Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of Androgen Administration on Inflammation in Normal Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frank Gonzalez, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01753037
First received: December 15, 2012
Last updated: November 14, 2013
Last verified: December 2012
  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 Blind (Subject, 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 Mayo Clinic:

Primary Outcome Measures:
  • Nuclear factor kappa B (NFkappaB) activation [ Time Frame: 0 and 2 hours after glucose ingestion ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Frank Gonzalez, Study Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01753037     History of Changes
Other Study ID Numbers: Mayo-06-004680
Study First Received: December 15, 2012
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 24, 2014