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.
