Total Antioxidant Capacity Before and After HRT in Hypotalamic Amenorrhea

Sponsor

Catholic University of the Sacred Heart (Other)

Overall Status

Unknown status

CT.gov ID

NCT02984696

Collaborator

(none)

Enrollment

Location

Arm

33.1

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypothalamic Amenorrhea	Drug: 1 mg of transdermal estradiol daily and 10mg of oral MPA	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Oct 1, 2016

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: 1 mg of transdermal estradiol daily and 10mg of oral MPA

Arm

Intervention/Treatment

Experimental: 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

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

Outcome Measures

Primary Outcome Measures

Total Anti-oxidant Capacity [6 Month]

Secondary Outcome Measures

Bone Mineral Density [6 Months]
Osteocalcin [6 Months]
Estrogen levels [6 Months]
number of Cycles in 6 months [6 Months]
n° of menstrual cycle
beta crosslaps [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Catholic university of Sacred Heart	Rome		Italy	00168

Sponsors and Collaborators

Catholic University of the Sacred Heart

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rosanna Apa, Professor, Catholic University of the Sacred Heart

ClinicalTrials.gov Identifier:

NCT02984696

Other Study ID Numbers:

Hypotalamic Amenorrhea-01

First Posted:

Dec 7, 2016

Last Update Posted:

Dec 7, 2016

Last Verified:

Dec 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Amenorrhea

Estradiol

Study Results

No Results Posted as of Dec 7, 2016