Dydrogesterone and Endometriosis

Abstract

Summary The results are reported of the administration of dydrogesterone, 5 mg twice daily, to 49 patients with endometriosis. All but five patients were symptom‐free after nine months of therapy. Most subjective symptoms had disappeared within four to eight weeks; dyspareunia usually took longer. In 30 out of 32 patients who had a culdoscopy after one or two treatment courses, a ‘cure’ of endometriosis was confirmed. Ten out of nineteen infertile patients became pregnant following treatment. The only side‐effects were transient mastalgia and dizziness in two patients. No amenorrhoea or other disturbances of the menstrual cycle were reported.

A multicentre phase III study comparing efficacy & safety of novel extended-release vs. conventional formulation of Dydrogesterone in Indian patients with endometriosis

“…The majority of women reported a signi cant decrease in the quantity and/or intensity of symptoms across studies, and laparoscopic inspection corroborated these results in many trials. [22][23][24] This prospective, randomized, double-blind study evaluated the once-daily extended-release dydrogesterone 20 mg in comparison to dydrogesterone 10 mg twice daily in women with endometriosis. We observed signi cant and similar improvements in EAPP in both arms.…”

“…[9] As per the approved package insert of dydrogesterone, it has to be used in a dose of 10 mg to be taken two times daily for the management of endometriosis. [10] Taking these tablets two times in a day may lead to inconvenience and non-compliance, thus impacting the e cacy of the drug in real-world clinical practice. Taking this into consideration, an extended-release (ER), once-daily formulation of dydrogesterone 20 mg has been developed by M/s Zydus Healthcare Limited.…”

A multicentre phase III study comparing efficacy and safety of novel extended-release versus conventional formulation of dydrogesterone in Indian patients with endometriosis

“…The majority of women reported a significant decrease in the quantity and/or intensity of symptoms across studies, and laparoscopic inspection corroborated these results in many trials. [22][23][24] This prospective, randomized, double-blind study evaluated the once-daily extended-release dydrogesterone 20 mg in comparison to dydrogesterone 10 mg twice daily in women with endometriosis. We observed significant and similar improvements in EAPP in both arms.…”

“…9 As per the approved package insert of dydrogesterone, it has to be used in a dose of 10 mg to be taken two times daily for the management of endometriosis. 10 Taking these tablets two times in a day may lead to inconvenience and non-compliance, thus impacting the efficacy of the drug in real-world clinical practice. Taking this into consideration, an extended-release (ER), once-daily formulation of dydrogesterone 20 mg has been developed by M/s Zydus Healthcare Limited.…”

Dydrogesterone as an Option in the Medical Treatment of Endometriosis: A Brief Comment

“…The earlier results of the application of dydrogesterone in women with endometriosis were published more than four decades ago, 7 but such a use has been notedly explored with more interest in the last fifteen years. The study by Trivedi et al (2007) 8 was the first to convincingly demonstrate significant improvements in pelvic pain, dysmenorrhea and dyspareunia, and a 74% rate of satisfaction in the postlaparoscopic follow-up at 3 to 6 months.…”