Vaginal Sildenafil for Menstrual Pain

(SILDYS Trial)

This trial tests a new treatment for menstrual pain using a vaginal suppository of sildenafil citrate, a medicine often used for other conditions. The goal is to determine if it can reduce painful uterine contractions during menstruation and provide quick pain relief. Participants will receive both the actual treatment and a placebo (a dummy treatment) in different menstrual cycles to compare effects. Women with moderate-to-severe period pain and regular cycles may be eligible to join. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

You may need to stop taking certain medications, like nitrates, nitric oxide donors, and some other specific drugs. The trial doesn't mention all medications, so it's best to discuss your current medications with the study team.

Research has shown that sildenafil citrate in a vaginal form can ease sudden menstrual pain without known negative effects. Studies have found that women using this method experience better relief from menstrual cramps. No major side effects have been reported with this vaginal use of sildenafil, suggesting it is well-tolerated and considered safe based on previous research.¹²³⁴⁵

Unlike the standard treatments for menstrual pain, which often include NSAIDs like ibuprofen or hormonal therapies, the use of vaginal sildenafil is unique because it leverages a new delivery method and mechanism of action. Sildenafil, commonly known for treating erectile dysfunction, works by increasing blood flow. When delivered as a vaginal suppository, it targets the uterine area directly, potentially offering faster and more localized pain relief. Researchers are excited about this treatment because it could provide an alternative for those who find little relief from traditional painkillers or who experience adverse effects from systemic medications.

This trial will evaluate the effectiveness of vaginal sildenafil citrate in reducing menstrual pain. Studies have shown that vaginal sildenafil citrate can alleviate menstrual pain in women with moderate to severe painful periods. Research suggests it works by relaxing muscles and improving blood flow, easing the strong cramps of the uterus during menstruation. In earlier trials, patients using vaginal sildenafil reported less pain without major side effects. Although more research is needed, these findings suggest that this treatment could be a promising option for those dealing with painful periods.¹²³⁴⁵