Total Antioxidant Capacity Before and After HRT in Hypota... | NCT02984696

Studies
Total Antioxidant Capacity Before and After HRT in Hypotalamic Amenorrhea

NCT02984696

Sponsor

Catholic University of the Sacred Heart

Status

Unknown status

Last Update Posted

Dec 7, 2016Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Hypothalamic Amenorrhea

Interventions

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

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Oct 2016Actual

Completion Date

Dec 2017Estimated

First Submitted Date

Mar 5, 2016

First Submission Date that Met QC Criteria

Dec 3, 2016

First Posted Date

Dec 7, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2016

Last Update Posted Date

Dec 7, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rosanna Apa, Professor, Catholic University of the Sacred HeartPrincipal Investigator

Lead Sponsor

Catholic University of the Sacred HeartOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hormonal Replace Therapy	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
1 mg of transdermal estradiol daily and 10mg of oral MPA	Drug		Hormonal Replace Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Anti-oxidant Capacity		6 Month

Secondary Outcomes

Measure	Description	Time Frame
Bone Mineral Density		6 Months
Osteocalcin		6 Months
Estrogen levels

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Catholic university of Sacred Heart	Recruiting	Rome	Rome	00168	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided