study Start

January 1, 2003

Primary Completion

January 1, 2004

Study Completion

April 1, 2008

Last Updated

January 10, 2014

Record last verified: 2014-01

Locations

BR(1)