One thing that I am very proud of here at The Vajenda is how responsive the community has been in enrolling in and promoting the medical studies I have shared. Two doctors from two different studies have previously thanked me and the Vajenda community because their studies filled up faster than expected, which they attributed to posts here on The Vajenda.

We should all be angry about the systemic underfunding of women’s health, but we can put that anger into action by supporting good studies that are trying to recruit participants. It is a sad truth that many studies have a harder time recruiting women, often because women have greater caregiving responsibilities than men and because of fear of side effects and distrust (completely valid). When I first learned that studies looking to recruit women were more likely to struggle, I decided to do my part and promote good studies that might connect with my audience here.

This new study involves testing a home transcutaneous auricular neurostimulation device to reduce heavy menstrual bleeding. I saw it promoted by a hematologist whom I trust and respect on BlueSky, and decided to read more, because I was fascinated by the proposed biological connection that stimulating the vagal nerve could reduce menstrual bleeding, and because women need more options for heavy bleeding.

The Vagal Nerve and Blood Clotting

The hypothesis is built on preclinical work showing that vagus nerve stimulation modifies platelet function and improves clotting. In a pig model, electrical vagus nerve stimulation reduced the time it took to stop bleeding from a wound by about 43% and total blood loss by about 46%.

The main theory behind the connection to blood clotting is that vagal nerve stimulation signals the spleen, where immune cells release acetylcholine. This acetylcholine binds to receptors on platelets, increasing calcium influx and making the platelets more responsive to clotting at bleeding sites, which could reduce menstrual bleeding. Basically, vagal nerve stimulation makes stickier platelets.

What Evidence Do We Have?

There has already been a Phase I study, which was an open-label pilot trial (NCT06064851) of a wearable transcutaneous auricular neurostimulation (tAN) device. The device targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN), a branch of the trigeminal nerve.

As this was an open-label study, this means the women were using the device, they knew they were using it, and there was no control group.

The trial enrolled 16 women with heavy menstrual bleeding: 8 with von Willebrand disease (VWD, a bleeding disorder), and 8 with heavy bleeding of unknown cause. Each participant served as her own control: one baseline menstrual cycle was measured using a validated self-completed blood loss assessment chat, the PBAC, followed by one treatment cycle. The intervention was self-administered 1-hour sessions twice a day during menstruation.

The results were impressive:

• 57% lower PBAC scores in the VWD cohort

• 54% lower PBAC scores in the unexplained HMB cohort

• 19% reduction in menstruation duration in both groups

• There was also was a reduction in cramps, pain, and fatigue, with improved quality of life scores

This is exciting, but it is also extremely preliminary data with significant limitations.

It was an open-label study, so the women knew they were using the device, because of this, as the bleeding measure was self-reported, the results are susceptible to placebo and expectation bias. Also, there were only 16 participants and each participant compared only two menstrual cycles; there are significant normal cycle-to-cycle variations in menstrual blood loss, so a single comparison cycle is not enough to say the device works, but it is enough to justify the investment for a Phase 2 study. Also, the 54–57% reduction is a pretty large success rate, so that raises some skepticism. But who knows? That is why we use this data and move to the next level of research to find out.

I point this out not to discourage anyone, but to explain that a Phase 1 study is just that. A fact-finding mission. It is the first step on a long road and responsible researchers don’t jump from this point to proclaiming they have a solution on social media. The goal was to identify a signal, and that was achieved. The next step is a more robust Phase II study to determine whether the signal persists. And, quite frankly, it’s nice to see a device company doing it the right way.

Which Leads Us to the New Study

It is called Delivering tAN to Reduce HMB: The LUNA Study (LUNA). The clinical trial number is NCT07326722, and it can be found here.

The LUNA study is a randomized, double-blind, sham-controlled, clinical trial for participants with heavy menstrual bleeding who don’t have fibroids or any known conditions that affect the uterus as a cause. The study divides participants into two cohorts based on age: adolescents aged 14-21 and adults aged 22-45.

The intervention is transcutaneous auricular neurostimulation (tAN), or sham stimulation. The study will run over five menstrual cycles, and it is remote, so no in-person visits are needed. Blood loss is assessed using the self-administered Pictorial Bleeding Assessment Chart (PBAC), and information on pain and other menstrual symptoms, as well as quality of life, will also be collected.

There will be two run-in menstrual cycles without intervention, followed by three consecutive cycles of either one 2-hour sham or active tAN session daily, beginning on Day 1 of menstruation and continuing through the final day of each menstrual cycle.

Here are the eligibility criteria:

• Regularly menstruating females aged 14-45 years

• History of heavy periods (there are specific criteria to meet)

• Stable/consistent use of current non-hormonal medications and supplements for the past three months, willingness to continue use for the duration of the study, and not start any new medications or homeopathic remedies

• Reliable access to an internet-enabled device to complete required questionnaires that is compatible with the study application (iOS 18 and Android 15 or greater)

• Willingness to consistently use only study-provided menstrual products throughout the duration of the study

• Participant PBAC scores are ≥150 for both baseline menstruation months (if someone doesn’t have heavy bleeding during the run in months it makes sense that they can’t participate).

Bottom Line

The concept is biologically plausible based on animal data and the first human trial. This tells us that it is worth moving to the next study, and that is what is happening. We should celebrate this. It’s a big deal to have investment in non medication approaches to heavy periods. Considering the magnitude of the problem, the more options we have for women, the better. And who knows, if the device does prove effective, there could be other applications. Good research can lead in all kinds of directions.

If you have heavy menstrual bleeding, are interested, and think you qualify, consider exploring the study (and let them know who sent you). If this isn’t the study for you, please do share with your friends. They need eighty participants, so let’s help them fill the study!

Here is the study contact information:

Name: Laura Mitchell

Phone Number: (844) 534-9716

Email: <a href="mailto:LUNA@lindushealth.com">LUNA@lindushealth.com</a>

And the flyer, although I couldn’t get the think the link or QR code works.

References

1. Czura CJ, Schultz A, Kaipel M, et al. Vagus Nerve Stimulation Regulates Hemostasis in Swine. Shock. 2010.

2. Czura CJ, Weyand AC, Baldwin MK, et al. Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Women With and Without Von Willebrand Disease. Frontiers in Medicine. 2025.

Last week, the Trump administration quietly released a sweeping new federal rule that would use funding threats to force institutions across the country to reject transgender people. The 400-page proposed regulation would codify the administration's anti-trans executive orders into binding federal policy, imposing a blanket prohibition on federal funds going toward "gender ideology"—with terms broad enough to encompass any acknowledgment that gender identity differs from sex assigned at birth or that transgender people even exist. If finalized, the rule would reach every hospital, university, school district, state government, nonprofit, and homeless shelter that receives federal funding, effectively requiring much of American institutional life to discriminate against transgender people as a condition of receiving federal money. And unlike an executive order, the rule would require significant work by a future administration to reverse.

The proposed rule, formally titled "Regulation for Federal Financial Assistance," rewrites the government-wide framework governing all federal grants across every agency. Among its most consequential provisions, it requires that before a federal grant recipient can receive money, the award must pass a "pre-issuance review" conducted by a political appointee—not a career expert or peer reviewer—to ensure it is "consistent with applicable law, Federal agency priorities, and the national interest." The regulation explicitly instructs these appointees to screen for "denial by the recipient of the sex binary in humans or the notion that sex is a chosen or mutable characteristic." The word "recipient" is doing critical work here: the review evaluates the organization, not just how the grant money will be spent. An institution that acknowledges transgender people exist—through its policies, its training, its healthcare, its bathroom access, its HR procedures, its name-change processes—could be deemed to "deny the sex binary" or to “support the notion that sex is mutable” and have its federal funding blocked. For grants that have already been issued, provisions also allow for the termination of funding.

The prohibition is vast. The rule bars federal awards from being used to "fund, promote, encourage, subsidize, or facilitate" gender ideology—and as mentioned before, because the screening evaluates the recipient as a whole, even indirect support could trigger enforcement. Since the rule was published, Erin in the Morning has been contacted by those worried about its impact on homeless shelters, which could be required to turn transgender people—any acknowledgment of a resident's gender identity could be grounds for a funding investigation. Colleges and universities, among the largest recipients of federal grants in the country, would face renewed federal pressure to enact bathroom bans, sports bans, and restrictions on name and gender marker changes—any institutional process that recognizes a gender identity different from sex assigned at birth could be deemed "gender ideology." Nonprofits and federally qualified health centers could be forced to stop acknowledging that transgender people exist entirely or serving their needs—a step some organizations briefly took during the chaos of the initial executive orders before pulling back when courts and advocates signaled they lacked enforceability. This rule is designed to give them enforceability.

Importantly, the gender ideology prohibition has no age limitation—hospitals could be targeted not just for providing care to minors but for providing gender-affirming care to adults, because prescribing hormone therapy to a transgender patient of any age could be deemed promoting the belief that "sex is a chosen or mutable characteristic." The Trump administration has already used funding threats and federal subpoenas to target hospitals providing gender-affirming care to transgender youth, a campaign that caused multiple institutions to suspend their programs even before any legal determination was made. The extraordinary broadness of the "gender ideology" definition—which covers not just care for minors but any endorsement of the idea that “sex is mutable”—would give the administration the regulatory infrastructure to expand that targeting to care for transgender adults if it so chose.

The rule was jointly proposed by 42 federal agencies—from the Department of Health and Human Services to the Department of Defense to the National Science Foundation to NASA—each of which signed the document through its senior leadership. Signatories include Robert F. Kennedy Jr. at HHS, Kelly Loeffler at the Small Business Administration, and Troy Edgar at the Department of Homeland Security. It is the broadest interagency rulemaking effort of the Trump administration, and it is designed to ensure that no single agency can opt out or slow-walk implementation.

The Human Rights Campaign, the nation's largest LGBTQ+ rights organization, came out fiercely against the rule, calling it "fascism." In a statement, the organization said: "Today, the Trump administration proposed a rule that would strip government money from any program that acknowledges diversity, abortion, or even the existence of transgender and nonbinary people. Withholding public grants from programs that depend on them because you refuse to acknowledge the humanity of certain communities is not good government. It's fascism. HRC and our millions of members, supporters, and allies will fight back."

The gender ideology funding prohibition is not the only provision targeting transgender or LGBTQ+ people. A separate section prohibits any federal funding for "the so-called 'transition' of a child under 19 years of age from one sex to another, including the chemical and surgical mutilation of children.” The rule also explicitly strips Bostock v. Clayton County, the landmark 2020 Supreme Court decision holding that sex discrimination includes discrimination based on gender identity, from the federal grants framework entirely. The preamble states that the prior administration's reading of Bostock is "no longer consistent with Administration policy" and replaces it with reasoning drawn from United States v. Skrmetti, the 2025 decision upholding Tennessee's ban on gender-affirming care for minors, to argue that none of these provisions constitute sex discrimination because they "apply equally to all."

The administration has tried to strip federal funding from organizations that support transgender people before, leading to a string of court losses. But those losses have not prevented organizations from overcomplying out of fear. The National Center for Missing and Exploited Children, the country's primary nonprofit fighting child sexual exploitation, erased all references to transgender people from its public materials after the Department of Justice threatened to pull its funding—and was told to deadname transgender children in its missing persons reports, meaning a missing trans girl would be listed under her birth name and identified as male, actively making her harder to find. RAINN, the nation's largest anti-sexual-violence organization, removed its inclusion policy and all pages expressing support for LGBTQ+ survivors of sexual violence—a population that faces disproportionately high rates of assault. And using similar threats, more than 40 hospitals have stopped providing gender-affirming care to transgender youth, suspending programs even in states where the care remains legal. This latest effort to formalize the policy into binding federal regulation is designed to insulate it from such court challenges, and we could see an entirely new round of even broader overcompliance as a result.

Nevertheless, court challenges are almost certainly coming, and the rule has a substantial likelihood of being blocked for at least a short amount of time. That said, the Supreme Court has greenlit virtually every policy targeting transgender people to come across its docket, and this rule could be the next one that rockets its way to the top. The public comment period closes July 13, 2026. Concerned readers can submit comments on the public comment page for the rule.