Abstract | 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:
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Authors | H Fernandez, C Lucas, B Hédon, J L Meyer, J M Mayenga, C Roux |
Journal | Human reproduction (Oxford, England)
(Hum Reprod)
Vol. 19
Issue 6
Pg. 1465-71
(Jun 2004)
ISSN: 0268-1161 [Print] England |
PMID | 15105403
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Estradiol
- Promegestone
- Leuprolide
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Topics |
- Absorptiometry, Photon
- Adult
- Bone Density
(drug effects)
- Double-Blind Method
- Drug Administration Schedule
- Drug Therapy, Combination
- Endometriosis
(drug therapy, metabolism)
- Estradiol
(administration & dosage, adverse effects, therapeutic use)
- Female
- Humans
- Leuprolide
(administration & dosage, adverse effects, therapeutic use)
- Lumbar Vertebrae
(metabolism, radiation effects)
- Promegestone
(administration & dosage, adverse effects, therapeutic use)
- Treatment Outcome
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