One year comparison between two add-back therapies in patients treated with a GnRH agonist for symptomatic endometriosis: a randomized double-blind trial
| Autor: | C. Roux, J.L. Meyer, H. Fernandez, B. Hédon, J.M. Mayenga, C. Lucas |
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| Rok vydání: | 2004 |
| Předmět: |
Adult
Agonist medicine.medical_specialty medicine.drug_class Endometriosis Urology Placebo Promegestone Drug Administration Schedule chemistry.chemical_compound Absorptiometry Photon Double-Blind Method Bone Density Leuprorelin Internal medicine medicine Humans Bone mineral Lumbar Vertebrae Intention-to-treat analysis Estradiol business.industry Rehabilitation Obstetrics and Gynecology medicine.disease Osteopenia Treatment Outcome Endocrinology Reproductive Medicine chemistry Drug Therapy Combination Female Leuprolide business medicine.drug |
| Zdroj: | Human Reproduction. 19:1465-1471 |
| ISSN: | 1460-2350 |
| Popis: | BACKGROUND It has been proposed that hormonal supplementation during prolonged GnRH agonist therapy prevents hypoestrogenic side effects, including bone loss. The optimal combination for long-term treatments with safe metabolic profile remains questionable. A norprogesterone derivative, promegestone, was assessed for the first time in a double-blind trial. METHODS Seventy-eight patients with endometriosis with rAFS (Revised American Society for Reproductive Medicine) scores of III-IV were randomly assigned to monthly leuprorelin 3.75 mg (1 year) which, after the third injection was used in combination with promegestone 0.5 mg (P) plus either estradiol placebo (PL) or estradiol 2 mg (E) per day. Bone mineral density (BMD) was determined at baseline, 6 and 12 months, and biological and clinical quarterly assessments were performed. Analysis was by the intention to treat method. RESULTS At month 12, BMD changes from baseline were -6.1 +/- 3.7 and -4.9 +/- 4.0% in the PL-P group, at the spine and hip, respectively. This bone loss was prevented in the E-P group: -1.9 +/- 3.1 and -1.4 +/- 2.3%, respectively (P < 0.0001 inter-group comparisons). The BMD decrease in the E-P group was explained by the changes occurring during the first 6 months of treatment. There was no deleterious change in lipid parameters. Clinical improvement was observed without an inter-group difference. CONCLUSIONS Estradiol 2 mg and promegestone 0.5 mg per day is an effective and safe add-back therapy, which can be proposed for prolonged leuprorelin treatment over 6 months in severe endometriosis. |
| Databáze: | OpenAIRE |
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