Dienogest is well tolerated and alleviates endometriosis related pain

Dienogest is highly effective and well tolerated in relieving chronic, debilitating pelvic pain of endometriosis including menstrual pain and dysparunia says results of a 12-month single-center clinical trial published ahead of print in Journal of Obstetrics and Gynecology.  This is the first new medical treatment for endometriosis related pain since a decade.

Dienogest is a synthetic oral progestogen and has recently been introduced as a new medical treatment for endometriosis in more than a decade. It is highly selective for progesterone receptor and displays strong progestational effects and moderate antigonadotrophic effects, but no androgenic, glucocorticoid or mineralocorticoid activity.

It also can be taken orally and have a long half-life for once daily administration.

Endometriosis affects 5 - 10 per cent of women of reproductive age and impacts a woman's social, professional and personal life.

This is an observational, single center trial that enrolled 132 women with a surgically confirmed diagnosis of endometriosis for more than 2 years or a clinical diagnosis of disease with endometriosis-associated pelvic pain score of at least 40 mm on a 100-mm visual analog scale (VAS).

The women were on Dienogest 2 mg daily at the time of entering into study for no more than 30 days.

Women were routinely assessed for pelvic pain at 1 (V1), 3 (V2), and 12 (V3) months of follow up.

The women reported considerable relief in pelvic pain: from an 8.9 baseline VAS to 2.4 at end of 1month treatment [V1], 1.1 at 3 months treatment [V2], and 0.8 at 12 months treatment [V3]).

Significant relief was also observed in dyspareunia, from a baseline score of 6.7 to 2.8, 1.4 and 1.4 at the end of 1,3 and 12 months respectively.

Patients also were relieved of dyschezia, from a baseline score of 5.7 to 1.2, 0.5 and 0.5 respectively at the predefined interval.

Most frequently reported side effects were changes in menstrual bleeding patterns, breast tenderness, weight gain, loss of interest in sex and vaginal dryness. But, only 21 patients discontinued the treatment because of side effects.  

In other similar clinical trials, it fared well and was not found inferior to depot leuprorelin in reducing pelvic pain and was not significantly different from intranasal buserelin and depot triptorelin in improving combined symptoms/signs scores or revised American Fertility Society (rAFS) staging scores, respectively.

Therefore , the researchers concluded, that oral dienogest offers an effective, generally well tolerated therapeutic option for the long-term treatment of endometriosis.