Total Antioxidant Capacity Before and After HRT in Hypotalamic Amenorrhea

Hypothalamic Amenorrhea Clinical Trial

Official title:

Effects of 6 Months of HRT on Total Antioxidant Capacity in Patients Affected by Hypotalamic Amenorrhea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02984696
• Other study ID #: Hypotalamic Amenorrhea-01
• Status: Recruiting
• Phase: N/A
• First received: March 5, 2016
• Last updated: December 3, 2016
• Start date: March 2015
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Catholic University of Sacred heart.
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amenorrhea
• Hypothalamic Amenorrhea

Intervention

Drug:
• 1 mg of transdermal estradiol daily and 10mg of oral MPA

Locations

Country	Name	City	State
Italy	Catholic university of Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

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