Hot FlashesPhase 2R01NCT02907983
Stellate Ganglion Blockade in Post-Menopausal Women
A Phase 2 study testing Stellate Ganglion Block Injection with Bupivicaine and Saline injection in people with Hot Flashes and Hot Flushes, run by Northwestern University at 2 sites in United States.
Trial summary
Hot flashes and night sweats (vasomotor symptoms, VMS) affect 80% of women during the menopausal transition (MT). VMS are associated with decreased quality of life, increased depressive and anxiety symptoms, memory complaints, sleep disturbance, and reduced work productivity. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flashes, Hot Flushes, Vasomotor Symptoms
- What is being tested?
- Stellate Ganglion Block Injection with Bupivicaine and Saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jul 2018to 24 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- post-menopausal woman defined according to the following criteria: 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels ≥ 40 IU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy
- aged 40 to 70 years
- 50 or more reported moderate-to-severe hot flashes per week
- a minimum of two weeks of VMS diary recording prior to SGB
- post-menopausal women whose vasomotor symptoms are refractory to approved oral treatments (i.e., hormone therapy or paroxetine) or for whom hormone therapy is contraindicated or for women who refuse any oral therapy
- willingness to undergo fluoroscopy-guided SGB or sham treatment.
- safety labs within 30 days of SGB intervention
Who cannot join
- conditions that preclude SGB or sham intervention (e.g., anatomic abnormalities of the anterior neck or cervical spine ; goiter, cardiac/pulmonary compromise; contralateral (left-sided) phrenic nerve paralysis or diaphragmatic paresis; history of seizure, coma, or stroke; history of neurologic deficit to the brachial plexus or an abnormal brachial plexus neurologic exam; history of Zenker's diverticulum; acute illness/infection; coagulopathy or bleeding abnormalities; INR >1.3; hemoglobin<9.0, platelets <100,000, BUN ≥ 30mg/dl; creatinine ≥ 2 mg/ml; ALT (SGPT), AST (SGOT), Alk Phos ≥ three times the upper limit of normal; serum potassium (K+) ≤ 3.5 or ≥ 5.0 mEq/L allergic reactions or contraindications to a local anesthetic or contrast dye, systolic blood pressure (SBP) >140 mm Hg or diastolic blood pressure (DBP) >90 mm Hg, pregnancy
- If LMP is between 6 to 12 months, FSH < 40
- use of treatments less than the washout period and throughout study participation that can affect VMS frequency or severity, including oral (2 months) or transdermal hormone therapy(1 month), botanicals (e.g., soy, red clover, black cohosh, etc.)(1 month), oral contraceptives(2 months), serotonin selective reuptake inhibitors (SSRI) (2 weeks), serotonin norepinephrine reuptake inhibitors (SNRI),( 2 weeks) gabapentin, pregabalin, clonidine, selective estrogen receptor modulators, aromatase inhibitors, tissue selective estrogen complexes;(2months)
- use of aspirin and non-steroidal anti-inflammatory medications for 3 days prior to the SGB procedure; all other anti-platelet or anticoagulation medications will be discontinued with the permission of the participant's prescribing physician
- for cognition testing: conditions or disorders that can affect performance on cognitive tests (e.g., dementia/mild cognitive impairment, Mini-Mental State Exam (MMSE) less than or equal to 27) at baseline; stroke; traumatic brain injury; alcohol/substance use; inability to write, speak, or read in English, English as a second language, participation in other studies involving tests of cognitive abilities,
- conditions that can affect depressive symptoms (e.g., current diagnosis of major depression, bipolar disorder, or other Axis I Psychiatric disorder); Personal Health Questionnaire Depression Scale (PHQ-8)> 15
- Exclusion criteria for neuroimaging study: implantable pulse generators for pacemakers, defibrillator devices and most but not all spinal cord stimulators or deep brain stimulator, ferrous-containing metals within the body (e.g., braces, aneurysm clips, shrapnel/retained particles) inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia), weight > 300 lbs. unless height is sufficiently high [e.g., + 5'11"] so that waist and shoulder circumference do not prevent her from fitting in the scanner; opted out of cognition study, shift work
- Exclusion criteria for SKNA study only allergic to adhesive in electrode
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Paul C. Fitzgerald
Chicago, Illinois, 60611
About this study
Official title: Stellate Ganglion Blockade for the Management of Vasomotor Symptoms
Hot flashes and night sweats (vasomotor symptoms, VMS) affect 80% of women during the menopausal transition (MT). VMS are associated with decreased quality of life, increased depressive and anxiety symptoms, memory complaints, sleep disturbance, and reduced work productivity. Hormone therapy (HT) is highly effective in reducing VMS, but the use of HT declined 75% to 80% in the U.S. after the Women's Health Initiative (WHI) raised safety concerns about HT. In 2013, the Food and Drug Administration (FDA) approved paroxetine, a selective serotonin reuptake inhibitor (SSRI; 7.5 mg), as the first non-hormonal treatment for VMS. SSRIs are an important treatment option for many women, but their use in treating VMS is limited by lower effectiveness when compared to HT, side effects, and relapse of symptoms following treatment discontinuation. Identifying safe and effective non-hormonal treatments for VMS remains a priority in women's health research.
Stellate ganglion blockade (SGB), used for decades in pain management, is a potential new approach to VMS treatment. Located in the cervical spine region, the stellate ganglia are part of the sympathetic nervous system. Although SGB is commonly performed to treat neuropathic pain, hyperhidrosis or vascular insufficiency, anatomic studies reveal connections between this ganglion and thermoregulatory regions of the brain, specifically the insular cortex.
In this clinical trial, we aim to assess whether stellate ganglion block (SGB) with bupivacaine, a local anesthetic, is an effective and safe non-hormonal intervention for women seeking relief from vasomotor symptoms (VMS), and identify the physiologic mechanisms underlying SGB effects. Outcomes will include frequency and intensity of hot flashes, objectively-measured VMS, mood, quality of life, sleep, and memory performance in 160 postmenopausal women with 50 or more moderate to very severe hot flashes per week as measured by self-report for six months. They will be reassessed at 3 and 6 months following the SGB or a sham intervention for objective hot flashes and quality of life measures. Mechanistic outcomes (neuroimaging) will be obtained at baseline and 3 months following the intervention. Ambulatory monitoring of sympathetic nervous system function (SKNA) will be performed at baseline before the procedure, during the procedure and 1 hour following the procedure. This will be repeated at 2 and four weeks following the SGB or sham procedure for 1 hour recordings.
Read the detailed description
Scope:
Post-menopausal women with moderate to severe VMS will be enrolled as participants in this study.
Specific Goals and Objectives:
Primary Objective
- To determine the effect of SGB for reducing frequency and intensity of menopausal VMS. Hypothesis 1a. Seven-day mean frequency of VMS will be lower in women randomized to active SGB compared to sham control. Hypothesis 1b. Seven-day mean intensity of VMS will be lower in women randomized to active SGB compared to sham control. Hypothesis 1c. The VMS Intensity (Frequency*Severity), will be lower in women randomized to active SGB compared to sham control. Secondary Objectives
- To evaluate the effect of SGB on VMS Intensity, objective VMS, mood, memory, and sleep quality. Hypothesis 2a The frequency of objectively measured VMS will be lower in women randomized to active SGB compared to sham control. Hypothesis 2b. Depressive symptoms and memory, but not sleep quality, will improve more in women randomized to active SGB compared to sham control. Hypothesis 2c. The magnitude of improvements in memory will relate to the magnitude of reduction in VMS, even after controlling for sleep.
- To probe the mechanisms by which SGB improves VMS.
Hypothesis 3a. In a nested sub study, neuroimaging assessments will reveal that compared to sham control, active SGB is associated with a) decreased functional connectivity in the default mode network during the resting state, particularly for networks supporting the insula and hippocampus; b) reduced activation in the hippocampus, dorsolateral prefrontal cortex, and anterior cingulate during a verbal memory task; and c) reduced activation in the amygdala during an emotion processing task.
Hypothesis 3b. Compared to sham control, SGB will immediately diminish ipsilateral stellate ganglion nerve activity and sympathetic tone as measured by skin sympathetic nerve monitoring (SKNA) and these effects will be reassessed at 2 and 4 weeks after the intervention to assess if effects of SGB on stellate ganglion activity are long lasting.
- Conditions
- Hot Flashes, Hot Flushes, Vasomotor Symptoms
- Being tested
- Stellate Ganglion Block Injection with Bupivicaine, Saline injection
- Keywords
- Menopause, Post-menopausal
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate Ganglion Block Injection with BupivicaineDrug
Also called Marcaine
A computer-generated stratified randomization scheme by self-reported race and by etiology of menopause (natural versus surgical menopause) will be used to assign participants to receive either a SGB with bupivacaine or a sham injection with saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card.
Saline injectionDrug
Also called Sodium chloride solution
A computer-generated stratified randomization scheme by self-reported race and by etiology of menopause (natural versus surgical menopause) will be used to assign participants to receive either a SGB with bupivacaine or a sham injection with saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card.
| Study group | Role | What they receive |
|---|---|---|
| Bupivicaine | Active comparator | Stellate Ganglion Block injection with bupivicaine Receives: Drug: Stellate Ganglion Block Injection with Bupivicaine |
| Saline | Sham comparator | Saline injection Receives: Drug: Saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline and intensity of subjective hot flashes (HF)
Changes from baseline of paper diary (subjective) measures of frequency and intensity
Measured: Up to 24 weeks (6 months) following intervention
Secondary outcomes (8)
Changes from baseline of frequency of objective hot flashes
Changes from baseline frequency of objective HFs over a 24 hour period using a validated skin conductance monitor at baseline, 12 weeks (3 months) and 24 weeks (6 months)
Measured: Up to 24 weeks (6 months) following intervention
Composite changes from baseline of scores of neurocognitive measures
Composite changes from baseline of scores to include:California Verbal Learning Test (CVLT) List A, List B, Short-Delay Free Recall, Short-Delay Cued Recall, Long Delay Free Recall, Long Delay Cued Recall, Card Rotation Tests, Finding As, Letter, Semantic and Phonemic Fluency, Logical Memory Subtest of Wechsler Memory Scale (WMS-R/LM-R) Part 1 and (WMS-R/LM-R) Part 2, Mini-Mental State Exam (MMSE), Memory Functioning Questionnaire (MFQ),Closing Question at baseline, 12 weeks (3 months) and 24 weeks (6 months)
Measured: Up to 24 weeks (6 months) following intervention
Composite changes from baseline of scores of measures of mood
Composite changes from baseline of scores of mood to include: Beck Anxiety Inventory (BAI) and Center for Epidemiological Studies-Depression (CES-D) at baseline, 12 weeks (3 months) and 24 weeks (6 months)
Measured: Up to 24 weeks (6 months) following intervention
Composite changes from baseline of scores of measures of quality of life
Composite changes from baseline of scores of quality of life measures to include:Female Sexual Distress Scale (FSDS-R), Menopause Quality of Life Questionnaire (MENQUAL), Patient Global Impression of Change (PGIC), Utian Quality of Life Scale (UQOL), Hot Flash Related Daily Interference Scale (HFRDIS), PAIN Intensity and Interference Scale (PEG) Post Injection Questionnaire at baseline, 12 weeks (3 months) and 24 weeks (6 months)
Measured: Up to 24 weeks (6 months) following intervention
Changes from baseline of scores of measures of sleep
Composite changes from baseline of scores of Pittsburgh Sleep Quality Inventory (PSQI) and Insomnia Severity Index (ISI) at baseline, 12 weeks (3 months) and 24 weeks (6 months)
Measured: Up to 24 weeks (6 months) following intervention
Changes from baseline of actigraph measures of sleep
Changes from baseline of actigraph changes in sleep at baseline, 12 weeks (3 months) and 24 weeks (6 months)
Measured: Up to 24 weeks (6 months) following intervention
Changes from baseline of Skin Sympathetic Nerve Activity (SKNA)
Changes of recordings of SKNA using an FDA-approved, specially-configured portable device (Biomation ME6000) in a subset of 60 participants
Measured: Up to 2 and 4 weeks following intervention
Changes from baseline of Functional MRI
Changes in fmri activity in a subset of 60 participants at baseline and 3 months following the intervention
Measured: Up to 12 weeks following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start10 Jul 2018
- Primary completion24 Aug 2023
- Study completion24 Aug 2023
Why it stopped: Audit panel terminated IRB approval and closed the study study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago, Indiana University
- Responsible party
- Sponsor
- Investigators
- Charles W Hogue, MD, Study chair, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907983
- Sponsor's protocol ID
- STU00203490
- Acronym
- R01
- Status last verified
- Jul 2025
- First submitted
- 16 Sep 2016
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stellate Ganglion Blockade for the Management of Vasomotor Symptoms
- ClinicalTrials.gov ID
- NCT02907983
- Acronym / sponsor ID
- R01 / STU00203490
- Conditions
- Hot Flashes, Hot Flushes, Vasomotor Symptoms
- Keywords
- Menopause, Post-menopausal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Audit panel terminated IRB approval and closed the study study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Illinois Chicago, Indiana University
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 20 Sep 2016 (estimated)
- 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.
Hot flashes and night sweats (vasomotor symptoms, VMS) affect 80% of women during the menopausal transition (MT). VMS are associated with decreased quality of life, increased depressive and anxiety symptoms, memory complaints, sleep disturbance, and reduced work productivity. Hormone therapy (HT) is highly effective in reducing VMS, but the use of HT declined 75% to 80% in the U.S. after the Women's Health Initiative (WHI) raised safety concerns about HT. In 2013, the Food and Drug Administration (FDA) approved paroxetine, a selective serotonin reuptake inhibitor (SSRI; 7.5 mg), as the first non-hormonal treatment for VMS. SSRIs are an important treatment option for many women, but their use in treating VMS is limited by lower effectiveness when compared to HT, side effects, and relapse of symptoms following treatment discontinuation. Identifying safe and effective non-hormonal treatments for VMS remains a priority in women's health research.
Stellate ganglion blockade (SGB), used for decades in pain management, is a potential new approach to VMS treatment. Located in the cervical spine region, the stellate ganglia are part of the sympathetic nervous system. Although SGB is commonly performed to treat neuropathic pain, hyperhidrosis or vascular insufficiency, anatomic studies reveal connections between this ganglion and thermoregulatory regions of the brain, specifically the insular cortex.
In this clinical trial, we aim to assess whether stellate ganglion block (SGB) with bupivacaine, a local anesthetic, is an effective and safe non-hormonal intervention for women seeking relief from vasomotor symptoms (VMS), and identify the physiologic mechanisms underlying SGB effects. Outcomes will include frequency and intensity of hot flashes, objectively-measured VMS, mood, quality of life, sleep, and memory performance in 160 postmenopausal women with 50 or more moderate to very severe hot flashes per week as measured by self-report for six months. They will be reassessed at 3 and 6 months following the SGB or a sham intervention for objective hot flashes and quality of life measures. Mechanistic outcomes (neuroimaging) will be obtained at baseline and 3 months following the intervention. Ambulatory monitoring of sympathetic nervous system function (SKNA) will be performed at baseline before the procedure, during the procedure and 1 hour following the procedure. This will be repeated at 2 and four weeks following the SGB or sham procedure for 1 hour recordings.
Detailed description
Scope:
Post-menopausal women with moderate to severe VMS will be enrolled as participants in this study.
Specific Goals and Objectives:
Primary Objective
- To determine the effect of SGB for reducing frequency and intensity of menopausal VMS. Hypothesis 1a. Seven-day mean frequency of VMS will be lower in women randomized to active SGB compared to sham control. Hypothesis 1b. Seven-day mean intensity of VMS will be lower in women randomized to active SGB compared to sham control. Hypothesis 1c. The VMS Intensity (Frequency*Severity), will be lower in women randomized to active SGB compared to sham control. Secondary Objectives
- To evaluate the effect of SGB on VMS Intensity, objective VMS, mood, memory, and sleep quality. Hypothesis 2a The frequency of objectively measured VMS will be lower in women randomized to active SGB compared to sham control. Hypothesis 2b. Depressive symptoms and memory, but not sleep quality, will improve more in women randomized to active SGB compared to sham control. Hypothesis 2c. The magnitude of improvements in memory will relate to the magnitude of reduction in VMS, even after controlling for sleep.
- To probe the mechanisms by which SGB improves VMS.
Hypothesis 3a. In a nested sub study, neuroimaging assessments will reveal that compared to sham control, active SGB is associated with a) decreased functional connectivity in the default mode network during the resting state, particularly for networks supporting the insula and hippocampus; b) reduced activation in the hippocampus, dorsolateral prefrontal cortex, and anterior cingulate during a verbal memory task; and c) reduced activation in the amygdala during an emotion processing task.
Hypothesis 3b. Compared to sham control, SGB will immediately diminish ipsilateral stellate ganglion nerve activity and sympathetic tone as measured by skin sympathetic nerve monitoring (SKNA) and these effects will be reassessed at 2 and 4 weeks after the intervention to assess if effects of SGB on stellate ganglion activity are long lasting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivicaine | Active comparator | Drug: Stellate Ganglion Block Injection with BupivicaineStellate Ganglion Block injection with bupivicaine |
| Saline | Sham comparator | Drug: Saline injectionSaline injection |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- post-menopausal woman defined according to the following criteria: 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels ≥ 40 IU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy
- aged 40 to 70 years
- 50 or more reported moderate-to-severe hot flashes per week
- a minimum of two weeks of VMS diary recording prior to SGB
- post-menopausal women whose vasomotor symptoms are refractory to approved oral treatments (i.e., hormone therapy or paroxetine) or for whom hormone therapy is contraindicated or for women who refuse any oral therapy
Key exclusion criteria (8 listed)
- conditions that preclude SGB or sham intervention (e.g., anatomic abnormalities of the anterior neck or cervical spine ; goiter, cardiac/pulmonary compromise; contralateral (left-sided) phrenic nerve paralysis or diaphragmatic paresis; history of seizure, coma, or stroke; history of neurologic deficit to the brachial plexus or an abnormal brachial plexus neurologic exam; history of Zenker's diverticulum; acute illness/infection; coagulopathy or bleeding abnormalities; INR >1.3; hemoglobin<9.0, platelets <100,000, BUN ≥ 30mg/dl; creatinine ≥ 2 mg/ml; ALT (SGPT), AST (SGOT), Alk Phos ≥ three times the upper limit of normal; serum potassium (K+) ≤ 3.5 or ≥ 5.0 mEq/L allergic reactions or contraindications to a local anesthetic or contrast dye, systolic blood pressure (SBP) >140 mm Hg or diastolic blood pressure (DBP) >90 mm Hg, pregnancy
- If LMP is between 6 to 12 months, FSH < 40
- use of treatments less than the washout period and throughout study participation that can affect VMS frequency or severity, including oral (2 months) or transdermal hormone therapy(1 month), botanicals (e.g., soy, red clover, black cohosh, etc.)(1 month), oral contraceptives(2 months), serotonin selective reuptake inhibitors (SSRI) (2 weeks), serotonin norepinephrine reuptake inhibitors (SNRI),( 2 weeks) gabapentin, pregabalin, clonidine, selective estrogen receptor modulators, aromatase inhibitors, tissue selective estrogen complexes;(2months)
- use of aspirin and non-steroidal anti-inflammatory medications for 3 days prior to the SGB procedure; all other anti-platelet or anticoagulation medications will be discontinued with the permission of the participant's prescribing physician
- for cognition testing: conditions or disorders that can affect performance on cognitive tests (e.g., dementia/mild cognitive impairment, Mini-Mental State Exam (MMSE) less than or equal to 27) at baseline; stroke; traumatic brain injury; alcohol/substance use; inability to write, speak, or read in English, English as a second language, participation in other studies involving tests of cognitive abilities,
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 |
|---|---|---|
| Stellate Ganglion Block Injection with BupivicaineAlso: MarcaineA computer-generated stratified randomization scheme by self-reported race and by etiology of menopause (natural versus surgical menopause) will be used to assign participants to receive either a SGB with bupivacaine or a sham injection with saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card. | Drug | Bupivicaine |
| Saline injectionAlso: Sodium chloride solutionA computer-generated stratified randomization scheme by self-reported race and by etiology of menopause (natural versus surgical menopause) will be used to assign participants to receive either a SGB with bupivacaine or a sham injection with saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card. | Drug | Saline |
Primary outcome
Changes from baseline and intensity of subjective hot flashes (HF)
Time frame: Up to 24 weeks (6 months) following intervention
Changes from baseline of paper diary (subjective) measures of frequency and intensity
8 secondary outcomes
Changes from baseline of frequency of objective hot flashes
Time frame: Up to 24 weeks (6 months) following intervention
Composite changes from baseline of scores of neurocognitive measures
Time frame: Up to 24 weeks (6 months) following intervention
Composite changes from baseline of scores of measures of mood
Time frame: Up to 24 weeks (6 months) following intervention
Composite changes from baseline of scores of measures of quality of life
Time frame: Up to 24 weeks (6 months) following intervention
Changes from baseline of scores of measures of sleep
Time frame: Up to 24 weeks (6 months) following intervention
Changes from baseline of actigraph measures of sleep
Time frame: Up to 24 weeks (6 months) following intervention
Changes from baseline of Skin Sympathetic Nerve Activity (SKNA)
Time frame: Up to 2 and 4 weeks following intervention
Changes from baseline of Functional MRI
Time frame: Up to 12 weeks following intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
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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.
Charles W Hogue, MD study chair
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stellate Ganglion Block Injection with Bupivicaine and Saline injection in people with Hot Flashes and Hot Flushes, run by Northwestern University at 2 sites in United States.
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 7 inclusion and 8 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: withdrawn, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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?
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Changes from baseline and intensity of subjective hot flashes (HF) (time frame: Up to 24 weeks (6 months) following intervention). 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 23 Jul 2025.