Viagra, the blockbuster drug that has been used to treat erectile dysfunction (ED) since 1998, may eventually be used to treat painful menstrual cramps, according to research reported in the journal Human Reproduction.
Though the study in the report was small, including only 25 women suffering from moderate to severe menstrual cramps, the results were encouraging enough that further research was recommended, and could eventually result in a new treatment option for the painful cramps, which are suffered by an estimated 85% or more of young adult women. Menstrual cramps occur when the uterus contracts, pressing against nearby blood vessels and temporarily shutting down oxygen supply to uterine muscular tissue. The pain from cramping occurs when part of the muscle briefly loses its supply of oxygen, according to the Cleveland Clinic.
Previous Studies on Sildenafil and Menstrual Cramps
Sildenafil is the active ingredient in the drug Viagra, and it works by enhancing the relaxing effects of nitrous oxide on myometrial cells, which are the smooth muscle cells in the uterus. While it can alleviate pain when taken orally, the incidence of side effects like headaches is too high to make the drug practical for routine use when taken orally. Sildenafil, which is in a class of drugs called PDE-5 inhibitors, causes the uterine tissue to remain relaxed so that blood flow is less likely to be restricted due to uterine contractions. The recent study, which took place in Croatia in conjunction with researchers from Penn State, used sildenafil in a vaginal formulation.
Design of the Study
The recent study was double-blind, randomized, and controlled, and it compared a vaginal preparation of 100 mg sildenafil citrate to placebo during the occurrence of painful menstrual cramps. Pain relief was measured using the TOPAR4 scoring system, where higher scores represented more significant pain relief. Compared to placebo, the sildenafil resulted in better pain relief over four consecutive hours.
Participants were women in general good health, aged 18 to 35, and who suffered from moderate to severe primary dysmenorrhea (uterine cramps that are the result of menstruation, not the result of some other disorder). Baseline assessments of pain were taken, as were assessments of pain at 1, 2, 3, and 4 hours after treatment.
Using the TORPAR4 score, the group of women receiving sildenafil had significantly better pain relief compared to the women who took a placebo. However, because the researchers lost funding (provided through National Institutes of Health grants) and could not use a larger sample size, larger studies in multiple locations, and of longer duration are deemed necessary to confirm the findings of this study. What researchers hope is that further studies will indicate that vaginal sildenafil will provide a safe and effective treatment option for women with cramps, particularly for those who do not respond well to current treatments, which primarily include non-steroidal anti-inflammatory (NSAID) drugs like ibuprofen.
How Researchers Believe Sildenafil Works on Menstrual Cramps
This was the first test of the effects of sildenafil given vaginally on menstrual cramps. Dr. Richard Legro of the Penn State College of Medicine, who worked with the Croatian researchers, said that the vagina is a promising route for drug administration in this case, because delivering the medication closer to the target organ decreases the incidence of side effects, which were problematic in studies in which sildenafil was given orally. The researchers hypothesize that when blood vessels around the uterus are dilated, increased blood flow may flush out substances called prostaglandins, which signal the uterus to contract.
The research team has already submitted grant applications for study of the difference between oral and vaginal use of sildenafil in treating menstrual cramps, as well as study of dosing over multiple menstrual cycles. Sildenafil, the active ingredient in Viagra, was discovered by accident to improve erections during studies in the 1990s on men suffering from heart conditions. Since the drug’s approval for treating ED, it has also shown promise in treating a range of other health conditions, ranging from pulmonary hypertension to altitude sickness.
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