DENVER – Daily self-administered vaginal danazol effectively decreased pain symptoms caused by rectovaginal endometriosis that persisted despite insertion of a levonorgestrel-releasing IUD, a small, prospective, self-controlled pilot study has shown.
The levonorgestrel-releasing IUD (Mirena) is indicated as a contraceptive, and also to treat heavy periods in women who choose to have an IUD. However, the device is also seeing expanding off-label use as a treatment for endometriosis. Several studies indicate the hormone-releasing IUD is effective at improving endometriosis-related pain symptoms in many women who don’t want to resort to oral or injectable medications (Contraception 2010; 81:117-22). But for the one-quarter to one-third of patients who request device removal after 6 months because of inadequate pain relief, what’s the next option?
That was the question Dr. Simone Ferrero and his colleagues set out to answer in a study he presented at the annual meeting of the American Society for Reproductive Medicine.
He reported on 15 women with rectovaginal endometriosis and chronic pelvic pain, deep dyspareunia, dysmenorrhea, and difficulty in defecating who remained symptomatic despite insertion of Mirena. At the time of study enrollment, they had been on the levonorgestrel-releasing IUD for a mean of 8.2 months and indicated they were either "dissatisfied" or "very dissatisfied" with it. They were then placed on vaginal danazol (Danocrine) at 100 mg/day.
After 3 months of dual therapy, patients reported a significant progressive decrease in mean pain scores on a visual analog scale for chronic pelvic pain, dysmenorrhea, and dyspareunia compared with baseline, as well as a nonsignificant trend for less intense dyschezia, according to Dr. Ferrero of San Martino Hospital and the University of Genoa (Italy).
After 6 months, the intensity of all of these symptoms was further diminished, and the reduction in difficulty in defecation had achieved significance. The volume of rectovaginal nodules was significantly reduced compared with baseline.
The most common treatment-related adverse events were dermatologic: seborrhea, acne, and/or oily hair in four patients, headache in three, weight gain in excess of 3 kg in two women, and vaginal irritation in two. No adverse effects were noted in lipid profiles, liver function, or clotting factors.
One patient didn’t complete the 6-month study, opting instead for endometriosis surgery at month 5. But 12 of the 15 subjects pronounced themselves satisfied with the dual therapy and opted to continue with it after completing the 6-month study.
The major remaining question unanswered by this or other studies is whether the improvement in pain symptoms will continue for the entire 5-year life of the coil, he noted.
Dr. Ferrero said he had no relevant financial conflicts of interest.