Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME) (ESTIME)

March 26, 2024 updated by: Edmund Baracat, University of Sao Paulo General Hospital

Pharmacokinetic, Clinical, Hormonal and Therapeutic Effects of the Use of Estradiol and Testosterone Hormonal Subdermal Implants in Women With Natural Menopause, Premature Ovarian Failure or Surgical Menopause Due to Cervical Cancer.

Estrogen and androgen deficiencies negatively impact the quality of life of women at different stages of life, especially after menopause. New modalities and new therapeutic alternatives have been researched. Parenteral administration of estradiol and testosterone could be effective to treat symptoms secondary to estrogen and androgen deficiencies and minimize these adverse events. This study evaluates the efficiency of subdermal implant-bioabsorbable use in women with menopausal symptoms associated with secondary estrogen and androgen deficiencies in women with natural menopause, premature ovarian failure or surgical menopause due to cervical cancer. Pharmacokinetic, biochemical, metabolic, thromboembolic and hormonal data will be evaluated, as well as the effects on quality of life, menopausal symptoms and sexual function after treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The clinical study will be carried out on 140 women, who will be divided into three groups: (1) postmenopausal women with menopausal and sexual symptoms (n=60); (2) women with premature ovarian failure (n=40); (3) women with cervical cancer undergoing abdominal hysterectomy with bilateral adnexectomy, with menopausal and sexual symptoms (n=40).

All participants will answer questionnaires to assess quality of life, menopausal symptoms and sexual function. All participants will undergo general physical and gynecological examinations, as well as hormonal, biochemical, thromboembolic and imaging tests.

The study will last six months. The included participants will undergo the following visits: inclusion (post-selection) and 1, 3 and 6 months after implant insertion. For the pharmacokinetic study, blood samples will be collected at the following periods: inclusion (before implant placement) and after 1h, 2h, 3h, 6h and 12h; one week, two weeks and one month after placement, and then monthly until six months after implant insertion, to evaluate serum levels of Luteinizing hormone, Follicle stimulating hormone, estradiol, estrone, total testosterone and sex hormone-binding globulin.

Clinical, biochemical, hormonal and therapeutic parameters will be evaluated before placement (inclusion) and after 3 and 6 months. The Mann Whitney test will be applied to evaluate differences between measurements and the chi-square test will be applied to analyze the proportions of improvement between groups before and after treatment.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • menopause time of 2 to 6 years;
  • Body Mass Index between 25 and 30 kg/m2;
  • women hysterectomized and ovariectomized due to cervical cancer;
  • women with premature ovarian failure and under 40 years of age;
  • active sex life;
  • absence of severe depression and anxiety, confirmed by evaluation using the Beck (specific for depression) and Beck (specific for anxiety) questionnaires.

Exclusion Criteria:

  • disabling illnesses;
  • use of medications that inhibit sexual desire;
  • inability to answer the questionnaires;

  • altered routine exams and comorbidities:

    • Severe hypertension with Blood Pressure measurement > 160 x 90 mmHg in two measurements
    • clinical or subclinical thyroid dysfunction with Thyroid-stimulating hormone > 4 mIU/L
    • dyslipidemia - fasting triglyceride level > 400 mg/dL
    • presence of occult blood in feces
    • hyperprolactinemia (>29ng/mL)
    • fasting blood glucose > 100 mg/dL
    • presence of osteopenia or osteoporosis
    • BIRADS classification greater than or equal to 3 on mammography
    • presence of endometrial echo > 4mm on transvaginal ultrasound
    • presence of changes in oncotic colpocytology
  • diagnosis after psychological screening of moderate to severe anxiety/depression.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Testosterone
Subdermal implant-bioabsorbable testosterone pellet (100 mg of testosterone)
Drug: testosterone pellet (100 mg)
Intervention arm: Subdermal implant-bioabsorbable testosterone pellet (100 mg of testosterone)
Other Names:
  • testosterone subdermal implant
Placebo Comparator: Placebo
Subdermal implant-bioabsorbable placebo pellet (cholesterol)
Drug: Placebo
Pellet of cholesterol (placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate hormonal, metabolic thromboembolic and clinical effects on climacteric symptoms
Time Frame: 6 months
evaluate concentration in serum of luteinizing hormone, follicle stimulating hormone, estradiol, estrone, total testosterone and sex hormone-binding globulin.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate response in quality of life and sexual function
Time Frame: 6 months
Evaluate response on vulvovaginal atrophy and genitourinary syndrome of menopause, hormonal and metabolic effects on climacteric symptoms, using the Kupperman Menopausal Index; response in quality of life and sexual function; hormonal and metabolic effects;
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Edmund Baracat, PhD, Instituto do Coracao

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 31, 2024

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

March 26, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESTIME

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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