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Hormone Replacement Therapy on the Postmenopausal Endometrium

NCT02384408 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-10-14

No results posted yet for this study

Summary

Healthy postmenopausal women, amenorrheic for 1-10 years, aged 45-60 years and in use of follicle stimulating hormone \> 30 mille-International unit/milliliters (mIU/mL), will participate in the study.

All women will be informed by a physician of the risks and possible benefits of Hormone Replacement Therapy (HRT).

The continuous combined treatment with drospirenone 2 mg and 17β-estradiol 1 mg or tibolone 1.25 mg will be administered for a 24-week period.

Transvaginal ultrasound was performed to evaluate the thickness of the endometrium at baseline. At study end-point, an endometrial biopsy will be performed with a Pipelle endometrial sampler to examine histological and immunohistochemical parameters.

Immunohistochemical detection of Bcl-2 protein, estrogen and progesterone receptors will be performed in stroma and glandular epithelium.

Conditions

Interventions

PROCEDURE

Endometrial Biopsy

Histological assessment

DEVICE

Transvaginal Ultrasound

Endometrial Thickness made by ultrasound

PROCEDURE

Endometrial Immunohistochemical

Immunoexpression of estrogen (ER) and progesterone receptors (PR) and Bcl-2 protein

Sponsors & Collaborators

  • Faculdade de Ciências Médicas da Santa Casa de São Paulo

    collaborator OTHER

  • Universidade do Vale do Sapucai

    lead OTHER

Principal Investigators

  • Benedito F Reis, Prof · Faculdade de Ciências Médicas da Santa Casa de São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-06-30
Completion
2015-07-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02384408 on ClinicalTrials.gov