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

Fertil Steril. 2004 Feb;81(2):297-304. doi: 10.1016/j.fertnstert.2003.07.013.

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Chemistry, Pharmaceutical
  • Drug Administration Schedule
  • Endometriosis / drug therapy*
  • Estradiol / blood
  • Female
  • Follicle Stimulating Hormone / blood
  • Humans
  • Injections, Intramuscular
  • Luteinizing Hormone / blood
  • Luteolytic Agents / adverse effects
  • Luteolytic Agents / therapeutic use
  • Recurrence
  • Time Factors
  • Triptorelin Pamoate / administration & dosage
  • Triptorelin Pamoate / adverse effects
  • Triptorelin Pamoate / therapeutic use*

Substances

  • Luteolytic Agents
  • Triptorelin Pamoate
  • Estradiol
  • Luteinizing Hormone
  • Follicle Stimulating Hormone