MenopausePhase 2ARESINCT07754630
Analysis of the Hormonal Implant and Transdermal Estradiol Gel in Climacteric Women
A Phase 2 study testing implantable estradiol, OESTROGEL - transdermal gel and PENTRAVAN - transdermal gel in people with Menopause and Hypoestrogenism, run by Nutrindo Ideais Research Center at 1 site in Brazil.
Trial summary
An open-label, prospective clinical study will be conducted to monitor serum concentration and pharmacokinetic profiles following the subcutaneous implantation of six silicone hormone implants (delivering a total dose of 300 mg of estradiol) versus the use of transdermal estradiol gel (at a daily dose of 3.0 mg). Read more about this study
- Who is it for?
- Ages 41 to 59 years, women only
- Conditions the study is for
- Menopause, Hypoestrogenism, Hormonal Therapy
- What is being tested?
- implantable estradiol, OESTROGEL - transdermal gel and PENTRAVAN - transdermal gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Feb 2025to 1 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 41 to 59 years with climacteric symptoms, weighing 50 to 90 kg, with a BMI of 18.5 to 34.9 kg/m². Hysterectomy (with or without oophorectomy). Hypoestrogenism defined by a total serum estradiol concentration ≤ 50 pg/mL and a serum FSH concentration ≥ 25 mIU/mL. Absence of signs, symptoms, or clinical findings suggestive of breast cancer, as evidenced by a mammography report (for women > 40 years of age) dated within the last 12 months showing BI-RADS 1 or BI-RADS 2 classification. Agreement not to use other hormones (estrogens, androgens, and/or progestogens) or contraceptives in any pharmaceutical form during the study.
Who cannot join
- Contraindications to the use of menopausal hormone therapy: vaginal bleeding of unknown cause; personal history of hormone-dependent neoplasia, including breast cancer or breast cancer precursor lesions; liver disease; porphyria; personal history of coronary artery disease, cerebrovascular disease, or venous thromboembolism; systemic lupus erythematosus with high thromboembolic risk; and meningioma. Comorbidities associated with increased cardiovascular risk: smoking, uncontrolled diabetes, dyslipidemia, and uncontrolled hypertension. Severe chronic disorders, including metastatic malignancies, end-stage renal disease (with or without dialysis), clinically unstable heart disease, or any other disorder that, in the investigator's opinion, excludes the participant from the study. Immunocompromise or suspected/confirmed diagnosis of immunodeficiency based on history and/or physical or laboratory examination. Active liver disease or dysfunction. Benign or malignant liver tumors. Clinical diagnosis of polycystic ovary syndrome. Use of other hormones (estrogens, androgens, and/or progestogens) in any pharmaceutical form within the last month. Use of contraceptives. Current use of medications that alter cytochrome P450 activity and estrogen metabolism. Current use of tamoxifen, aromatase inhibitors, or GnRH agonists/antagonists for cancer or any other condition. Current use of phytoestrogens. Participation in another clinical study within 30 days prior to the start of study treatment. Patients who do not complete all study stages, who do not adhere to the intervention, or who experience an intercurrent event that interferes with the study outcome.
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Trial locations and contacts
1 site in 1 country.
Brazil1 site
Nutrindo Ideais Research Center
Rio de Janeiro, Rio de Janeiro, 22421000
About this study
Official title: Comparison Between the Silastic Hormonal Implant and Transdermal Estradiol Gel in Climacteric Women: a Randomized Controlled Clinical Trial
An open-label, prospective clinical study will be conducted to monitor serum concentration and pharmacokinetic profiles following the subcutaneous implantation of six silicone hormone implants (delivering a total dose of 300 mg of estradiol) versus the use of transdermal estradiol gel (at a daily dose of 3.0 mg). Assessment of total serum estradiol concentration and determination of pharmacokinetic parameters will be performed in eligible participants before and after hormone implant insertion and transdermal estradiol gel use, at various sampling time points (within the first 24 hours, weekly during the first month, and monthly up to 6 full months). Additionally, the concentrations of other hormones influenced by estradiol activity (total testosterone, estrone, FSH, LH, SHBG, and prolactin) will be determined. Medical consultations for clinical assessment and participant follow-up will be conducted at baseline and at 1, 3, and 6 months. The primary outcome assessment will be performed 6 months after the crossover between hormone implant insertion and transdermal estradiol gel use.
- Conditions
- Menopause, Hypoestrogenism, Hormonal Therapy
- Being tested
- implantable estradiol, OESTROGEL - transdermal gel, PENTRAVAN - transdermal gel
- Keywords
- Menopause; Hypoestrogenism; Climacteric; Subdermal implant; Estradiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implantable estradiolDrug
The assessment will include medical history, a physical examination, routine screening laboratory tests, a mammogram, and, when necessary, a transvaginal ultrasound. Each subject's body weight, height, and blood pressure will be recorded by an investigator. Subsequently, each of the 50 women will receive six (6) estradiol implants, each with a dose of 50 mg, totaling 300 mg (Elmeco, Salvador, Brazil). Each implant (40 mm in diameter) will be inserted subcutaneously into the buttock under local anesthesia. Following insertion, the patient will remain under observation at the clinic for the collection of multiple blood samples; these will be taken prior to the insertion of the Silastic implants and at 2, 4, 6, 8, 10, and 12 hours post-insertion.
Patients will be instructed regarding their follow-up visits, which are scheduled for 24 hours, 7 days, 14 days, 21 days, 28 days, 56 days, 84 days, 112 days, 140 days, and 168 days.
OESTROGEL - transdermal gelDrug
Medical consultations for clinical assessment will be conducted, involving the completion of a questionnaire on menopausal symptoms and participant follow-up at baseline (t0) and at 1, 3, and 6 months. The Menopause Rating Scale (MRS) (Heinemann et al., 2004) will be used for the questionnaire. During all follow-up visits, volunteers will undergo a physical examination, including a breast exam; measurements of blood pressure, weight, body mass index (BMI), and hip and waist circumferences; and bioimpedance analysis.
PENTRAVAN - transdermal gelDrug
Medical consultations for clinical assessment will be conducted, involving the completion of a questionnaire on menopausal symptoms and participant follow-up at baseline (t0) and at 1, 3, and 6 months. The Menopause Rating Scale (MRS) (Heinemann et al., 2004) will be used for the questionnaire. During all follow-up visits, volunteers will undergo a physical examination, including a breast exam; measurements of blood pressure, weight, body mass index (BMI), and hip and waist circumferences; and bioimpedance analysis.
| Study group | Role | What they receive |
|---|---|---|
| IMPLANT | Experimental | For the 50 patients, the placement and removal of the gluteal implants will be performed by a single physician from the clinic to ensure study standardization. All patients will receive post-implant instructions, including keeping the dressing in place for 5 days. After this period, the dressing should be removed, and the patient may bathe normally, lathering and rinsing the area and drying it carefully afterward. Following the bath, 70% alcohol should be applied and allowed to air dry. Participants must refrain from physical activity for 3 days after implant placement. Participants will be instructed to apply an ice pack for 15 minutes in the hours following the procedure and to continue this measure over the subsequent days if local swelling occurs. The initial assessment will include medical history, a physical examination, routine screening laboratory tests, mammography, and, when necessary, transvaginal ultrasound. Receives: Drug: implantable estradiol |
| PENTRAVAN | Active comparator | The 25 volunteers in the group will follow the same protocol, except for the use of the 3.0 mg PENTRAVAN compounded estradiol gel, which must be applied daily in the morning to clean skin on the arm or leg after bathing; the gel must not be mixed with other creams or similar products. Receives: Drug: PENTRAVAN - transdermal gel |
| OESTROGEL | Active comparator | The 25 volunteers in the group will follow the same protocol, except for the use of the 3.0 mg OESTROGEL estradiol gel, which must be applied daily in the morning to clean skin on the arm or leg after bathing; the gel must not be mixed with other creams or similar products. Receives: Drug: OESTROGEL - transdermal gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
hormonal implant and PENTRAVAN transdermal gel pharmacokinetics
Assessment of total serum estradiol concentration (silastic implant versus transdermal gel). Multiple blood samples will be collected at 0, 2, 4, 6, 8, 10, 12, and 24 hours; and at 7, 14, 21, 28, 56, 84, 112, 140, and 168 days, and will be analyzed using liquid chromatography (LC-MS/MS).
Measured: From enrollment to the end of treatment at 168 days
Secondary outcomes (1)
menopausal symptoms
Assessment of menopausal symptoms and participant follow-up at baseline (T0), and after 1, 3, and 6 months. The Menopause Rating Scale (MRS) questionnaire will be used.
Measured: From enrollment to the end of treatment at 168 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start25 Feb 2025
- Primary completion1 May 2026
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Instrument The study will be prospective with cross-sectional analyses involving a sample of volunteers randomized into two groups. Group 1 (G1) will consist of 25 patients who, at baseline (t0), undergo an in-person medical consultation for clinical assessment and laboratory sample collection. Subsequently, a Silastic implant-a minimally invasive procedure-will be inserted under local anesthesia into the patient's right or left gluteal region. Medical consultations for clinical assessment, including the completion of a menopause symptom questionnaire and participant follow-up, will be conducted at baseline (t0) and at 1, 3, and 6 months. The Menopause Rating Scale (MRS) (Heinemann et al., 2004) will be used as the questionnaire. During all follow-up visits, volunteers will undergo a physical examination, including breast examination, measurement of blood pressure, weight, body mass index (BMI), hip and waist circumferences, and bioimpedance analysis.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutrindo Ideais Research Center
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Guilherme Renke, Principal investigator, Department of Endocrinology and Nutrition - Nutrindo Ideais Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754630
- Sponsor's protocol ID
- 86424525.3.0000.5257
- Acronym
- ARESI
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The ethics committee that approved this study does not permit sharing of IPD.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Silastic Hormonal Implant and Transdermal Estradiol Gel in Climacteric Women: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07754630
- Acronym / sponsor ID
- ARESI / 86424525.3.0000.5257
- Conditions
- Menopause, Hypoestrogenism, Hormonal Therapy
- Keywords
- Menopause; Hypoestrogenism; Climacteric; Subdermal implant; Estradiol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nutrindo Ideais Research CenterResearch network
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, prospective clinical study will be conducted to monitor serum concentration and pharmacokinetic profiles following the subcutaneous implantation of six silicone hormone implants (delivering a total dose of 300 mg of estradiol) versus the use of transdermal estradiol gel (at a daily dose of 3.0 mg). Assessment of total serum estradiol concentration and determination of pharmacokinetic parameters will be performed in eligible participants before and after hormone implant insertion and transdermal estradiol gel use, at various sampling time points (within the first 24 hours, weekly during the first month, and monthly up to 6 full months). Additionally, the concentrations of other hormones influenced by estradiol activity (total testosterone, estrone, FSH, LH, SHBG, and prolactin) will be determined. Medical consultations for clinical assessment and participant follow-up will be conducted at baseline and at 1, 3, and 6 months. The primary outcome assessment will be performed 6 months after the crossover between hormone implant insertion and transdermal estradiol gel use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Instrument The study will be prospective with cross-sectional analyses involving a sample of volunteers randomized into two groups. Group 1 (G1) will consist of 25 patients who, at baseline (t0), undergo an in-person medical consultation for clinical assessment and laboratory sample collection. Subsequently, a Silastic implant-a minimally invasive procedure-will be inserted under local anesthesia into the patient's right or left gluteal region. Medical consultations for clinical assessment, including the completion of a menopause symptom questionnaire and participant follow-up, will be conducted at baseline (t0) and at 1, 3, and 6 months. The Menopause Rating Scale (MRS) (Heinemann et al., 2004) will be used as the questionnaire. During all follow-up visits, volunteers will undergo a physical examination, including breast examination, measurement of blood pressure, weight, body mass index (BMI), hip and waist circumferences, and bioimpedance analysis.
| Arm | Type | Receives |
|---|---|---|
| IMPLANT | Experimental | Drug: implantable estradiolFor the 50 patients, the placement and removal of the gluteal implants will be performed by a single physician from the clinic to ensure study standardization. All patients will receive post-implant instructions, including keeping the dressing in place for 5 days. After this period, the dressing should be removed, and the patient may bathe normally, lathering and rinsing the area and drying it carefully afterward. Following the bath, 70% alcohol should be applied and allowed to air dry. Participants must refrain from physical activity for 3 days after implant placement. Participants will be instructed to apply an ice pack for 15 minutes in the hours following the procedure and to continue this measure over the subsequent days if local swelling occurs. The initial assessment will include medical history, a physical examination, routine screening laboratory tests, mammography, and, when necessary, transvaginal ultrasound. |
| PENTRAVAN | Active comparator | Drug: PENTRAVAN - transdermal gelThe 25 volunteers in the group will follow the same protocol, except for the use of the 3.0 mg PENTRAVAN compounded estradiol gel, which must be applied daily in the morning to clean skin on the arm or leg after bathing; the gel must not be mixed with other creams or similar products. |
| OESTROGEL | Active comparator | Drug: OESTROGEL - transdermal gelThe 25 volunteers in the group will follow the same protocol, except for the use of the 3.0 mg OESTROGEL estradiol gel, which must be applied daily in the morning to clean skin on the arm or leg after bathing; the gel must not be mixed with other creams or similar products. |
Who may qualify
- Ages
- 41 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women aged 41 to 59 years with climacteric symptoms, weighing 50 to 90 kg, with a BMI of 18.5 to 34.9 kg/m². Hysterectomy (with or without oophorectomy). Hypoestrogenism defined by a total serum estradiol concentration ≤ 50 pg/mL and a serum FSH concentration ≥ 25 mIU/mL. Absence of signs, symptoms, or clinical findings suggestive of breast cancer, as evidenced by a mammography report (for women > 40 years of age) dated within the last 12 months showing BI-RADS 1 or BI-RADS 2 classification. Agreement not to use other hormones (estrogens, androgens, and/or progestogens) or contraceptives in any pharmaceutical form during the study.
Key exclusion criteria (2 listed)
- Contraindications to the use of menopausal hormone therapy: vaginal bleeding of unknown cause; personal history of hormone-dependent neoplasia, including breast cancer or breast cancer precursor lesions; liver disease; porphyria; personal history of coronary artery disease, cerebrovascular disease, or venous thromboembolism; systemic lupus erythematosus with high thromboembolic risk; and meningioma. Comorbidities associated with increased cardiovascular risk: smoking, uncontrolled diabetes, dyslipidemia, and uncontrolled hypertension. Severe chronic disorders, including metastatic malignancies, end-stage renal disease (with or without dialysis), clinically unstable heart disease, or any other disorder that, in the investigator's opinion, excludes the participant from the study. Immunocompromise or suspected/confirmed diagnosis of immunodeficiency based on history and/or physical or laboratory examination. Active liver disease or dysfunction. Benign or malignant liver tumors. Clinical diagnosis of polycystic ovary syndrome. Use of other hormones (estrogens, androgens, and/or progestogens) in any pharmaceutical form within the last month. Use of contraceptives. Current use of medications that alter cytochrome P450 activity and estrogen metabolism. Current use of tamoxifen, aromatase inhibitors, or GnRH agonists/antagonists for cancer or any other condition. Current use of phytoestrogens. Participation in another clinical study within 30 days prior to the start of study treatment. Patients who do not complete all study stages, who do not adhere to the intervention, or who experience an intercurrent event that interferes with the study outcome.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implantable estradiolThe assessment will include medical history, a physical examination, routine screening laboratory tests, a mammogram, and, when necessary, a transvaginal ultrasound. Each subject's body weight, height, and blood pressure will be recorded by an investigator. Subsequently, each of the 50 women will receive six (6) estradiol implants, each with a dose of 50 mg, totaling 300 mg (Elmeco, Salvador, Brazil). Each implant (40 mm in diameter) will be inserted subcutaneously into the buttock under local anesthesia. Following insertion, the patient will remain under observation at the clinic for the collection of multiple blood samples; these will be taken prior to the insertion of the Silastic implants and at 2, 4, 6, 8, 10, and 12 hours post-insertion. Patients will be instructed regarding their follow-up visits, which are scheduled for 24 hours, 7 days, 14 days, 21 days, 28 days, 56 days, 84 days, 112 days, 140 days, and 168 days. | Drug | IMPLANT |
| OESTROGEL - transdermal gelMedical consultations for clinical assessment will be conducted, involving the completion of a questionnaire on menopausal symptoms and participant follow-up at baseline (t0) and at 1, 3, and 6 months. The Menopause Rating Scale (MRS) (Heinemann et al., 2004) will be used for the questionnaire. During all follow-up visits, volunteers will undergo a physical examination, including a breast exam; measurements of blood pressure, weight, body mass index (BMI), and hip and waist circumferences; and bioimpedance analysis. | Drug | OESTROGEL |
| PENTRAVAN - transdermal gelMedical consultations for clinical assessment will be conducted, involving the completion of a questionnaire on menopausal symptoms and participant follow-up at baseline (t0) and at 1, 3, and 6 months. The Menopause Rating Scale (MRS) (Heinemann et al., 2004) will be used for the questionnaire. During all follow-up visits, volunteers will undergo a physical examination, including a breast exam; measurements of blood pressure, weight, body mass index (BMI), and hip and waist circumferences; and bioimpedance analysis. | Drug | PENTRAVAN |
Primary outcome
hormonal implant and PENTRAVAN transdermal gel pharmacokinetics
Time frame: From enrollment to the end of treatment at 168 days
Assessment of total serum estradiol concentration (silastic implant versus transdermal gel). Multiple blood samples will be collected at 0, 2, 4, 6, 8, 10, 12, and 24 hours; and at 7, 14, 21, 28, 56, 84, 112, 140, and 168 days, and will be analyzed using liquid chromatography (LC-MS/MS).
1 secondary outcome
menopausal symptoms
Time frame: From enrollment to the end of treatment at 168 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No. The ethics committee that approved this study does not permit sharing of IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guilherme Renke principal investigator
Department of Endocrinology and Nutrition - Nutrindo Ideais Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing implantable estradiol, OESTROGEL - transdermal gel and PENTRAVAN - transdermal gel in people with Menopause and Hypoestrogenism, run by Nutrindo Ideais Research Center at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hormonal implant and PENTRAVAN transdermal gel pharmacokinetics (time frame: From enrollment to the end of treatment at 168 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.