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| Document type |
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Article de périodique (Journal article) – Clinical Trial, Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
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| Abstract |
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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 date |
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2004 |
| Journal information |
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"Fertility and sterility" - Vol. 81, no. 2, p. 297-304 (2004) |
| Peer reviewed |
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yes |
| issn |
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0015-0282 |
| Publication status |
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Publié |
| Affiliation |
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UCL
- MD/GYPE - Département de gynécologie, d'obstétrique et de pédiatrie
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| MESH Subject |
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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 - therapeutic use ; Recurrence ; Time Factors ; Triptorelin - administration & dosage - adverse effects - therapeutic use
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