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A “First-In-Woman” Study: Tampon-Based Drug Delivery Device Enters Clinical Trials

Tulips, a pregnancy test, and a pacifier laid on a pink background.
Credit: Nataliya Vaitkevich / Pexels.
Read time: 5 minutes

Unfortunately, miscarriage is a common complication in pregnancy.


One in four women will experience miscarriage, and it is estimated to occur in 8–24% of pregnancies. However, the true incidence is likely much higher, as many women face losses before realizing they are pregnant.


Some women may experience symptoms including vaginal bleeding and abdominal pain, early in pregnancy. This is known as threatened miscarriage.


Once confirmed as having a threatened miscarriage, women are often reassured that their chances of a healthy, ongoing pregnancy are “good”, as most pregnancies do continue.


Yet, in the days and weeks that follow, they must face the anguish of not knowing which set of odds they fall into, while also navigating care that prioritizes clinical protocols over patient perspective. The same experience rings true for women struggling with infertility, where the inability to achieve a successful pregnancy is not only a medical challenge but an emotional one as well.


Dr. Lara Zibners and Thang Vo-Ta, co-founders of Calla Lily Clinical Care (CLCC), recognize this imbalance all too well. The duo sat down with Technology Networks to share their motivations for improving fertility care and the rationale behind their novel intravaginal drug delivery platform, currently in a phase 1 study with luteal phase insufficiency patients, which they hope will improve care for threatened miscarriage and infertility.

Izzy Hirst (IH):

What experiences led each of you to focus on intravaginal drug delivery and, specifically, its potential role in fertility care?


Lara Zibners, MD (LZ):

My personal experience with infertility and the trauma compounded by the way certain drugs are delivered very much drives our mission today.


No one decides they are going to fail seven rounds of IVF and then go start a women’s healthcare company, but that is exactly what happened.


Vaginal drug delivery is the right drug in the right place, but when it leaks, and you aren’t certain the medication is doing its job, there is a tendency to jump to very painful progesterone injections. At the time, I put up with it. But now I can do something about it.



Thang Vo-Ta (TVT):

I’ve been in the women’s health space for nearly a decade, and the motivation is both professional and deeply personal. As a husband and father of two daughters, I want to help build a healthcare system that better serves women.


When the UK National Institute for Health and Care Excellence (NICE) guidance on miscarriage prevention using vaginal progesterone was introduced in 2021, Lara and I saw the potential for our underlying technology to offer a better way to deliver medication: one that could be more comfortable, more convenient, and more aligned with women’s real lives. With my background in finance and company-building, and Lara’s lived patient experience, it felt like the right time to focus our efforts on a very significant unmet need.



IH:

Can you explain the role of progesterone in supporting fertility and why it is used in the treatment of threatened miscarriage?


LZ:

Progesterone is a hormone that the body makes naturally to support a healthy pregnancy, from conception to delivery. In some women, not enough of the hormone is produced in the early stages of pregnancy. This can create a uterine environment that isn’t ready to support healthy implantation of an embryo.


By providing additional progesterone early in pregnancy, the embryo has a better chance of taking root and leading to a full-term baby. No one knows exactly why some women need progesterone support, and it won’t prevent all miscarriages, but it’s one answer in a complex series of questions. 



TVT:

Progesterone supplementation has long played an important role in assisted reproduction and preterm birth prevention, and now in miscarriage care. The NICE guidance in the UK, which has expanded to other countries, recommends up to 80 days of vaginal progesterone for women with certain risk factors for miscarriage.


This recommendation was largely based on the PRISM clinical trial. The data suggested a benefit in some women with a history of recurrent pregnancy loss. Very fortunately for us, one of the authors of those studies, Professor Siobhan Quenby MBE, has been a long-time clinical advisor of CLCC. 


PRISM trial results

Progesterone did not improve live birth rates in the overall trial population; subgroup analysis indicated a possible benefit among women with a history of three or more previous miscarriages. In this subgroup, the live birth rate was 72% with progesterone compared with 57% on placebo. 



IH:
What limitations of existing vaginal delivery methods informed the design of Callavid®?

LZ:

There are existing vaginal delivery methods that don’t cause leakage and dosage uncertainty, such as a vaginal ring and intrauterine devices. However, these devices aren’t appropriate for luteal phase support. To achieve high enough doses, a vaginal gel or pessary is prescribed, both of which are notoriously unpleasant to use. Additionally, some women are advised by their clinician to lie down for a minimum of 20–30 minutes after insertion.


We are able to adapt our device so that only the inactive ingredients and any additional discharge are absorbed, while the active medication reaches the rich vasculature of the reproductive tract.



TVT:

Our Callavid® device is built around a 100% cotton tampon. However, to effectively deliver medication, it isn’t just cotton. The tampon portion is specially modified so that it won’t absorb any of the medication, only vaginal discharge. This is connected by a very thin medical grade polymer membrane that keeps the finger clean upon insertion and removal. The sheath is connected to a small liner that remains external to the body. This is shaped to fit a woman’s anatomy precisely while absorbing inactive ingredients and any additional leakage. 



IH:
How does moving a drug–device combination into a clinical trial differ from evaluating a drug alone, especially when the drug is already approved for use, and how did this shape the FREEDOM study?

LZ:
In our case, we aren’t inventing a new drug. Therefore, the FREEDOM study is designed to show safety when progesterone is delivered using the Callavid device. This will be followed by our pivotal study to show our device is not only safe but also delivers the same amount of drug to the body as the existing vaginal progesterone products.


TVT:
We are incredibly excited to have the National Institute of Health and Care Excellence (NIHR) funding our FREEDOM study. This is a huge vote of confidence from the UK government, which is placing renewed focus on women’s health. This is a first-in-woman study and is the first required step in achieving full MHRA approval. Importantly, patient input from existing recurrent miscarriage patients at the University Hospitals Coventry and Warwickshire, where the study is taking place, was crucial to the design of the trial.


IH:
How readily could a platform like Callavid be adapted for other women’s health applications, and what would that process look like?

LZ:
The beauty of Callavid is that we can adapt it to the needs of any therapeutic while making changes to the device that allow for selective absorption of only the inactive ingredients and associated leakage. For progesterone, considerations included the hard fat base that the drug is mixed into and the amount of additional leakage that specifically results from progesterone absorption. Other drugs come in a water- or gel-based formulation, some create more or less leakage, some require very careful insertion without any contamination from fingers. Our device can account for all these needs. 


TVT:
What’s wonderful about the team at CLCC is just that, the team. We have seven PhDs working in our labs, each with a different background. Our principal scientist, Prof. Andy Lewis, is a drug device expert with over 55 patents. He also happens to have worked on tampon development in a past life. Under his guidance, the team has the skills and knowledge to fully explore the best way to integrate new drugs onto our device. 


IH:
With many established medicines approaching the patent cliff, what role can drug–device combination products play in extending the clinical and commercial value of existing therapies?

TVT:
It’s important that we think of Callavid not just as a way to extend the patent life of established medications, although the 2026–27 patent cliff is looming. We are committed to offering pharmaceutical companies an integration that is not only protected from an intellectual property standpoint but is actually a better way of delivering medication for women. For example, research has shown more stable absorption or better local effectiveness for some medications when delivered vaginally. Yes, this does offer a commercial value to our partners, but it’s not our only consideration. 


LZ:

What is unique about drug–device combinations is the opportunity to create value around existing drugs that may have lost their luster due to a lack of patent protection. Consider the vaginal microbiome. Live biotherapeutics (good bacteria) can’t easily be patented, but the design of a device and the way in which therapeutics are delivered to ensure effectiveness can. This might incentivize pharmaceutical companies to revisit effective drugs that weren’t previously thought of as having commercial value. 



IH:
Looking ahead, what unmet needs in women’s health do you think could benefit from advances in intravaginal drug delivery platforms like Callavid?

LZ:
Imagine a world where medicine works for you. As in not just generally, but specifically, you. We see a future where precision medicine defines not only the types of medications that would be beneficial, but also the formulations and dosages that match a woman’s unique physiology. Callavid does two things for the future of intravaginal drug delivery. First, it opens the imagination. The science has always been there, but innovation has been lacking. Secondly, we have designed our device to fit a woman’s physiology, anatomy, and lifestyle; her wellbeing. There could be a day when Callavid is loaded with just the right amount of the right drug for the right woman. 


TVT:

There are so many ways in which Callavid can advance women’s health. Cancers of the reproductive tract come to mind. Delivery devices could provide targeted therapy that delivers powerful, next-generation medicines directly to the cervix, endometrium, or ovaries.


But the bigger opportunity is personalized women’s healthcare. Callavid has potential not only as a delivery platform, but also as a diagnostic and sample-collection technology. Building on what Lara said, imagine a world where a woman can collect a sample herself, send it for analysis, and then receive the right medicine, at the right dose, delivered in a way that fits her body and her life.


As a father of daughters, that future feels very personal to me. But more importantly, it is the kind of future all women deserve: more precise and more patient-centered. 


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