Long-term use of the synthetic hormone dienogest proved effective in treating endometriosis-related pain and reducing the size of the ovarian cysts known as endometrioma that recur, a Korean study shows.
The research, “Efficacy and safety of dienogest in patients with endometriosis: A single-center observational study over 12 months,” was published in the journal Clinical and Experimental Reproductive Medicine.
Dienogest is a synthetic progestogen therapy whose effects are similar to the hormone progesterone.
In a previous double-blind placebo-controlled trial, researchers used dienogest to treat endometriosis-associated pelvic pain. When compared with placebo controls, those on 12 weeks of dienogest had less pain, with tolerable adverse effects.
A randomized, multicenter, open-label trial showed that 24 weeks of dienogest was as effective as leuprolide acetate (LA) in relieving endometriosis-related pain. LA is a standard medication for treating the disease.
In addition, there was no reduction in bone mineral density with dienogest, and it did not trigger hot flush, researchers found.
The evidence suggests that dienogest has more advantages then LA, and can be administered longer.
Researchers evaluated the safety and effectiveness of 2 mg of dienogest administered once a day at one center for at least 12 months to 188 Korean women with endometriosis.
They looked at changes in endometriosis-associated pain, the size of endometrioma, the recurrence rate, and adverse events from dienogest. In cases where dienogest was administered more than 18 months, the team also analyzed patients’ bone mineral density.
The analysis showed a significant reduction in endometriosis-associated pain 12 months after the start of dienogest therapy. In women with recurrent endometrioma, 12- and 18-month measurements indicated that dienogest led to a significant decrease in endometrioma size.
Blood in the urine was the most common adverse effect in the dienogest patients, but it affected only 3.2%. In general, other adverse events were tolerable.
The results suggest that long-term treatment with dienogest is safe and can be tolerated, and significantly reduced endometriosis-associated pain and the size of recurrent endometrioma.
Twenty percent of women treated with dienogest for 18 months or longer showed lower bone mineral density (BMD) than expected for their age.
“Therefore, it appears necessary to check BMD in women who take dienogest over the long term,” the researchers concluded.