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Total Antioxidant Capacity Before and After HRT in Hypotalamic Amenorrhea

Primary Purpose

Hypothalamic Amenorrhea

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
1 mg of transdermal estradiol daily and 10mg of oral MPA
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypothalamic Amenorrhea

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Catholic university of Sacred HeartRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hormonal Replace Therapy

Arm Description

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

Outcomes

Primary Outcome Measures

Total Anti-oxidant Capacity

Secondary Outcome Measures

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

Full Information

First Posted
March 5, 2016
Last Updated
December 3, 2016
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT02984696
Brief Title
Total Antioxidant Capacity Before and After HRT in Hypotalamic Amenorrhea
Official Title
Effects of 6 Months of HRT on Total Antioxidant Capacity in Patients Affected by Hypotalamic Amenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothalamic Amenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hormonal Replace Therapy
Arm Type
Experimental
Arm Description
1 mg of transdermal estradiol daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six months
Intervention Type
Drug
Intervention Name(s)
1 mg of transdermal estradiol daily and 10mg of oral MPA
Primary Outcome Measure Information:
Title
Total Anti-oxidant Capacity
Time Frame
6 Month
Secondary Outcome Measure Information:
Title
Bone Mineral Density
Time Frame
6 Months
Title
Osteocalcin
Time Frame
6 Months
Title
Estrogen levels
Time Frame
6 Months
Title
number of Cycles in 6 months
Description
n° of menstrual cycle
Time Frame
6 Months
Title
beta crosslaps
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Catholic university of Sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosanna Apa, MD
Email
krimisa@libero.it
First Name & Middle Initial & Last Name & Degree
Rosanna Apa, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Total Antioxidant Capacity Before and After HRT in Hypotalamic Amenorrhea

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