Dienogest is as effective as triptorelin in the treatment of endometriosis after laparoscopic surgery: results of a prospective, multicenter, randomized study

Michel Cosson, Cosson M, Denis Querleu, Querleu D, Jacques Donnez, Donnez J, Patrick Madelenat, Madelenat P, Patrick Madélénat, Konincks P, Philippe Konincks, Audebert A, A Audebert, Alain Audebert, Manhes H, Hubert Manhes, H Manhés
Fertility and sterility · 2002 · vol. 77(4) , pp. 684–692 · doi:10.1016/s0015-0282(01)03270-8 · PMID:11937116 · W2023295642
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This prospective, multicenter, randomized study found that dienogest is as effective as triptorelin in treating endometriosis following laparoscopic surgery.

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Abstract

ObjectiveTo compare the efficacy of Dienogest versus Decapeptyl at 3.75 mg as consolidation therapy for surgery in the treatment of endometriosis.DesignMulticenter, open, randomized, parallel-group clinical trial.SettingVolunteer patients in an academic research environment.Patient(s)Women with grade 2, 3, and 4 (</=70) endometriosis at initial laparoscopy.Intervention(s)We provided 16 weeks of treatment with Dienogest, 1 mg tablet daily; or with Decapeptyl, 3.75 mg IM injection every 4 weeks.Main outcome measure(s)A change in the patient's Revised American Fertility Society score at the post-treatment laparoscopy.Result(s)From June 1994 to July 1998, 142 patients were enrolled in the trial. After exclusion for major protocol deviations, 59 patients were included in the Dienogest group and 61 in the Decapeptyl group. This study group was comparable to the first inclusion group. The patient demographic and clinical characteristics, median duration of endometriosis, Revised American Fertility Society scores, and Visual Analogic Squale (VAS) scores were comparable in both groups. Statistical analysis of efficacy was not significantly different between the two groups. Adverse events were reported by 87.7% of patients in the Dienogest group and 85.1% in the Decapeptyl group. Neither treatment affected patient body weight or vital signs.Conclusion(s)Dienogest is as effective as Decapeptyl for consolidation therapy after surgery for the treatment of endometriosis. The safety profile of dienogest differed from Decapeptyl (3.75 mg). Dienogest constitutes a new therapeutic alternative to the GnRH analogues.

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Condition tags

endometriosis

MeSH descriptors

Endometriosis Endometriosis Laparoscopy Nandrolone Nandrolone Triptorelin Pamoate Adolescent Adult Alkaline Phosphatase Alkaline Phosphatase Cholesterol Cholesterol Cholesterol, HDL Cholesterol, HDL Combined Modality Therapy Endometriosis Female Gonadotropin-Releasing Hormone Gonadotropin-Releasing Hormone Hormone Antagonists

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