Clinical Trial: Total Antioxidant Capacity Before and After HRT in Hypotalamic Amenorrhea
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Effects of 6 Months of HRT on Total Antioxidant Capacity in Patients Affected by Hypotalamic Amenorrhea
Brief Summary: 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.
Detailed Summary:
Sponsor: Catholic University of the Sacred Heart
Current Primary Outcome: Total Anti-oxidant Capacity [ Time Frame: 6 Month ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Bone Mineral Density [ Time Frame: 6 Months ]
- Osteocalcin [ Time Frame: 6 Months ]
- Estrogen levels [ Time Frame: 6 Months ]
- number of Cycles in 6 months [ Time Frame: 6 Months ]n° of menstrual cycle
- beta crosslaps [ Time Frame: 6 months ]
Original Secondary Outcome: Same as current
Information By: Catholic University of the Sacred Heart
Dates:
Date Received: March 5, 2016
Date Started: March 2015
Date Completion: December 2017
Last Updated: December 3, 2016
Last Verified: December 2016
