One year comparison between two add-back therapies in patients treated with a GnRH agonist for symptomatic endometriosis: a randomized double-blind trial

H Fernandez, H. Fernández, C Lucas, B Hédon, J L Meyer, J M Mayenga, C Roux
Human Reproduction · 2004 · vol. 19(6) , pp. 1465–1471 · doi:10.1093/humrep/deh250 · PMID:15105403 · W2130626925
article OA: bronze CC0 ⤵ 34 in-corpus citations
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⚙ AI-generated summary by claude@2026-06, 2026-06-06 ⓘ

This trial found that adding estradiol and promegestone to GnRH agonist therapy prevented bone loss and improved endometriosis symptoms without adverse metabolic changes.

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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: 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.

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Condition tags

endometriosis

MeSH descriptors

Endometriosis Estradiol Leuprolide Promegestone Absorptiometry, Photon Adult Bone Density Bone Density Double-Blind Method Drug Administration Schedule Drug Therapy, Combination Endometriosis Endometriosis Estradiol Estradiol Estradiol Female Humans Leuprolide Leuprolide

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References (28)

Cited by (34)

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