Postmenopausal SymptomsEarly Phase 1NCT06369363
Estrogen Deficiency on Cardiovascular Risk
A Early Phase 1 study testing Estradiol in people with Postmenopausal Symptoms and Cardiovascular Diseases, run by Milton S. Hershey Medical Center.
Trial summary
To explore how estrogen deficiency impacts the blood pressure (BP) and sympathetic nerve activity (SNA), and how it impacts the production of the key pro-inflammatory mediators such as Tumor necrosis factor α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6). Read more about this study
- Who is it for?
- Ages 54 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Symptoms, Cardiovascular Diseases
- What is being tested?
- Estradiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Nov 2028
- Phase
- Early Phase 1
- 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 54 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 54-75 years
- Healthy participants who are capable of giving informed consent
- Classified as postmenopausal or stop having period >1year or had a full hysterectomy surgery
- Any race or ethnicity
- Have satisfactory history and physical exam
- Free of acute medical conditions
Who cannot join
- <54 or >75 years
- Medications that could alter cardiovascular, thermoregulatory, or peripheral vascular control (e.g. Angiotensin converting enzyme inhibitors, statins, beta blockers, etc.);
- Self-reported history of long-term menstrual irregularities, vaginal bleeding, or other gynecological conditions that could influence study outcomes
- Use of hormone therapy during 6 months prior to study enrollment
- Allergy to latex
- Current smoker
Show all 15Show fewer
- Have any clinically relevant history or the presence of metabolic (e.g., diabetes), respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, or other disease or diseases that, in the opinion of the research team, exclude the subject from participation.
- Presenting with a resting blood pressure of 150/100 or higher
- Contraindications to a maximal exercise test or an indication for early termination of an exercise test
- Taking any medications that affect vascular control or autonomic function (e.g. beta blockers, ACE inhibitors, calcium channel blockers, etc.)
- Contraindications to estrogen patch: include undiagnosed vaginal bleeding; known, suspected, or history of breast cancer; known or suspected E2-sensitive neoplasm; history of deep venous thrombosis or pulmonary embolism; current or recent arterial thromboembolic disease; liver dysfunction and disease; known or suspected pregnancy.
- Past/current history of venous thromboembolism, hypercoagulation or thrombopenia
- Past/current history of hormone-responsive cancer
- Past/current history of endometrial hyperplasia
- Patient has a recent drug or alcohol abuse history (less than 6 months) or is currently using or abusing excessive alcohol or drugs. Excessive alcohol will be defined as greater than 14 drinks per week.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Estrogen Deficiency on Cardiovascular Risk: Sympathetic Responses and Pro-inflammatory Cytokines
To explore how estrogen deficiency impacts the blood pressure (BP) and sympathetic nerve activity (SNA), and how it impacts the production of the key pro-inflammatory mediators such as Tumor necrosis factor α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6). It is hypothesized that estrogen deficiency increases BP, SNA and the pathway activities of the key pro-inflammatory mediators. Those effects are impacted through the downregulation of the estrogen receptor.
Read the detailed description
In the United States, cardiovascular disease (CVD) is one of the major health concerns and affects approximately 6.5 million people over 40. As the number of elderly women increases, CVD becomes an increasing problem. Estrogen is cardioprotective, and the menopause condition in the aging female population induces the loss of this protective effect. There has been a dilemma for medical treatment in CVD patients with comorbidities including endometriosis or breast cancer history. Overall, these patients lose the cardioprotective effect of estrogen and increase the risk of CVD development. However, there is still little understanding regarding the mechanism for how estrogen suppression in women accelerates CVD development. The proposed studies are, therefore, the essential first step to elucidating how estrogen alters mechanisms underlying CVD and provide the preclinical data to design studies for future alternative intervention strategies for CVD patients undergoing estrogen suppression therapies.
- Conditions
- Postmenopausal Symptoms, Cardiovascular Diseases
- Being tested
- Placebo, Estradiol
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Subjects will be assigned to 1 week of transdermal placebo patch.
EstradiolDrug
Subjects will be assigned to 1 week of transdermal estradiol (0.05 mg/day) patch.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Estradiol | Experimental | Not described Receives: Drug: Estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red blood cell flux
Percentage relative to the maximum flux level
Measured: Recorded continuously for up to 4 hours during the study visit
Mean arterial pressure (mmHg)
Calculated from the systolic and diastolic blood pressure
Measured: Recorded continuously for up to 4 hours during the study visit
baseline plasma TNF-α concentration (pg/ml)
Measured by ELISA kits
Measured: Upon participants' arrival to the first study visit up to 5 minutes
One week post-intervention plasma TNF-α concentration (pg/ml)
Measured by ELISA kits
Measured: Upon participants' arrival to the second study visit (1 week after the first visit)
baseline plasma IL-1β concentration (pg/ml)
Measured by ELISA kits
Measured: Upon participants' arrival to the first study visits up to 5 minutes
One week post-intervention plasma IL-1β concentration (pg/ml)
Measured by ELISA kits
Measured: Upon participants' arrival to the second study visit (1 week after the first visit)
baseline plasma IL-6 concentration (pg/ml)
Measured by ELISA kits
Measured: Upon participants' arrival to the first study visits up to 5 minutes
One week post-intervention plasma IL-6 concentration (pg/ml)
Measured by ELISA kits
Measured: Upon participants' arrival to the second study visit (1 week after the first visit)
Secondary outcomes (2)
baseline plasma estrogen (pg/ml)
Measured by ELISA kits
Measured: Upon participants' arrival to the first study visits up to 5 minutes
One week post-intervention plasma estrogen (pg/ml)
Measured by ELISA kits
Measured: Upon participants' arrival to the second study visit (1 week after the first visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal SymptomsStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Qin, Milton S. Hershey Medical Center
- Investigators
- Lu Qin, PhD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369363
- Sponsor's protocol ID
- STUDY000024245
- Status last verified
- Nov 2025
- First submitted
- 11 Apr 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estrogen Deficiency on Cardiovascular Risk: Sympathetic Responses and Pro-inflammatory Cytokines
- ClinicalTrials.gov ID
- NCT06369363
- Acronym / sponsor ID
- STUDY000024245
- Conditions
- Postmenopausal Symptoms, Cardiovascular Diseases
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 17 Apr 2024 (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.
To explore how estrogen deficiency impacts the blood pressure (BP) and sympathetic nerve activity (SNA), and how it impacts the production of the key pro-inflammatory mediators such as Tumor necrosis factor α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6). It is hypothesized that estrogen deficiency increases BP, SNA and the pathway activities of the key pro-inflammatory mediators. Those effects are impacted through the downregulation of the estrogen receptor.
Detailed description
In the United States, cardiovascular disease (CVD) is one of the major health concerns and affects approximately 6.5 million people over 40. As the number of elderly women increases, CVD becomes an increasing problem. Estrogen is cardioprotective, and the menopause condition in the aging female population induces the loss of this protective effect. There has been a dilemma for medical treatment in CVD patients with comorbidities including endometriosis or breast cancer history. Overall, these patients lose the cardioprotective effect of estrogen and increase the risk of CVD development. However, there is still little understanding regarding the mechanism for how estrogen suppression in women accelerates CVD development. The proposed studies are, therefore, the essential first step to elucidating how estrogen alters mechanisms underlying CVD and provide the preclinical data to design studies for future alternative intervention strategies for CVD patients undergoing estrogen suppression therapies.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Estradiol | Experimental | Drug: Estradiol |
Who may qualify
- Ages
- 54 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 54-75 years
- Healthy participants who are capable of giving informed consent
- Classified as postmenopausal or stop having period >1year or had a full hysterectomy surgery
- Any race or ethnicity
- Have satisfactory history and physical exam
Key exclusion criteria (15 listed)
- <54 or >75 years
- Medications that could alter cardiovascular, thermoregulatory, or peripheral vascular control (e.g. Angiotensin converting enzyme inhibitors, statins, beta blockers, etc.);
- Self-reported history of long-term menstrual irregularities, vaginal bleeding, or other gynecological conditions that could influence study outcomes
- Use of hormone therapy during 6 months prior to study enrollment
- Allergy to latex
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 |
|---|---|---|
| PlaceboSubjects will be assigned to 1 week of transdermal placebo patch. | Drug | Placebo |
| EstradiolSubjects will be assigned to 1 week of transdermal estradiol (0.05 mg/day) patch. | Drug | Estradiol |
Primary outcome
Red blood cell flux
Time frame: Recorded continuously for up to 4 hours during the study visit
Percentage relative to the maximum flux level
Mean arterial pressure (mmHg)
Time frame: Recorded continuously for up to 4 hours during the study visit
Calculated from the systolic and diastolic blood pressure
baseline plasma TNF-α concentration (pg/ml)
Time frame: Upon participants' arrival to the first study visit up to 5 minutes
Measured by ELISA kits
One week post-intervention plasma TNF-α concentration (pg/ml)
Time frame: Upon participants' arrival to the second study visit (1 week after the first visit)
Measured by ELISA kits
baseline plasma IL-1β concentration (pg/ml)
Time frame: Upon participants' arrival to the first study visits up to 5 minutes
Measured by ELISA kits
One week post-intervention plasma IL-1β concentration (pg/ml)
Time frame: Upon participants' arrival to the second study visit (1 week after the first visit)
Measured by ELISA kits
baseline plasma IL-6 concentration (pg/ml)
Time frame: Upon participants' arrival to the first study visits up to 5 minutes
Measured by ELISA kits
One week post-intervention plasma IL-6 concentration (pg/ml)
Time frame: Upon participants' arrival to the second study visit (1 week after the first visit)
Measured by ELISA kits
2 secondary outcomes
baseline plasma estrogen (pg/ml)
Time frame: Upon participants' arrival to the first study visits up to 5 minutes
One week post-intervention plasma estrogen (pg/ml)
Time frame: Upon participants' arrival to the second study visit (1 week after the first visit)
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 17 Nov 2025.
Related trials for Postmenopausal Symptoms
Active, not recruitingPhase 1/2
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
Vasomotor Symptoms Associated With Menopause, Healthy Volunteers
Recruiting
The Impact of Overnight Active Temperature Regulation on the Gut Microbiome, Inflammation, and Circadian Rhythm.
Poor Sleep Quality, Gut Microbiome
RecruitingPhase 2
A Clinical Trial Comparing the Efficacy and Safety of Different Doses of BL0175 Injection in Treating Postmenopausal Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced or Metastatic Breast Cancer
Breast Cancer (Locally Advanced or Metastatic)
RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
Recruiting
Exploration of the Effect of a Wheat Polar Lipid Complex on Vaginal Dryness in Healthy Postmenopausal Women
Vaginal Dryness, Menopause Symptoms
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.
Lu Qin, PhD principal investigator
Penn State College of Medicine
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Estradiol in people with Postmenopausal Symptoms and Cardiovascular Diseases, run by Milton S. Hershey Medical Center.
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 6 inclusion and 15 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: opening soon, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Contact Lu Qin, PhD (4026096068, lqin@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Red blood cell flux (time frame: Recorded continuously for up to 4 hours during the study visit). The study lists 8 primary outcomes in all. 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 17 Nov 2025.