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Trial record 68 of 74 for:    estrogen replacement therapy

Hormone Replacement Therapy on the Postmenopausal Endometrium

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ClinicalTrials.gov Identifier: NCT02384408
Recruitment Status : Completed
First Posted : March 10, 2015
Last Update Posted : October 14, 2015
Sponsor:
Collaborator:
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Information provided by (Responsible Party):
Benedito Fabiano dos Reis, Universidade do Vale do Sapucai

Brief 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.


Condition or disease Intervention/treatment Phase
Menopause Procedure: Endometrial Biopsy Device: Transvaginal Ultrasound Procedure: Endometrial Immunohistochemical Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparative Effects of Drospirenone and Tibolone on the Postmenopausal Endometrium
Study Start Date : November 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
Control Group: Women without hormone replacement therapy. Transvaginal Ultrasound - Endometrial Thickness; Endometrial Biopsy. Endometrial Immunohistochemical Study
Procedure: Endometrial Biopsy
Histological assessment

Device: Transvaginal Ultrasound
Endometrial Thickness made by ultrasound
Other Name: Endometrial Thickness

Procedure: Endometrial Immunohistochemical
Immunoexpression of estrogen (ER) and progesterone receptors (PR) and Bcl-2 protein

Experimental: Hormone treatment

Group Drospirenone: To whom a continuous combined treatment with drospirenone 2 mg and 17β-estradiol 1 mg (DRSP/E2) will be administered daily for 24 weeks.

Group Tibolone: To whom treatment with tibolone 1.25 mg (Tib) will be administered daily for 24 weeks.

Transvaginal Ultrasound - Endometrial Thickness; Endometrial Biopsy. Endometrial Immunohistochemical Study

Procedure: Endometrial Biopsy
Histological assessment

Device: Transvaginal Ultrasound
Endometrial Thickness made by ultrasound
Other Name: Endometrial Thickness

Procedure: Endometrial Immunohistochemical
Immunoexpression of estrogen (ER) and progesterone receptors (PR) and Bcl-2 protein




Primary Outcome Measures :
  1. The endometrium thickness [ Time Frame: up to 24 weeks ]
    Transvaginal ultrasound will be performed to evaluate the thickness of the endometrium in milimiters at baseline and the end of the study in postmenopausal women under use of drospirenone and tibolone. The results will be expressed as mean and standard deviation.


Secondary Outcome Measures :
  1. Bcl-2 protein in postmenopausal endometrium [ Time Frame: 24 weeks ]
    Histological and immunohistochemical detection of Bcl-2 protein will be performed on postmenopausal endometrium. The cell count will be expressed as numerical density, i.e. number of positive cells per square millimeter of epithelium.

  2. Estrogen and progestogen receptors in postmenopausal endometrium [ Time Frame: 24 weeks ]
    The presence of estrogen and progestogen receptors will be performed on postmenopausal endometrium. The cell count will be expressed as numerical density, i.e. number of positive cells per square millimeter of epithelium.



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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy postmenopausal women, amenorrheic for 1-10 years,
  • aged 45-60 years and in use of follicle stimulating hormone > 30 mIU/mL, participated in the study.
  • In all subjects, menopausal status will be confirmed by levels of serum follicle stimulating hormone and estradiol in the postmenopausal range.

Inclusion criteria will be:

  • an intact uterus,
  • a washout period of 8 weeks for oral estrogens with or without progestogens, androgens, or selective estrogen receptor modulators (SERMs), four weeks for transdermal or local sex steroids, and 20 weeks for injections of medroxyprogesterone acetate (MPA) containing contraceptives.

Exclusion Criteria:

  • neoplastic, metabolic and infectious diseases,
  • a uterine size greater than that consistent with a 12-week gestation,
  • any abnormality on bimanual pelvic examination,
  • concomitant use of any hormonal drug,
  • body mass index (BMI) > 30 kg/m2,
  • cigarette smoking and an endometrial thickness > 5 mm or the presence of any endometrial abnormalities on transvaginal ultrasound (TV-US).
  • No subjects have present or past history of venous thrombosis, cerebrovascular or cardiovascular disease, and
  • women were excluded if they had any condition that could alter the pharmacokinetics or hypersensitivity to drospirenone/estradiol and tibolone.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384408


Locations
Brazil
Vale Do Sapucai University (Univas)
Pouso Alegre, MG, Brazil, 37550-000
Sponsors and Collaborators
Universidade do Vale do Sapucai
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Investigators
Principal Investigator: Benedito F Reis, Prof Faculdade de Ciências Médicas da Santa Casa de São Paulo

Publications of Results:

Responsible Party: Benedito Fabiano dos Reis, Professor, Universidade do Vale do Sapucai
ClinicalTrials.gov Identifier: NCT02384408     History of Changes
Other Study ID Numbers: 10979112.1.3001.5479
598.391-0 ( Other Identifier: FCMSCSP )
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015

Keywords provided by Benedito Fabiano dos Reis, Universidade do Vale do Sapucai:
menopause
drospirenone
tibolone
Bcl-2
steroid receptors

Additional relevant MeSH terms:
Estrogen Receptor Modulators
Hormones
Tibolone
Drospirenone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Androgen Antagonists
Antihypertensive Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents