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Total Antioxidant Capacity Before and After HRT in Hypotalamic Amenorrhea

NCT ID: NCT02984696

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Hypothalamic Amenorrhea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hormonal Replace Therapy

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Rosanna Apa

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catholic university of Sacred Heart

Rome, Rome, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Rosanna Apa, MD

Role: primary

Other Identifiers

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Hypotalamic Amenorrhea-01

Identifier Type: -

Identifier Source: org_study_id