Historically, women and people who menstruate have been underrepresented when it comes to clinical research. For example, there has been little investment in clinical trials looking into new and existing forms of birth control, something used by millions of women every day despite numerous unpleasant side effects.
There is also a huge need for more clinical trials of both existing and investigational drugs in pregnant people – the current Covid-19 vaccines have only just started conducting trials in this group. There are also numerous illnesses that only affect women and people who menstruate that are largely overlooked by the healthcare industry, with no cure and few treatment options available.
Clinical Trials Arena highlights five new trials set to begin in neglected areas of women’s health.
Testing Covid-19 vaccines in pregnant people
Throughout the pandemic, pregnant people have received mixed-messaging around whether it is safe for them to get a Covid-19 vaccine, as none have been clinically tested in this group.
MOMI-VAX is a study sponsored and funded by the US National Institute of Allergy and Infectious Diseases (NIAID) and being conducted by the Infectious Diseases Clinical Research Consortium (IDCRC). The trial is set to evaluate the immune responses generated by Covid-19 vaccines administered to pregnant or postpartum people.
Researchers will measure the development and durability of antibodies against Covid-19, in people vaccinated during pregnancy or the first two months after delivery. They will also assess vaccine safety and evaluate the transfer of vaccine-induced antibodies to infants across the placenta and through breast milk.
Up to 750 pregnant individuals and 250 postpartum individuals within two months of delivery who have received or will receive a US Food and Drug Administration (FDA) approved Covid-19 vaccine will be enrolled, as will their infants. Vaccines are not provided to participants as part of the study protocol.
There are currently three Covid-19 vaccines available in the US under Emergency Use Authorization (EUA) from Moderna, Pfizer-BioNTech and Johnson & Johnson.
The study is designed to assess up to five types of FDA-licensed or authorised Covid-19 vaccines, should additional options become available.
A new type of breast cancer MRI
Oxford-based Perspectum Diagnostics is testing a new and more comfortable way of detecting breast cancer, which could help identify tumours at an earlier stage and in younger women. Conventional MRI scans require patients to lay face down in a cold and noisy machine for up to 75 minutes, which can be very distressing.
Multiparametric MRI is a new technique now widely used across Europe and the US to evaluate liver diseases without the need for a painful biopsy.
Like traditional MRI, it uses strong magnetic fields and radio waves to stimulate protons in the tissue, using differences in the amount of time they take to settle to map the various tissues in the breast.
By combining images created by different MR pulses and sequences, multiparametric MRI allows for an even more detailed map to be generated.
Perspectum has secured ethical approval to recruit 1,030 women to the trial, including 10 with confirmed breast cancer and 30 to 40 healthy women who are currently being scanned, to test whether the technique can accurately map their breast tissue while they are lying on their back and far more comfortable, according to The Guardian.
The researchers expect that the trial will take about two years to complete.
Defining outcomes in endometriosis
Endometriosis is a condition where tissue similar to the lining of the womb starts to grow in other places, such as the ovaries and fallopian tubes. It is a chronic disease that affects one in 10 women and people with uteruses and causes severe abdominal pain during menstruation and throughout the menstrual cycle.
There is currently no cure for endometriosis and standard care is full of variation.
“One way of dealing with this unwanted variation is the shift towards a value-based endometriosis care,” says One Clinic which is currently recruiting a study to define a standard set of value-based patient-centred outcomes for endometriosis.
Different standardised data sets have already been developed to measure outcomes in many other pathologies, but have not yet been determined for endometriosis.
One Clinic describes value-based healthcare (VBHC) as “a strategy focused on the optimisation of the balance between outcomes that are important to patients and cost to achieve these outcomes.”
They are currently looking to enrol 60 participants to become part of a group of international experts comprised of patient experts, gynaecologists, radiologist, psychologists, nurses and researchers, “that have been identified based on their expertise in the field or due to their active role in an endometriosis patient association.”
The primary outcome measure is agreement on a list of Patient Reported Outcome Measures (PROMs) and Clinical Reported Outcome Measures (CROMs) that are relevant and feasible in endometriosis care. Agreement is defined as a consensus of 70% between expert panel members.
A new birth control pill
Oregon Health & Science University’s Women’s Health Research Unit is conducting a study to evaluate the safety and effectiveness of a new investigational birth control pill, LPRI-424, at preventing pregnancy.
LPRI-424 is a combined birth control pill that contains progestin and oestrogen, although at a lower dose of oestrogen than other birth control pills currently available.
Researchers expect that this will reduce the number and/or intensity of side effects.
LPRI-424 is designed as an extended-release tablet, meaning the active ingredients are released slowly and work for longer. This helps to reduce daily changes of hormone levels in the blood.
The study, which is in Phase III, aims to demonstrate the contraceptive efficacy of LPRI424, and the safety and tolerability of the drug.
This trial is a prospective, multicentre, open-label, non-controlled trial in female subjects between the ages of 15 and 45 who go to the clinic seeking contraception.
The trial will include people who menstruate who have never used hormonal contraceptives before consent, those who have used hormonal contraceptives in the past but have had a full menstrual cycle during the drug-free period and participants directly switching from another hormonal method.
Following confirmation of eligibility, participants will be given the pill and trained to use an electronic diary. Researchers are currently enrolling 995 participants.
Vitamin D for ovulation in people with PCOS
Polycystic ovary syndrome (PCOS) is a condition that affects female hormone levels. Symptoms include irregular periods, facial hair and difficulty getting pregnant.
The University of Hong Kong is testing the hypothesis that vitamin D supplementation leads to significant improvement in the ovulation rate of women with PCOS, either spontaneously or with an oral ovulation induction agent.
A group of 220 anovulatory women (those who don’t ovulate) with PCOS will be recruited.
Participants will be randomised to the vitamin D group or placebo group. Those in the vitamin D group will take vitamin D 50,000 IU a week for 4 weeks, followed by 50,000 IU once every two weeks for 52 weeks. Those in the placebo group will take placebo pills with the same external appearance.
Participants who remain anovulatory after six months will be treated with a six-month course of letrozole for ovulation induction.
The primary outcome of the trial is the ovulation rate which will be compared between the two groups.