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Total Antioxidant Capacity Before and After HRT in Hypotalamic Amenorrhea

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ClinicalTrials.gov Identifier: NCT02984696
Recruitment Status : Recruiting
First Posted : December 7, 2016
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
Rosanna Apa, Catholic University of the Sacred Heart

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : March 2015
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants
Drug Information available for: Estradiol

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



Primary Outcome Measures :
  1. Total Anti-oxidant Capacity [ Time Frame: 6 Month ]

Secondary Outcome Measures :
  1. Bone Mineral Density [ Time Frame: 6 Months ]
  2. Osteocalcin [ Time Frame: 6 Months ]
  3. Estrogen levels [ Time Frame: 6 Months ]
  4. number of Cycles in 6 months [ Time Frame: 6 Months ]
    n° of menstrual cycle

  5. beta crosslaps [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984696


Locations
Italy
Catholic university of Sacred Heart Recruiting
Rome, Italy, 00168
Contact: Rosanna Apa, MD       krimisa@libero.it   
Principal Investigator: Rosanna Apa, MD         
Sponsors and Collaborators
Catholic University of the Sacred Heart

Responsible Party: Rosanna Apa, Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT02984696     History of Changes
Other Study ID Numbers: Hypotalamic Amenorrhea-01
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Amenorrhea
Menstruation Disturbances
Pathologic Processes
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Antioxidants
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Molecular Mechanisms of Pharmacological Action
Protective Agents