Phentolamine + Propranolol for Menopause

Overseen By Jacqueline Limberg, PhD

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: University of Missouri-Columbia

Must not be taking: Prescription medications

Disqualifiers: Pregnancy, Smoking, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two treatments, phentolamine (an injection) and propranolol (a type of beta-blocker), affect the nervous and circulatory systems in women experiencing menopause. Researchers aim to understand why women face higher risks of heart-related issues as they age. The trial suits women assigned female at birth who are not overweight (BMI under 30) and do not have major health conditions like high blood pressure or diabetes. As an Early Phase 1 trial, this research focuses on understanding how these treatments work in people, offering participants a chance to contribute to groundbreaking insights.

Will I have to stop taking my current medications?

Yes, participants must stop taking prescription medications to join this trial.

Is there any evidence suggesting that Phentolamine Injection and Propranolol Hydrochloride are likely to be safe for humans?

Research has shown that phentolamine is generally safe for approved uses, such as managing sudden increases in blood pressure. It widens blood vessels to improve blood flow. Most people tolerate it well, though it can cause minor side effects like tingling when injected in certain areas.

Propranolol is another well-known medication, often used to treat high blood pressure and heart issues. This drug is widely prescribed and usually well-tolerated. However, individuals with certain heart conditions or asthma should avoid it, as it can worsen these conditions.

Both medications have been used for a long time, suggesting they are safe for most people. However, since this trial is in an early stage, the safety of the treatment for menopause remains under study. Participants should consult their doctor about any potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Phentolamine and Propranolol for menopause because it offers a unique approach compared to standard treatments like hormone replacement therapy. Unlike traditional methods that focus on adjusting hormone levels, Phentolamine works by blocking alpha-adrenergic receptors, which can help manage symptoms like hot flashes. Propranolol, a beta-blocker, may help reduce anxiety and other cardiovascular symptoms associated with menopause. This combination targets both vascular and nervous system symptoms, potentially offering a more comprehensive relief for menopausal women.

What evidence suggests that Phentolamine and Propranolol might be effective treatments for menopause?

This trial will evaluate the effects of both propranolol and phentolamine on menopause symptoms. Studies have shown that propranolol can reduce the number and intensity of hot flashes in menopausal women. In one study, propranolol proved more effective than a placebo in relieving these symptoms. Conversely, phentolamine primarily treats high blood pressure in specific situations, and little research exists on its effectiveness for menopause symptoms. A previous study examined phentolamine in postmenopausal women, but the results were inconclusive for this purpose. Overall, propranolol has more evidence supporting its use for menopause relief, while the role of phentolamine remains uncertain. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals assigned female at birth, going through menopause, and with a body mass index (BMI) less than 30 kg/m2. It aims to understand the increased cardiovascular risk in aging women.

Inclusion Criteria

My BMI is below 30.

I was assigned female at birth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Study Visit

Participants undergo assessments of sympathetic transduction, blood flow, and muscle sympathetic nerve activity

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the study visit

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Phentolamine Injection
• Propranolol Hydrochloride

Trial Overview The study tests how the sympathetic nervous system interacts with blood vessels during menopause by using Phentolamine Injection and Propranolol Hydrochloride.

How Is the Trial Designed?

Group I: Women Experimental Treatment 2 Interventions

Women ages 18-70 years will participate.

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1471769704000024

Treatment of female sexual dysfunction in postmenopausal ... Hormone replacement therapy with estrogens improves vasomotor symptoms, vaginal dryness, dyspareunia and general well-being, yet in most women has little effect ...

2. go.drugbank.com go.drugbank.com/drugs/DB00692

Phentolamine: Uses, Interactions, Mechanism of Action Phentolamine is used to prevent or control hypertensive episodes that may occur in a patient with pheochromocytoma due to stress or manipulation.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2015/429713

Endogenous Estrogen‐Mediated Heme Oxygenase ... We also found that the cardiac LV levels of IL-6 and TNF-α were significantly reduced after ovariectomy and the menopause. An estrogen ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9126898/

The Efficacy and Safety of Selective Serotonin Reuptake ... Studies have shown that short-term hormone therapy (HT) is the most effective treatment for HF in perimenopausal and postmenopausal women. HT reduces HF ...

5. mdpi.com mdpi.com/2411-5118/6/3/38

Advancing Women's Health: A Scoping Review of ... It has limited data supporting it as a treatment for FSD. A 2002 clinical trial investigated the effects of phentolamine in 41 postmenopausal women with ...

6. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9WEST_PHENTOLAMINE_MESYLATE_VL_5MG_2ML_1CT.pdf

SAFETY DATA SHEET P302 + P352 + P362+P364 - IF ON SKIN: Wash with plenty of soap and water. Take off contaminated clothing and wash it before reuse.

7. oraverse.com oraverse.com/assets/pdf/MSDS.pdf

MATERIAL SAFETY DATA SHEET - OraVerse Health Hazards: Avoid ingestion and systemic absorption. Avoid contact with eyes or skin. Phentolamine is an adrenergic blocker; target organs ...

8. mayoclinic.org mayoclinic.org/drugs-supplements/phentolamine-injection-route/description/drg-20065481

Phentolamine (injection route) - Side effects & dosage Phentolamine given by injection causes blood vessels to expand, thereby increasing blood flow. When injected into the penis (intracavernosal), it increases ...

9. drugs.com drugs.com/sfx/phentolamine-side-effects.html

Phentolamine Side Effects: Common, Severe, Long Term Phentolamine injected into the penis may cause tingling at the tip of the penis. This is no cause for concern.