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Recruiting NCT06343870

Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)

Phase III Interventional Menopause Testosterone Deficiency Estrogen Deficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: testosterone pellet (100 mg), Placebo.
Who it may be relevant to
Registry conditions: Menopause, Testosterone Deficiency, Estrogen Deficiency. Basic parameters: 18 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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.

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.

Interventions

  • Drug testosterone pellet (100 mg)
    Intervention arm: Subdermal implant-bioabsorbable testosterone pellet (100 mg of testosterone)
  • Drug Placebo
    Pellet of cholesterol (placebo)

Primary outcome measures

  • Evaluate hormonal, metabolic thromboembolic and clinical effects on climacteric symptoms [Time frame: 6 months]
Secondary outcome measures (1)
  • Evaluate response in quality of life and sexual function [Time frame: 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo — São Paulo

Publications

  • Lev-Sagie A. Vulvar and Vaginal Atrophy: Physiology, Clinical Presentation, and Treatment Considerations. Clin Obstet Gynecol. 2015 Sep;58(3):476-91. doi: 10.1097/GRF.0000000000000126. PMID 26125962
  • Nelson HD. Menopause. Lancet. 2008 Mar 1;371(9614):760-70. doi: 10.1016/S0140-6736(08)60346-3. PMID 18313505
  • Calleja-Agius J, Brincat MP. The urogenital system and the menopause. Climacteric. 2015;18 Suppl 1:18-22. doi: 10.3109/13697137.2015.1078206. PMID 26366796
  • The NAMS 2020 GSM Position Statement Editorial Panel. The 2020 genitourinary syndrome of menopause position statement of The North American Menopause Society. Menopause. 2020 Sep;27(9):976-992. doi: 10.1097/GME.0000000000001609. PMID 32852449
  • Suhonen SP, Allonen HO, Lahteenmaki P. Sustained-release estradiol implants and a levonorgestrel-releasing intrauterine device in hormone replacement therapy. Am J Obstet Gynecol. 1995 Feb;172(2 Pt 1):562-7. doi: 10.1016/0002-9378(95)90573-1. PMID 7856686
  • Kingsberg S, Althof SE. Evaluation and treatment of female sexual disorders. Int Urogynecol J Pelvic Floor Dysfunct. 2009 May;20 Suppl 1:S33-43. doi: 10.1007/s00192-009-0833-x. PMID 19440781
  • Brincat M, Magos A, Studd JW, Cardozo LD, O'Dowd T, Wardle PJ, Cooper D. Subcutaneous hormone implants for the control of climacteric symptoms. A prospective study. Lancet. 1984 Jan 7;1(8367):16-8. doi: 10.1016/s0140-6736(84)90183-1. PMID 6140343

Identifiers

NCT: NCT06343870 · ESTIME

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗