Endometriosis is an estrogen dependent, chronic inflammatory disease characterized by the growth of endometrial lining outside of the uterus. 1
Endometriosis affects roughly 10% (190 million) of reproductive age women and girls globally 2
1- Estrogen mediates inflammatory role of mast cells in endometriosis pathophysiology, McCallion A. et Al, 2022 Front. Immunol.
2- Zondervan KT, Becker CM, Missmer SA. 2020 N Engl J Med
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Pelvic Pain:
Dienogest 2 mg showed an improvement of the VAS (visual analog score) score at the 3rd month (p<0.001) that became even more evident from the 6th to 24th month follow-ups (p<0.001) 1
Quality of Life (QoL):
At the 3rd month follow-up, women reported QoL improvement (p<0.01). From the 6th to the 24th month follow-ups, women reported improvement in all categories compared the baseline scores (p<0.001) 1
1 – Effects of long-term treatment with DIENOGEST on the quality of life and sexual function of women affected by endometriosis-associated pelvic painCaruso, S., Iraci, M., Cianci, S., Vitale, S. G., Fava, V., & Cianci, A , Journal of Pain Research 2019, 12, 2371-2378
All eight guidelines recommend Dienogest as first-line medical treatment for pain in endometriosis
About Dienosis (Dienogest Tablets 2mg )
Each tablet contains 2 mg Dienogest
Therapeutic indication:
Treatment of endometriosis
Mode of Action (MoA)
Dienogest acts on endometriosis by reducing the endogenous production of oestradiol and thereby suppresses the trophic effects of estradiol on both the eutopic and ectopic endometrium.
SAFETY
In a pooled analysis of four clinical trials, DIENOGEST 2 mg was tolerated, with a favorable safety profile extending for up to 65 weeks 1
Most commonly AE in <10% of patients: 2
-Headache
-Breast discomfort
-Depressed mood
-Acne
In a real life study, with more than 3000 patients treated with Dienogest 2 mg daily, the most frequently reported ADR were:
-Abnormal uterine bleeding 4.14% (129/3113)
-Increased weight 2.57% (80/3113)
-Headache 1.22% (38/3113).
The number of patients with favorable bleeding patterns was observed to increase as the duration of treatment increases.
Amenorrhea was observed in 46.26%, and 53.20% of patients at 12 months, and more than 12 months follow-up period: 3
1- Strowitzki T, Faustmann T, Gerlinger C, et al. Safety and tolerability of dienogest in endometriosis: pooled analysis from the European clinical study program. Int J Women’s Health. 2015;7:393–401
2- Naari SmPC, “Dienosis” ( Dienogest 2mg), 2021
3- Baikseol.Cho et al Safety and Effectiveness of Dienogest (Visanne®) for Treatment of Endometriosis: A Large Prospective Cohort Study. Reproductive Sciences volume 27, pages905–915 (2020)