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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000995-18-IT

Enrollment

Registered

2007-04-06

Start date

2007-06-25

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary and secundary amenorrhea MedDRA version: 9.1 Level: LLT Classification code 10001928 Term: Amenorrhoea

Interventions

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(

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. off therapy less than 6 months 2. patients with chromosomal anomalies Down, Turner, Fanconi

Design outcomes

Primary

Measure	Time frame
Main Objective: 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;Primary end point(s): 1. PRIMARY AMENORRHEA BETTER STATURE AND WEIGHT GROWTH 2. SECONDARY AMENORRHEA INCREASE OF BOND MINERALIZATION	—

Measure

Time frame

Main Objective: 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;Primary end point(s): 1. PRIMARY AMENORRHEA BETTER STATURE AND WEIGHT GROWTH 2. SECONDARY AMENORRHEA INCREASE OF BOND MINERALIZATION

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026