Actively Recruiting

Phase 3
Age: 18Years - 60Years
FEMALE
ID06343870

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

Led by University of Sao Paulo General Hospital · Updated on 2025-12-29

140

Participants Needed

1

Research Sites

36 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying menopausal women with estrogen and androgen deficiencies, including those with natural menopause, premature ovarian failure, or surgical menopause due to cervical cancer. The study evaluates the use of subdermal bioabsorbable implants of estradiol and testosterone to address menopausal and sexual symptoms. It is a phase 3 clinical trial assessing pharmacokinetic, biochemical, metabolic, thromboembolic, and hormonal effects, along with quality of life and sexual function changes. The trial involves 140 women divided into three groups: postmenopausal women with symptoms, women under 40 with premature ovarian failure, and women with surgical menopause after hysterectomy for cervical cancer. Participants receive either a testosterone bioabsorbable implant (100 mg) or a placebo pellet made of cholesterol. The study lasts six months, with follow-up visits at 1, 3, and 6 months post-implantation. Blood samples are collected at multiple time points to measure hormone levels and related biochemical markers. Participants will undergo questionnaires assessing quality of life, menopausal symptoms, and sexual function, along with general physical and gynecological exams and imaging tests. Hormonal, clinical, biochemical, and therapeutic parameters are evaluated at baseline, 3 months, and 6 months. Safety and treatment effects are analyzed statistically. The study focuses on measuring hormonal, metabolic, thromboembolic, and clinical impacts on climacteric symptoms over six months.

CONDITIONS

Brief Title

Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)

Who Can Participate

Age: 18Years - 60Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Menopause time of 2 to 6 years
  • Body Mass Index between 25 and 30 kg/m2
  • Women who had hysterectomy and ovariectomy due to cervical cancer
  • Women under 40 years old with premature ovarian failure
  • Active sex life
  • No severe depression or anxiety confirmed by Beck questionnaires
Not Eligible

You will not qualify if you...

  • Disabling illnesses
  • Use of medications that inhibit sexual desire
  • Inability to answer questionnaires
  • Severe hypertension with blood pressure > 160 x 90 mmHg in two measurements
  • Clinical or subclinical thyroid dysfunction with TSH > 4 mIU/L
  • Dyslipidemia with fasting triglycerides > 400 mg/dL
  • Presence of occult blood in feces
  • Hyperprolactinemia > 29 ng/mL
  • Fasting blood glucose > 100 mg/dL
  • Presence of osteopenia or osteoporosis
  • BIRADS classification ≥ 3 on mammography
  • Endometrial echo > 4 mm on transvaginal ultrasound
  • Changes in oncotic colpocytology
  • Moderate to severe anxiety or depression diagnosed by psychological screening

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants receive a subdermal implant of either a testosterone pellet or a placebo pellet and are monitored for hormonal, metabolic, thromboembolic, and clinical effects on menopausal symptoms.

Inclusion visit and visits at 1, 3, and 6 months after implant insertion

Trial Site Locations

Total: 1 location

1

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil, 05401-000

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Research Team

A

André Malavasi, PhD

E

Edmund Baracat, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Sustained-release estradiol implants and a levonorgestrel-releasing intrauterine device in hormone replacement therapy.

S P Suhonen, H O Allonen, P Lähteenmäki

https://pubmed.ncbi.nlm.nih.gov/7856686