Hypothalamic Amenorrhea Clinical Trial
Official title:
Effects of 6 Months of HRT on Total Antioxidant Capacity in Patients Affected by Hypotalamic Amenorrhea
The aim of our study is to investigate the effects of 6 months oh HRT on total anti-oxidant capacity, clinical, endocrine and metabolic features in women affected by hypotalamic amenorrhea. The study group included 20 patients treated with 1 mg of transdermal estradiol daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six months. Menstrual pattern, anthropometric parameters, hormonal assays, DXA and bone metabolism parameters are evaluated before and after therapy.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 2017 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Hypotalamic Amenorrhea Exclusion Criteria: - diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test) - hypertension - significant liver or renal impairment - other hormonal dysfunction (hypothalamic, pituitary, PCOS, thiroidal or adrenal) - neoplasms |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Catholic university of Sacred Heart | Rome |
Lead Sponsor | Collaborator |
---|---|
Catholic University of the Sacred Heart |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Anti-oxidant Capacity | 6 Month | No | |
Secondary | Bone Mineral Density | 6 Months | No | |
Secondary | Osteocalcin | 6 Months | No | |
Secondary | Estrogen levels | 6 Months | No | |
Secondary | number of Cycles in 6 months | n° of menstrual cycle | 6 Months | No |
Secondary | beta crosslaps | 6 months | No |
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