Progesterone support, reimagined

 

How rethinking progesterone delivery could ease the daily burden of fertility treatment for patients worldwide.

Innovation in women’s health rarely begins with a breakthrough moment. More often, it starts quietly – with something that feels uncomfortable, inefficient, or simply taken for granted. In fertility care, one of those overlooked realities is in the delivery of progesterone. Around most of the world, vaginal progesterone is used to support early pregnancy, prevent miscarriage, and reduce the risk of preterm birth. In the US, however, many women still endure progesterone-in-oil injections: viscous, painful shots that linger in memory long after treatment ends.

For Lara Zibners, the co-founder of Calla Lily, this was a lived experience. Years after completing several rounds of IVF, she found herself discussing new NICE guidance in the UK, recommending extended progesterone use for women at risk of miscarriage. At that moment, the disconnect between what patients endured and what medicine accepted as routine became impossible for her to ignore.

Progesterone leakage is not a footnote – it shapes how women organise their days, how long they lie down after dosing, how they interpret discharge when already anxious about miscarriage, and how they navigate fertility treatment while working or caring for children. Yet, the impact of the issue rarely makes it into consultations, clinical papers, or funding conversations. Leakage is treated as bothersome, but tolerable, an uncomfortable price that women should quietly pay on their path to pregnancy.

Calla Lily’s work begins there – with a deceptively simple question: why hasn’t anyone fixed this? To learn more, Deep Dive sat down with Zibners to discuss the overlooked realities of progesterone delivery treatment and the broader potential of a vaginal drug delivery platform.

The overlooked problem

 

What made you realise that the standard approach to fertility-related progesterone wasn’t just imperfect, but fundamentally flawed?

“It wasn’t something I recognised during my own treatment,” Zibners says. “I was doing what I was told because I was trying to get pregnant.” The shift came in 2021, when NICE recommended that all women at risk of miscarriage should receive up to 80 days of vaginal progesterone. At the time, no product had marketing authorisation that matched the guidance.

A conversation with her co-founder, Thang Vo-Ta – who pointed out their parent company’s relevant drug-delivery patents – opened a door. “We’d never discussed my seven rounds of IVF. When I described the injections – how thick progesterone-in-oil is, what it felt like to brace myself and push that needle in – I realised this was the only part of IVF I was still a little traumatised by.” That contrast revealed an uncomfortable truth: many women are still undergoing injections that most of the world abandoned long ago.

And leakage – you’ve described it as a practical problem, but also an emotional one.

She nods. “It causes enormous anxiety. You’re told to lie down for 30 to 60 minutes twice a day. Some women do more. Some rearrange their entire lives.” For patients with a history of miscarriage, every sign of discharge can trigger panic, she explains. Yet, many physicians underestimate this. “I’ve heard doctors say, ‘Just give them a pamphlet.’ A leaflet doesn’t change the fact that you’re watching medication come out of you and wondering whether any of it stayed in.”

“Just the economic implications in the UK of asking women to lie down for two hours a day, and then asking nurses and front desk staff at the fertility clinic to field the phone calls from women who are anxious,” says Zibners. “That is £236 million per annum.”

Design shaped by the lived experience

 

You’ve said that patient stories, including your own, shaped the product design. How did that influence the choices you made?

“Women who are trying to get pregnant will do anything and say thank you,” says Zibners. “Or they’ll simply drop out because they can't handle it. There’s no conversation. My doctor didn’t tell me anything – just that there’d be different needles in the bag.” The silence surrounding the harder parts of fertility treatment creates a landscape where discomfort is treated as inevitable, even invisible.

Calla Lily’s approach is different. “We’re not claiming better outcomes than existing vaginal progesterone – that would require enormous trials. What we’re offering is a better experience.” The team has put significant effort into packaging, instructions, and language, ensuring cultural sensitivity while keeping the device intuitive to use. “We want women to feel like someone has paid attention to their journey and their fear.”

The broader industry implications are clear: better experience means better adherence. Yet, vaginal treatments lag far behind other delivery routes in terms of design investment. Zibners often uses a memorable comparison when pitching to investors. “I’ll ask, ‘How many of you have put a drug up your nose?’ If nasal sprays leaked the way vaginal drugs do, someone would have solved that problem decades ago.”

You use an interesting method of testing the device. Can you tell us about that?

“The Syngina! It’s actually an industry standard for tampon manufacturers. You put a condom between the two ends of a glass beaker, and you pump warm water into it at the right pressure to create a made-up vaginal environment,” she explains. “Everybody who makes a tampon has to have this, but anyone else who's working on vaginal therapeutics can do it in reverse.

“We can actually measure how much drug we're releasing and how much leakage is still there that we didn't absorb. In order to de-risk everything we're doing, we've spent a lot of time trying to figure out exactly how to incorporate it, because we'll change the scaffold for every different drug. We'll run that through the Syngina so that we can make sure we've de-risked before we go to any sort of in-human trial.”

A question of access and equity

 

Fertility treatments demand time, privacy, and flexibility – things not everyone has. How do those realities shape the need for alternative delivery methods?

“Fertility is deeply unpredictable,” Zibners says. Appointments can change overnight. Procedures depend on hormone levels. Women who work in rigid environments – hospitals, retail, shift-based jobs – can find the logistics almost impossible.

“I had the luxury of flexibility during treatment,” she acknowledges. “If I’d been working as an attending in A&E, there’s no way I could’ve managed it.” Add on childcare responsibilities, transport costs, and recovery periods, and the barriers stack up quickly.

While Calla Lily cannot remove all the unpredictability inherent to IVF, Zibners believes they can remove the expectation that women must lie still for hours each day. “Infertile women are driven. If you tell her to lie down for an hour, she’ll lie down for two. But that isn’t feasible for someone who has to get kids out the door or work a full shift. The goal is to let women get on with their lives without compromising their treatment.”

Beyond fertility

 

Fertility is your first indication. Where else do you see this technology making an impact?

“Progesterone touches almost every stage of reproductive life,” she explains. It is used in early pregnancy, miscarriage prevention, and preterm birth – all areas where leakage remains a problem. But the reach goes further.

Menopause is another major area. “Many women can’t tolerate oral progesterone. If they’re on oestrogen and have a uterus, they need progesterone to protect the lining. The British Menopause Society now suggests that women on GLP-1s may need supplemental progesterone – ideally vaginally – and that is extremely leaky.”

Then comes the vaginal microbiome. “People assume recurrent UTIs and bacterial vaginosis are solved. They are absolutely not solved.” Delivering live bacteria vaginally is notoriously difficult; Calla Lily believes its device can protect and release these organisms more effectively, potentially unlocking new treatment avenues.

Further ahead are cervical cancer therapies, targeted endometriosis drugs, and other molecules that benefit from local delivery. “We’re a small company,” she says, “but the platform has applications across much of gynaecology.”

With so much need, what stands in the way?

She doesn’t hesitate. “Funding. And then funding.”

“Our funding needs are obviously bigger, and the challenge of finding people who are willing to invest in a space that they may not understand the need for. Just being in the drug device area, there are people who invest in devices, but not drugs. There are people who do drugs, but not devices. There are very few people who do both.”

Another issue, she notes, is that women’s health remains clouded by wellness products that lack regulatory rigour and make it harder for serious science to stand out.

Then, there’s also a cultural headwind. “We cannot get Google Ads because we’re a vaginal drug delivery platform,” she says. “Men can advertise almost anything. Women’s health products get blocked because of a single word.” A steady stream of ED advertising contrasts sharply with the restrictions placed on treatments for conditions affecting every woman.

The irony, she adds, is that she found a workaround by writing so extensively about vaginal drug delivery on LinkedIn that Calla Lily now appears organically in search results. “Not the original plan,” she admits, “but it works.”

The discomfort extends beyond algorithms. Some investors, she notes, still need to “ask their wives” whether a product like this is needed. “I always want to say, ‘Is your wife an investment professional?’ But if someone has personally experienced fertility challenges, they understand immediately.”

The long-standing taboo around reproductive health is something she navigates strategically. “We don’t go for shock factor – no vaginal jewellery, no cupcakes shaped like anatomy. If I can’t sit next to my dad while showing our pitch deck, it’s probably not the right direction. You can push people so far they shut down.”

Looking ahead

 

And how have people – patients, clinicians, investors – reacted to what you’re building?

Most reactions fall into one of two categories: relief or astonishment. Relief from women who’ve experienced injections, leakage, or both. And astonishment from those who assumed someone had solved this already.

“The patient response has been, ‘Wow, yes, this would be much better.’ Also, people have said, ‘Oh, genius. How come nobody thought of that?’ It seems such a straightforward thing to do. Most Americans, when they find out that the rest of the world is not using progesterone and oil routinely, they get a little angry.”

“We want to have women go about their lives, do their jobs, take care of their kids, go out with their friends, do whatever, go to exercise class, go do it knowing you're getting the right dosage without any other concerns,” she says.

What does success look like over the next few years?

“I would love to see our product in patients’ hands,” she says. “That's not going to happen through us. That's going to happen through strategic licensing agreements with bigger pharmaceutical companies. We don't have those logistics, but I would like to know that that's gone into somebody's hand for at least one indication.”

Her ambitions stretch into global health. “There’s evidence vaginal progesterone could help prevent conditions like preeclampsia. Imagine being able to deliver this affordably in low-resource settings. Half a million babies die from complications related to prematurity each year. Wouldn't it be great if we could have a successful product in the fertility market that could take advantage of the profits there and turn around and do something else in other areas, where we're addressing real public health concerns? That’s the dream.”

Dr Lara Zibners

About the interviewee

Dr Lara Zibners holds an MD with honours from The Ohio State University College of Medicine, an MMEd from the University of Dundee, and an MBA from the UNC Kenan-Flagler School of Business. She is the national educator for trauma training at the Royal College of Surgeons, England. She is also a published author and has appeared on television and media such as Rachael Ray and in print media, including Parenting & Forbes magazine.

Zibners co-founded Calla Lily Clinical Care based on her experience from multiple failed IVF cycles, which involved hundreds of painful intramuscular injections, as well as leaky pessaries and suppositories. With a broad background in clinical medicine and medical education in both the US and UK, she brings a unique understanding to Calla Lily of the scientific, systematic, and business challenges facing women’s healthcare.

About the author

Eloise McLennan is the editor for pharmaphorum’s Deep Dive magazine. She has been a journalist and editor in the healthcare field for more than five years and has worked at several leading publications in the UK.

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