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Effects of Androgen Administration on Inflammation in Normal Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01753037
First Posted: December 20, 2012
Last Update Posted: November 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Frank Gonzalez, Mayo Clinic
  Purpose
The hypothesis of this study is that DHEA administration to increase male hormone in healthy normal-weight young women to levels present in women with Polycystic Ovary Syndrome will cause an inflammatory response in white blood cells in the fasting state, and in response to glucose ingestion.

Condition Intervention
Hyperandrogenism Dietary Supplement: Dehydroepiandrosterone (DHEA) Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Oral Androgen Administration on Hyperglycemia-Induced Inflammation in Lean Reproductive-Age Women

Resource links provided by NLM:


Further study details as provided by Frank Gonzalez, Mayo Clinic:

Primary Outcome Measures:
  • Nuclear factor kappa B (NFkappaB) activation [ Time Frame: 0 and 2 hours after glucose ingestion ]
    White blood cell NFkappaB activation will be assessed in response to glucose ingestion before and after 5 days of DHEA or placebo administration.


Secondary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 0 and 5 days after DHEA or placebo ]
    Insulin sensitivity derived from an oral glucose tolerance test (OGTT) will be assessed before and after 5 days of DHEA or placebo administration.


Enrollment: 25
Study Start Date: December 2006
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DHEA Group
Oral administration of a capsule containing 130 mg of dehydroepiandrosterone (DHEA) for 5 days.
Dietary Supplement: Dehydroepiandrosterone (DHEA)
DHEA 130 mg administered orally for 5 days.
Placebo Comparator: Placebo Group
Oral administration of an identical capsule containing placebo for 5 days.
Other: Placebo
Placebo contained in a capsule that is identical in appearance to the one used to package DHEA for 5 days.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Acceptable health based on interview, medical history, physical examination and lab tests
  • Ability to comply with requirements of the study
  • Ability and willingness to provide signed, witnessed informed consent
  • Between the ages of 18-40 years
  • Body mass index between 18 and 25
  • Normal regular monthly periods
  • No clinical evidence of androgen excess
  • No evidence of polycystic ovaries on ultrasound

Exclusion Criteria:

  • Diabetes mellitus
  • Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious and malignant disease
  • High blood pressure
  • Current or recent (within 30 days prior to study entry) use of any drugs known or suspected to affect reproductive function including oral contraceptives, metformin, gonadotropin releasing hormone agonists, or anti-androgens (spironolactone, flutamide, etc.)
  • Use of medications that have an adverse drug interaction with DHEA therapy including antipsychotics, phenothiazines, lithium, selective serotonin reuptake inhibitors, triazolam, estrogen or testosterone formulations
  • Known hypersensitivity to DHEA
  • Two first-degree relatives with breast cancer or ovarian cancer
  • Documented or suspected history of recent (within 1 year) illicit drug abuse or alcoholism
  • Tobacco smoking
  • Ingestion of any investigational drugs within 4 weeks prior to study onset
  • Pregnancy or lactation (less than or equal to 6 weeks postpartum)
  Contacts and Locations
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): NCT01753037


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Frank González, M.D. Mayo Clinic
  More Information

Responsible Party: Frank Gonzalez, Study Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01753037     History of Changes
Other Study ID Numbers: Mayo-06-004680
First Submitted: December 15, 2012
First Posted: December 20, 2012
Last Update Posted: November 18, 2013
Last Verified: December 2012

Keywords provided by Frank Gonzalez, Mayo Clinic:
Hyperandrogenism
Inflammation
Insulin sensitivity
Body composition

Additional relevant MeSH terms:
Inflammation
Hyperandrogenism
Pathologic Processes
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Adrenogenital Syndrome
Congenital Abnormalities
Gonadal Disorders
Endocrine System Diseases
Androgens
Dehydroepiandrosterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors