For example, using a dose of dienogest 2 mg daily, the reduction of endometriosis-related pain was significant; however, in 95% of cases spotting was reported. A mouse model of endometriosis shows that dienogest reduces lesion size better than duphaston and Esmya, although all three were effective. Safety and tolerability of dienogest in endometriosis: pooled analysis from the European clinical study program Thomas Strowitzki,1 Thomas.

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Abstract Endometriosis is a chronic disease primarily affecting women of childbearing age, in which endometriotic lesions form outside the uterus, typically leading to painful symptoms, fatigue, and infertility. Dieenogest is a progestin investigated for the treatment of endometriosis.

Surgical intervention includes ablation of endometriotic lesions, enfometriosis of endometriotic cysts, and division of adhesions. Adverse events AEs were defined as any unfavorable and unintended sign, symptom, or disease occurring with the use of study medication.

Footnotes Disclosure The author declares that he has no conflict of interest in this work. More than just menstrual cramps: Editor who approved publication: The majority of women suffering from endometriosis are of reproductive age and so may require contraception. The clinical importance of dienogest. Following the intent-to-treat principle, all women who took study medication at least once were included in the current pooled analyses full analysis set.

Based on the available data, dienogest provides complete ovulation inhibition at a daily dose of 2 mg.


None of the treatment-related adverse events was rated as serious. The study discontinuation rates associated with dienogest 2 mg were broadly consistent across studies, including the long-term extension study and were similar to those reported for LA in the week active comparator-controlled study ie, 12 events in 5 [3.

Dienogest offers unique pharmacologic benefits relevant to the treatment of endometriosis, including potent progestogenic effects endmoetriosis lead to effective endometrial lesion reduction, combined with endomrtriosis moderate suppression of estrogen levels and no significant androgenic, mineralocorticoid, or glucocorticoid activity.

Duphaston also increased levels of cell death markers.

Dienogest in long-term treatment of endometriosis

Dienogest demonstrates a number of characteristics in preclinical studies that are relevant to its use in endometriosis. Oral contraceptives and risk of endometriosis: As with other progestins, there are limited data on the use of dienogest in pregnant women. Three-vs six-month GnRH-agonist therapy. Int J Womens Health. Results of the cytological smears were classified at each study site according to the local classification scheme. In comparison to progestins with androgenic activity such as medroxyprogesterone acetate and norethindrone acetate, 18 — 20 dienogest has a more favorable profile with low incidences of androgenic effects.

By contrast, headache was reported in Recent pharmacodynamic data in volunteers indicate that ovarian activity resumes rapidly range 1—43 days after cessation of dienogest. In addition, dienogest at both these doses improved patient-reported symptoms, including the intensity of dyspareunia, dysmenorrhea, and diffuse pelvic pain.

[Full text] Safety and tolerability of dienogest in endometriosis: pooled analysis | IJWH

As endometriosis is a chronic disease, consideration should be endometrioosis not only to the efficacy but also to the long-term safety and tolerability of the treatment options that are available. Arch Gynecol Obstet ; Dienogest in the treatment of endometriosis-associated dienobest pain: Mean heart rate and blood pressure were relatively stable over time in the pooled dienogest 2 mg group Table 4as they were in the comparator groups.


Boxplots were drawn using first and third quartiles as the bottom and top of the boxes, respectively; medians were indicated by horizontal lines.

The effectiveness of dienogest at the 2 mg daily dose was compared against placebo diengoest a week, randomized trial using a range of tools for measuring changes dienogesf symptoms and quality of life.

The 2 mg and 4 mg dienogest doses were generally well tolerated and rates of discontinuations due to adverse events were low. Mean visual analog scores decreased from There is no cure for endomftriosis management consists of alleviating pain and other symptoms, reducing endometriotic lesions, and improving quality of life.

Sex steroids used in hormonal treatment increase vascular procoagulant activity by inducing thrombin receptor PAR-1 expression: Participants Of women with confirmed endometriosis who were included in the four studies, were treated with dienogest 2 mg once daily for study periods between 12 weeks and 65 weeks.