Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME)

NCT06343870 | Recruiting Phase 3 DMC

• 1 other identifier: ESTIME
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Testosterone Deficiency; Estrogen Deficiency; Menopause

Keywords

menopause; estrogen; testosterone

Outcome Measures

Primary Outcomes (1)

• Evaluate hormonal, metabolic thromboembolic and clinical effects on climacteric symptoms

  evaluate concentration in serum of luteinizing hormone, follicle stimulating hormone, estradiol, estrone, total testosterone and sex hormone-binding globulin.

  6 months

Secondary Outcomes (1)

• Evaluate response in quality of life and sexual function

  6 months

Study Arms (2)

Testosterone

ACTIVE COMPARATOR

Subdermal implant-bioabsorbable testosterone pellet (100 mg of testosterone)

Drug: testosterone pellet (100 mg)

Placebo

PLACEBO COMPARATOR

Subdermal implant-bioabsorbable placebo pellet (cholesterol)

Drug: Placebo

Interventions

testosterone pellet (100 mg) DRUG

Intervention arm: Subdermal implant-bioabsorbable testosterone pellet (100 mg of testosterone)

Also known as: testosterone subdermal implant

Testosterone

Placebo DRUG

Pellet of cholesterol (placebo)

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, São Paulo, 05401-000, Brazil

RECRUITING

Related Publications (7)

• 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 BACKGROUND

• Nelson HD. Menopause. Lancet. 2008 Mar 1;371(9614):760-70. doi: 10.1016/S0140-6736(08)60346-3.

  PMID: 18313505 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• Edmund Baracat, PhD

  Instituto do Coracao

  PRINCIPAL INVESTIGATOR

Central Study Contacts

André Malavasi, PhD

CONTACT

55 11 981348231; drandreluiz@usp.br

Edmund Baracat, PhD

CONTACT

55 11 98149-6253

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 3, 2024
• Study Start: December 18, 2025
• Primary Completion (Estimated): August 18, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)