Dienogest is as effective as triptorelin in the treatment of endometriosis after laparoscopic surgery: results of a prospective, multicenter, randomized study.
OBJECTIVE
To compare the efficacy of Dienogest versus Decapeptyl at 3.75 mg as consolidation therapy for surgery in the treatment of endometriosis.


METHODS
Multicenter, open, randomized, parallel-group clinical trial.


METHODS
Volunteer patients in an academic research environment.


METHODS
Women with grade 2, 3, and 4 (</=70) endometriosis at initial laparoscopy.


METHODS
We provided 16 weeks of treatment with Dienogest, 1 mg tablet daily; or with Decapeptyl, 3.75 mg IM injection every 4 weeks.


METHODS
A change in the patient's Revised American Fertility Society score at the post-treatment laparoscopy.


RESULTS
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.


CONCLUSIONS
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.
Cosson
Michel
M
Department of Gynecologic Surgery, Maternité Jeanne de Flandres, Lille, France. cosson@chru-lille.fr
Querleu
Denis
D
Donnez
Jacques
J
Madelenat
Patrick
P
Konincks
Philippe
P
Audebert
Alain
A
Manhes
Hubert
H
D000293:Adolescent; D000328:Adult; D000469:Alkaline Phosphatase / Q000097:blood; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D003131:Combined Modality Therapy; D004715:Endometriosis / Q000188:drug therapy* / Q000601:surgery*; D005260:Female; D007987:Gonadotropin-Releasing Hormone / Q000819:agonists; D006727:Hormone Antagonists / Q000627:therapeutic use; D006801:Humans; D010535:Laparoscopy; D009277:Nandrolone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D017329:Triptorelin Pamoate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D008076:Cholesterol, HDL; D006727:Hormone Antagonists; D017329:Triptorelin Pamoate; D007987:Gonadotropin-Releasing Hormone; C023635:dienogest; D009277:Nandrolone; D002784:Cholesterol; D000469:Alkaline Phosphatase