drugset / Trial / NCT00458458

Treatment of Endometriosis With Norethindrone Acetate ( NA) VS. Gonadotropin- Releasing Hormone (GnRH) Agonist (Lupron Depot 11.25 mg)

NCT00458458

RandomizedParallel-groupDouble-blindTreatment

Summary

(A) Major 1) to compare the effectiveness of norethindrone acetate (NA) with GnRH agonist (Lupron-Depot-3) in relieving symptoms of endometriosis, 2) to compare bone density in the two treated groups in order to demonstrate that NA does not affect bone density; (B) Minor: 1) To compare the lipid profiles of patients in the two groups to confirm the hypothesis that the effects of NA and GnRH agonists on lipid profiles are similar, 2) To determine whether quality of life, assessed by questionnaire, is better in patients assigned to NA than in patients assigned to GnRH, 3) To determine whether NA has fewer adverse effects than GnRH agonist.

Timeline

Start
2004-08
Primary completion
2012-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Leuprolide Other / unclassified 11.25 mg Intramuscular
Comparator Norethindrone Unknown 5 mg Oral