Total Antioxidant Capacity Before and After HRT in Hypotalamic Amenorrhea
Not Applicable
- Conditions
- Hypothalamic Amenorrhea
- Interventions
- Drug: 1 mg of transdermal estradiol daily and 10mg of oral MPA
- Registration Number
- NCT02984696
- Lead Sponsor
- Catholic University of the Sacred Heart
- 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 Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hormonal Replace Therapy 1 mg of transdermal estradiol daily and 10mg of oral MPA 1 mg of transdermal estradiol daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six months
- Primary Outcome Measures
Name Time Method Total Anti-oxidant Capacity 6 Month
- Secondary Outcome Measures
Name Time Method Osteocalcin 6 Months Bone Mineral Density 6 Months Estrogen levels 6 Months beta crosslaps 6 months number of Cycles in 6 months 6 Months n° of menstrual cycle
Trial Locations
- Locations (1)
Catholic university of Sacred Heart
🇮🇹Rome, Italy