Equivalence of the 3-month and 28-day formulations of triptorelin with regard to achievement and maintenance of medical castration in women with endometriosis

Jacques Donnez, Donnez J, P. Dewart, Paul J Dewart, Dewart PJ, Hedon B, Bernard Hedon, B. Hédon, A Perino, Antonio Perino, Schindler AE, Adolf E. Schindler, Blumberg J, Joëlle Blumberg, Denis Querleu, Querleu D
Fertility and sterility · 2004 · vol. 81(2) , pp. 297–304 · doi:10.1016/j.fertnstert.2003.07.013 · PMID:14967363 · W2068104402
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This study assessed whether the 3-month and 28-day triptorelin formulations were equivalent in achieving and maintaining medical castration in women diagnosed with endometriosis.

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Abstract

OBJECTIVE: The present study aims at demonstrating the equivalence of the 28-day and 3-month formulations of triptorelin SR (sustained release) in terms of percentage of patients achieving castration levels of estradiol (<==50 pg/mL) 84 days after treatment initiation. DESIGN: A phase II, prospective, randomized, multicenter, open study was conducted in two parallel groups of women with endometriosis. SETTING: Academic hospitals. PATIENT(S): Seventy-two women with endometriosis. were treated with a single intramuscular injection of 3-month triptorelin SR, and 74 patients were treated with one intramuscular injection of 28-day triptorelin SR every 28 days for 3 months. INTERVENTION(S): As part of two parallel treatment groups, 72 women were given a single intramuscular injection of 3-month triptorelin SR, and 74 women were given one intramuscular injection of 28-day triptorelin SR every 28 days for 3 months. MAIN OUTCOME MEASURE(S): Percentage of patients achieving castration levels of estradiol at the end of the treatment period. RESULT(S): Patients participated in the study until resumption of menses. Ninety-seven percent of patients given the 3-month formulation and 94% of those given the 28-day formulation were in a state of medical castration on day 84. The mean time to achieve castration was shorter for the 3-month formulation, and the duration of castration was significantly longer. The FSH and LH parameters were comparable, though not always identical. CONCLUSION(S): The pharmacodynamic effects of the Decapeptyl SR 3-month formulation are equivalent to those of the 28-day formulation. The 3-month formulation provides the added advantage of a longer maintenance of medical castration in women who have endometriosis.

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Condition tags

endometriosis

MeSH descriptors

Endometriosis Triptorelin Pamoate Adult Adult Chemistry, Pharmaceutical Chemistry, Pharmaceutical Drug Administration Schedule Drug Administration Schedule Endometriosis Endometriosis Estradiol Estradiol Estradiol Female Female Follicle Stimulating Hormone Follicle Stimulating Hormone Follicle Stimulating Hormone Humans Humans

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