NCT01553773

Brief Summary

The aim of this trial was to compare the effects of estradiol or genistein treatment on the hialuronic acid concentration on the postmenopausal facial skin. In this study, 30 postmenopausal women were evaluated through a prospective, randomized, double-blind trial. The volunteers were postmenopausal women treated in the Gynecology Department of the Federal University of São Paulo (UNIFESP). The participants were divided into two groups: group E, treated with 17 β estradiol gel 0.01% (n = 15), and group G, treated with genistein gel 4 % (isoflavones, n=15). The length of treatment was 24 consecutive weeks. Preauricular skin biopsies were performed on each patient before and after the treatment for evaluating hyaluronic acid in the tissue. The materials were processed through immunohistochemical and biochemical methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2004

Shorter than P25 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

July 1, 2004

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
Last Updated

March 14, 2012

Status Verified

March 1, 2012

Enrollment Period

8 months

First QC Date

March 5, 2012

Last Update Submit

March 13, 2012

Conditions

Atrophy

Keywords

Hyaluroic acidEstradiolIsoflavoneSkinPostmenopause

Outcome Measures

Primary Outcomes (1)

  • Analysis of hyaluronic acid concentration in postmenopausal facial skin

    A number two small punch biopsy of facial skin from the preauricular area was performed before and after the 24-week gel treatment.

    up to 6 months

Study Arms (2)

Isoflavone

EXPERIMENTAL

a gel with isoflavones (genistein 4%)

Drug: isoflavone

Estradiol

EXPERIMENTAL

gel with 17-β estradiol 0.01%

Drug: Estradiol

Interventions

isoflavoneDRUG

treatments: a gel with 17-β estradiol 0.01% (n = 15) and a gel with isoflavones (genistein 4%). The gels were applied once per day. the lenght of treatment was 24 weeks.

Also known as: Group G
Isoflavone
EstradiolDRUG

a gel with 17-β estradiol 0.01%. Once per day. The lenght of treatment was 24 weeks.

Also known as: Group E
Estradiol

Eligibility Criteria

Age45 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • two to five years postmenopause;
  • FSH \> 40 mU/ml;
  • estrogen levels \< 20 pg/ml;
  • body mass index (BMI) \< 30 kg/m2

You may not qualify if:

  • treatment with estrogens or soybeans for the previous 12 months;
  • tobacco user;
  • women who had a contraindication for hormone therapy, who had been using retinoids or herbal substances, and those who had a history of collagen diseases.
  • also, strict vegetarianism, high fiber- or high soy-diet consumption;
  • regular consumption of vitamin and mineral supplementation greater than the Recommended Dietary Allowances;
  • antibiotic treatment;
  • a history of chronic disorders, including endocrine or gynecological diseases or neoplasia, as well as benign breast disease; and
  • regular use of medication known to interfere with the study endpoints.
  • patients with cervico-vaginal cytology classified as Papanicolaou Class III or more were also excluded.
  • participants with hypertension who were using two or more antihypertensive drugs were not included in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gynecology - UNIFESP

São Paulo, São Paulo, 04021003, Brazil

Location

Related Publications (1)

  • Silva LA, Ferraz Carbonel AA, de Moraes ARB, Simoes RS, Sasso GRDS, Goes L, Nunes W, Simoes MJ, Patriarca MT. Collagen concentration on the facial skin of postmenopausal women after topical treatment with estradiol and genistein: a randomized double-blind controlled trial. Gynecol Endocrinol. 2017 Nov;33(11):845-848. doi: 10.1080/09513590.2017.1320708. Epub 2017 May 16.

    PMID: 28508697DERIVED

MeSH Terms

Conditions

Atrophy

Interventions

IsoflavonesEstradiol

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Marisa T Patriarca, MD, PhD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 14, 2012

Study Start

July 1, 2004

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

March 14, 2012

Record last verified: 2012-03

Locations

BR(1)