Clinical efficacy and safety: genitourinary system and sex hormones

The European Medicines Agency's scientific guidelines on the clinical evaluation of human medicines used in conditions affecting the genitourinary system and sex hormones help medicine developers prepare marketing authorisation applications.

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

Guidelines

• Clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in postmenopausal women - Scientific guideline
• Clinical investigation of medicinal products in the treatment of urinary incontinence
• Clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency - Scientific guideline
• Clinical investigation of steroid contraceptives in women