Total Antioxidant Capacity Before and After HRT in Hypotalamic Amenorrhea

Catholic University of the Sacred Heart

Status: Unknown

Conditions: Hypothalamic Amenorrhea

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02984696

Hypotalamic Amenorrhea-01

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Hormonal Replace Therapy

Experimental group

Description:

1 mg of transdermal estradiol daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six months

Treatment:

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