EFFICACY AND TOLERABILITY OF TWO REPLACEMENT THERAPIES FOR AMENORRHEA IN CHILDREN TREATED FOR CANCER

INTERVENTION: Pharmaceutical Form: Tablet Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 10‐ Trade Name: PROVERA G Pharmaceutical Form: Tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Trade Name: PROVERA G Pharmaceutical Form: Tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Trade Name: ESTRADERM TTS 25 Pharmaceutical Form: Transdermal patch Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50‐ Trade Name: ESTRADERM TTS 25 Pharmaceutical Form: Transdermal patch Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 25‐ CONDITION: primary and secundary amenorrhea ; MedDRA version: 9.1 Level: LLT Classification code 10001928 Term: Amenorrhoea PRIMARY OUTCOME: Main Objective: 1. PRIMARY AMENORRHEA BETTER STATURE AND WEIGHT GROWTH 2. SECONDARY AMENORRHEA INCREASE OF BOND MINERALIZATION Primary end point(s): 1. PRIMARY AMENORRHEA BETTER STATURE AND WEIGHT GROWTH 2. SECONDARY AMENORRHEA INCREASE OF BOND MINERALIZATION Secondary Objective: EVALUATION OF EFFECTS ON 1. LIVER METABOLISM 2. BONE METABOLISM 3. GH‐IGF1‐IGFBP‐3 AXIS 4. LIPID METABOLISM 5. GLUCOSE METABOLISM INCLUSION CRITERIA: WOMEN BETWEEN 12 AND 25 YEARS OLD WHO WERE TREATED FOR CANCER IN CHILDHOOD AND DEVELOPED HYPER OR HYPOGONADOTROPIC HYPOGONADISM Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range