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A multicenter, randomized, double-blind, active-controlled, parallel group, 2-arm study to investigate the effect of estradiol valerate/dienogest compared to Microgynon on hormone withdrawal associate...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-003226-42

A multicenter, randomized, double-blind, active-controlled, parallel group, 2-arm study to investigate the effect of estradiol valerate/dienogest compared to Microgynon on hormone withdrawal associated symptoms in otherwise healthy women after 6 cycles of treatment "Estudio multicéntrico, aleatorizado, doble ciego, con control activo, con 2 grupos de tratamiento paralelos, para investigar el efecto de estradiol valerato / dienogest comparado con Microgynon, en los síntomas asociados al periodo sin hormona en mujeres sanas, después de 6 ciclos de tratamiento”

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Extrait

To show superiority to Microgynon with regard to changes in frequency and intensity of the hormone withdrawal associated symptoms headache and pelvic pain on cycle days 22-28 from baseline to cycle 6 in approximately 880 women.

Critère d'inclusion

  • Hormone withdrawal associated symptoms of headache and pelvic pain suffered by patients receiving LNG containing oral contraception,Pacientes en tratamiento con un anticonceptivo oral con LNG que manifiestan síntomas de dolor pélvico o cefalea relacionados con la privación hormonal

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