- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02984696
Total Antioxidant Capacity Before and After HRT in Hypotalamic Amenorrhea
December 3, 2016 updated by: Rosanna Apa, Catholic University of the Sacred Heart
Effects of 6 Months of HRT on Total Antioxidant Capacity in Patients Affected by Hypotalamic Amenorrhea
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Rome, Italy, 00168
- Recruiting
- Catholic University Of Sacred Heart
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Principal Investigator:
- Rosanna Apa, MD
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Contact:
- Rosanna Apa, MD
- Email: krimisa@libero.it
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 33 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total Anti-oxidant Capacity
Time Frame: 6 Month
|
6 Month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bone Mineral Density
Time Frame: 6 Months
|
6 Months
|
|
Osteocalcin
Time Frame: 6 Months
|
6 Months
|
|
Estrogen levels
Time Frame: 6 Months
|
6 Months
|
|
number of Cycles in 6 months
Time Frame: 6 Months
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n° of menstrual cycle
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6 Months
|
beta crosslaps
Time Frame: 6 months
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
October 1, 2016
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
March 5, 2016
First Submitted That Met QC Criteria
December 3, 2016
First Posted (Estimate)
December 7, 2016
Study Record Updates
Last Update Posted (Estimate)
December 7, 2016
Last Update Submitted That Met QC Criteria
December 3, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hypotalamic Amenorrhea-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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