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OpenTrials
Completed

NCT Number: NCT01753037

Effects of Androgen Administration on Inflammation in Normal Women

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

dehydroepiandrosterone (DHEA)

Dietary Supplement

DHEA 130 mg administered orally for 5 days.

Placebo

Other

Placebo contained in a capsule that is identical in appearance to the one used to package DHEA for 5 days.

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Effects of Oral Androgen Administration on Hyperglycemia-Induced Inflammation in Lean Reproductive-Age Women

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Dec 20, 2012
Registry last updated
Nov 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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