Detailed analysis of a randomized, multicenter, comparative trial of dienogest versus leuprolide acetate in endometriosis

Abstract

The analyses provide supportive evidence that the efficacy of DNG is equivalent to that of LA for treating endometriosis symptoms, with specific quality-of-life benefits and a favorable safety profile.

Study of dienogest for dysmenorrhea and pelvic pain associated with endometriosis

“…DNG, which may be used for 1 year or more [1314], was used instead of a GnRH-a which has a limited duration of use, as it decreases bone mineral density. A comparative trial of DNG (2 mg/day) versus a GnRH-a [1516] concluded that DNG is as effective for the relief of pain associated with endometriosis [15]. The proportion of women free of pelvic pain and dysmenorrhea at 24 weeks was approximately 60% in both treatment arms: 82% in the DNG group and 90% in the GnRH-a group, respectively [16].…”

Reevaluating response and failure of medical treatment of endometriosis: a systematic review

“…of articlesPublication year(s)Total no. of patientsaTreatment duration, moStudy typeFunding sourcebDanazol31982–19984814 to ≥6Prospective cohort study (n = 2) 9, 10; retrospective study (n = 1) (11)Nonindustry (n = 3)Gestrinone319957026RCT (n = 3) 12, 13, 14Nonindustry (n = 3)Mifepristone120162706RCT (n = 1) (15)Nonindustry (n = 1)GnRH agonists141988–20002,7833–6RCT (n = 12) 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27; prospective cohort study (n = 2) 28, 29Industry (n = 8); partial industry (n = 3); nonindustry (n = 3)GnRH agonists plus add-back therapy41998–20167385–12RCT (n = 3) 30, 31, 32; prospective cohort study (n = 1) (33)Industry (n = 1); partial industry (n = 1); nonindustry (n = 2)Progestins142000–20162,6943–12RCT (n = 8) 34, 35, 36, 37, 38, 39, 40, 41; prospective cohort study (n = 5) 42, 43, 44, 45, 46; retrospective study (n = 1) (47)Industry (n = 7); partial industry (n = 2); nonindustry (n = 5)CHCs…”

Pelvic Pain and Quality of Life of Women With Endometriosis During Quadriphasic Estradiol Valerate/Dienogest Oral Contraceptive: A Patient-Preference Prospective 24-Week Pilot Study

“…[32][33][34] Dienogest has a strong endometrial affinity and it may directly decrease growth, neoangiogenesis, and proliferation of endometriotic lesions. [7][8][9][10][11][12][13][14] In our study, DNG was used at doses sufficient to perform this clinical effect. The cumulative exposure per cycle to DNG was about 2.2 mg/d, which is comparable to that approved for the treatment of endometriosis (2 mg/d).…”

“…The cumulative exposure per cycle to DNG was about 2.2 mg/d, which is comparable to that approved for the treatment of endometriosis (2 mg/d). [8][9][10][11][12] It is likely that the circulating levels of E2 induced by E2V/ DNG, with values ranging between 60 and 90 pg/mL, 32 were not capable to counteract the potent effect of DNG on endometriotic lesions. Large randomized clinical comparative trials on this topic are mandatory.…”

“…[32][33][34][35] In the present study, 10.5% of patients experienced irregular uterine bleedings, which were confined to the first cycle of treatment, and less frequent than those reported for DNG alone. [8][9][10][11][12]16 Effect on quality of life. Pelvic pain, in particular intermenstrual pain and, in lesser extent, menstrual pain, is associated with a reduced quality of life.…”