Semaine: building an evidence base in women’s health
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Semaine: building an evidence base in women’s health

By Kezia Parkins 16 Aug 2021 (Last Updated November 2nd, 2021 07:16)

Natural health firm Semaine discusses its new approach to period pain and what it’s like to run trials as a family start-up.  

Semaine: building an evidence base in women’s health
Wanting to bridge the gap between wellness and pharma and foster trust in the women’s health supplement space, Semaine is determined to conduct clinical trials for its period pain products. Semaine founders from left to right: Matt Crane, Lauren Lee-Crane, Catherine Lee. Image credit: Semaine Health

After years of witnessing his wife Lauren Lee-Crane and her twin sister Catherine Lee suffering at the hands of endometriosis and chronic period pain, bioengineer Matt Crane started a quest for a solution.

After finding a concoction of natural ingredients that wiped out the sisters’ pain, the trio started Semaine Health, a natural supplement startup that aims to reduce difficult symptoms of menstruation in a space where there are few options other than painkillers available. Aside from merely masking pain rather than tackling the cause of it, overuse of painkillers can cause irreparable damage to the body, as the sisters know.

Wanting to be taken seriously by the medical community and provide people suffering from painful periods with a product grounded in evidence-based research, the family decided to run their own clinical trials.

Clinical Trials Arena sat down with Semaine Health co-founders Lauren Lee-Crane and Matt Crane to find out more about their journey into clinical research as a small family-run start-up, the challenges they faced and how they are hoping to kickstart more investigations into this long-neglected area of women’s health.

Kezia Parkins: Tell us a bit about your journey to finding a solution for chronic period pain.

Lauren Lee-Crane: I’ve had painful periods since I was 14 and the same with my twin sister Catherine, our co-founder. They got worse into our later 20s and eventually we were both diagnosed with endometriosis.

I was taking ibuprofen with codeine – anything that would help mitigate the pain and I essentially ruined my stomach lining by taking so much medication. With the pain continuing Matt, who has been on this journey with me, decided to try and figure out something to help with the pain that wasn’t going to hurt my stomach. Matt did hundreds of hours of reading up on clinical research that had been done on plant extracts specifically for either endometriosis or dysmenorrhea [pain associated with menstruation].

He started mixing lots of different anti-inflammatory ingredients together, like curcumin, green tea, resveratrol and magnesium and put them into my morning smoothies. I had a pain-free period, which I didn’t think was ever possible for me. We were in Seattle at the time with Matt working at the University of Washington’s Medical Center. We decided to quit our jobs and start seriously working on the product.

We had the pills manufactured and launched Semaine in March 2020.

KP: With Semaine, has it been tough to be taken seriously by the wider medical profession and investors?

Matt Crane: With my biomedical background at first it took a little bit of changing my brain when thinking about the wellness space and plant extracts and embracing that. But the more we got into it, the more we realised that there is a reason that wellness is really popular among women – because there aren’t often solutions being addressed empathetically in the pharma space.

This is why there’s so much interest from women in diverse communities in the wellness space and alternative practices because that’s where they have to go and find solutions and people to take them seriously.

That’s why for Semaine, we really wanted to be grounded in science and do clinical trials and really take what we’re developing very seriously to show healthcare professionals, pharma and everybody else that this is a good product that does make a difference.

The clinical trial data we will have in the future will include blood biomarkers to show that Semaine is really affecting what we suspected – reducing inflammatory pathways.

At the same time, we still want to be grounded in the wellness space, because that’s where women are typically going to find these solutions because they’re not finding them in the pharmacy aisles or with physicians.

We have gotten some pushback from ob-gyns or physicians because there’s an understandable concern that sometimes, especially in the natural product or supplement space, people can play on hopes and there might not be evidence backed up. Especially in the endo space, when we were looking for solutions for Lauren, initially, there’d be a lot of people marketing things for hundreds of dollars because they know people are desperate for an answer.

So, I think physicians are often very reluctant, but that is what we want to help change and why we’re doing clinical trials. We want to bridge that gap between the two – the place where women are finding the care they want, which tends to be the wellness space because it’s empathetic women-focused communities, and the old-school of academic pharma and medicine, which is slowly changing.

KP: How does bringing a natural supplement to market differ from bringing a pharmaceutical product to market?

MC: In the US specifically, there was a bill passed in 1994 that separates natural products or natural extracts from plants from pharmaceutical products that have to have clinical trials to actually get approved by the FDA to treat certain conditions.

With plant extracts the regulation is largely around what you can talk about and claim the product can do but you don’t have to really do any trials to put them on the market. I honestly think it’s a big shame that there is such a gap between the two because by running a trial you get more evidence to show that stuff works.

It’d be nice if there was some kind of middle point in between the extremes for pharma regulation to treat diseases, and this natural product and supplements space because almost no one ever runs clinical trials on natural supplements even though there is a large body of literature that supports their uses in different ways.

KP: Can you tell us a bit about the first trial you have already run for Semaine?

MC: I would consider it more a consumer response trial just because it didn’t quite meet the bar for clinical trials. We didn’t register it on clinical trials.gov and it wasn’t an independent recruitment process. We recruited 24 women with self-reported period pain or discomfort – anything from bloating, or mood swings or really bad cramps. And then we did an open-label crossover with the goal being to establish a baseline level of discomfort after the first period and then get participants to fill out an online survey. Then we sent them the product to take the week of their period, and they filled out the survey again.

It was great because we got really good responses – significantly reduced bloating, cramps, pelvic pain and headaches.

We are conducting a second, larger trial where the patient recruitment and management is being handled by a third party. We are getting IRB approval and it’ll be registered on clinicaltrials.gov with the goal of making all the findings and details public. We also plan to publish the findings in an open-access peer-reviewed journal.

KP: Semaine focuses on reducing inflammation around the menstrual cycle, why so and how will you try to prove this in your next trial?

MC: Only in recent years have studies shown that higher inflammation polls are linked to not only worse cramping and bloating but also to mood changes, which both makes sense because the molecules that are inflammatory causing affect the brain but also general malaise in the body.

What we really wanted to do was show that Semaine helps lower the inflammatory state during the menstrual cycle.

To track inflammation in our upcoming trial and whether Semaine reduces it, we will be conducting blood draws. It’s important to time them precisely because we want to make sure that for both baseline menstrual cycle without the product, and the intervention cycle, where they’re actually taking the supplement that the blood draws are at the same point in the cycle.

For this reason, we’re limiting participation to people who are on birth control so that we can do the timing relative to when they start taking the pill.

The trial will be fully decentralised so participants will use at-home finger-prick blood tests and will send them off to a lab to be tested.

KP: As a small family run start-up what were the challenges in conducting clinical trials? Do you think having to time the trial around the menstrual cycle will make it more difficult?

LL-C: We’ve sent somebody to the moon, we’ve mapped the human genome, we can figure out how women’s hormones work and make sure that they’re not this complex, mysterious thing that is just not researched. As a woman going through the healthcare system, the only time you’re given any slightly in-depth information is if you’re interested in getting pregnant, and then it becomes a conversation about fertility but you’re not told about inflammation levels and how it corresponds to your cycle and how that can change your mood and pain levels.

MC: Conducting trials is tricky but my background in basic biology research gave me an understanding of statistics, experimental design and outcomes. It was a challenge to find a third-party organisation that would work with us within our budget to do patient recruitment.

Then finding an IRB and filling out the 20-page document to map out how the trial would be run and to get that approved is also challenging and takes a lot of time. There are also a lot of other moving pieces like registering on clinicaltrials.gov.

KP: What are your plans for the future of Semaine?

MC: Between 20% and 25% of women with period pain just don’t benefit from taking non-steroidal anti-inflammatories like ibuprofen and there isn’t a lot of research into why. Ibuprofen really just affects a single inflammatory pathway but there are other pathways that cause inflammation. I would eventually love to test whether our product, which uses plant extracts that target multiple pathways, helps that percentage of people that ibuprofen doesn’t.

I think there is a switching standard in wellness and people want to know that the supplements they are taking are good and effective and we would like to be at the vanguard of that movement by conducting clinical trials.

Why are we as a supplement brand running these trials when pharma is not? Maybe if we keep doing this we will be able to wake those people up.

We plan to expand our approach to clinical trials and product design and work on a pipeline of other products for ignored women’s health conditions like premenstrual dysphoric disorder and polycystic ovary syndrome.