Contemporary OB/GYN week in review: Sildenafil Cream, fezolinetant, and more

Thank you for visiting the Contemporary OB/GYN® website. Take a look at some of our top stories from last week (Monday, August 26 - Friday, August 30, 2024), and click each link to read and watch anything you may have missed.

Phase 2b safety data for Sildenafil Cream against FSAD reported

Safety and tolerability data for Sildenafil Cream, 3.6% as on-demand treatment of female sexual arousal disorder (FSAD) from the phase 2b RESPOND clinical study has been published in The Journal of Sexual Medicine, according to Daré Bioscience, Inc.

In the RESPOND study, the systemic and local genital safety of Sildenafil Cream was evaluated across 12 weeks in healthy premenopausal women with FSAD and their sexual partners. Sildenafil Cream was evaluated in 1357 sexual encounters and compared to placebo in 1160 sexual encounters.

Participants reported treatment emergent adverse events (TEAEs) and sexual events in an eDiary, which was reviewed at each monthly follow-up visit. There were no significant differences reported in the prevalence of TEAEs among participants receiving Sildenafil Cream vs placebo, with mean times of onset of the first TEAE of 21 ± 11 days and 20 ± 8 days, respectively.

Click here for the full article.

First patient dosed in trial evaluating fezolinetant for VMS in breast cancer patients

The first patient has received dosing in the phase 3 HIGHLIGHT 1 clinical trial evaluating the use of fezolinetant (VEOZAH; Astellas Pharma Inc) to treat moderate to severe vasomotor symptoms (VMS) in breast cancer patients with adjuvant endocrine therapy.

The safety and efficacy of fezolinetant are being evaluated in HIGHLIGHT 1, a randomized, placebo-controlled, double-blind trial. Participant include women receiving adjuvant endocrine therapies to treat stage 0 to stage 3 breast cancer experiencing moderate to severe VMS.

There are 540 participants planned for inclusion in the analysis, randomized 1:1 to receive fezolinetant or placebo across up to 100 sites worldwide. The change in moderate to severe VMS frequency and severity from baseline to weeks 4 and 12 are the coprimary endpoints of the analysis, with a final evaluation following 52 weeks of treatment at 55 weeks.

Click here for the full article.

Reducing geriatric breast cancer screening through cessation messaging

Support for and intentions of breast cancer screening cessation are increased among older women through a breast cancer screening cessation message, according to a recent study published in JAMA Network Open.

Women aged 65 to 75 years were included in the analysis and randomized into groups receiving a different number of messages over 2 points. Additional differences between groups included the source of the messages and the message content.

There were 4 groups created. Group 1 never received the screening cessation message, while group 2 only received it during wave 1 from a clinician, group 3 received it wave 1 from a news story and wave 2 from a clinician, and group 4 received it wave 1 from a family member and wave 2 from a clinician.

Support for screening cessation at wave 1 was lowest in group 1, with a mean score of 2.66 on the 7-point scale. When a screening cessation message was delivered by a clinician, this score significantly rose to 3.52, vs 3.58 for a news story and 2.94 for a family member.

Group 1 also had the lowest score for supporting screening cessation at wave 2, with a mean score of 2.68. In groups 2, 3, and 4, these scores were 3.14, 4.23, and 4.12, respectively. This indicated a 17.8% increase in participants supporting screening cessation of the hypothetical patient in group 1 vs a 47% increase in group 3.

Click here for the full article.

Link found between fish oil intervention, genotype, and offspring AD risk

The maternal cyclooxygenase-1 (COX1) genotype impacts the association between ω-3 long-chain polyunsaturated fatty acid (n-3 LCPUFA) supplementation and childhood atopic dermatitis (AD) risk, according to a recent study published in JAMA Dermatology.

Thromboxane A2 (TXA2) pathway eicosanoids were reduced in patients with n-3 LCPUFA supplementation during pregnancy. Additionally, significant reductions in 11-dehydro-TXB2 and 11-dehydro-2,3-dinor-TXB2 were reported after the n-3 LCPUFA intervention.

There were also associations between single-nucleotide variations (SNVs) involved in the COX1 enzyme and TXA2 eicosanoid levels. This included the COX1 rs1330344 SNV and minor allele (C). Similar findings were reported for 2 individual TXA2 eicosanoids.

Click here for the full article.

HIV Roundtable: Examining aging with HIV, multidrug resistance, and vaccine development

In this episode, the panel provides clinical feedback on HIV and aging, multidrug resistant HIV, and vaccines. Castilho says for those patients who are older and who have managed HIV as a chronic condition for years can often be at a higher risk of aging comorbidities. “We've already heard that HIV treatment has become a lot easier, but the health concerns of older adults living with HIV are increasingly complex, not necessarily because of management of their HIV, but because of the excess and often earlier onset of these comorbidities that many people with HIV experience,” Castilho said. “They are at higher risk for conditions like high blood pressure or diabetes, heart disease, certain cancers and other conditions which really affect their daily quality of life and physical function. So, many times the health concerns that we're encountering and patients are managing on a daily basis are not HIV, but are these chronic comorbidities, and their subsequent conditions like polypharmacy or needing to navigate taking multiple medications.”

With regards to an HIV vaccine, the clinicians acknowledge the complexity of developing a vaccine for the virus, but acknowledge another virus that was helped in the process. “Using COVID as an analogy is helpful because we all experienced viral evolution and understanding how certain parts of a virus can change over time that we needed different vaccines to manage the COVID pandemic and HIV…so it makes it inordinately challenging to find a vaccine,” Ahonkhai said. “The virus itself is very smart and very tricky, and makes this challenging. A lot of mRNA research that led to the COVID vaccine being developed had come out of the HIV field. So, we have HIV to thank even though we don't have a vaccine for HIV just yet…but I think we're all hopeful that we can get there.”

Watch here.