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Effects of Androgen Administration on Inflammation in Normal Women

Primary Purpose

Hyperandrogenism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dehydroepiandrosterone (DHEA)
Placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperandrogenism focused on measuring Hyperandrogenism, Inflammation, Insulin sensitivity, Body composition

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

DHEA Group

Placebo Group

Arm Description

Oral administration of a capsule containing 130 mg of dehydroepiandrosterone (DHEA) for 5 days.

Oral administration of an identical capsule containing placebo for 5 days.

Outcomes

Primary Outcome Measures

Nuclear factor kappa B (NFkappaB) activation
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
Insulin sensitivity derived from an oral glucose tolerance test (OGTT) will be assessed before and after 5 days of DHEA or placebo administration.

Full Information

First Posted
December 15, 2012
Last Updated
November 14, 2013
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01753037
Brief Title
Effects of Androgen Administration on Inflammation in Normal Women
Official Title
Effects of Oral Androgen Administration on Hyperglycemia-Induced Inflammation in Lean Reproductive-Age Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperandrogenism
Keywords
Hyperandrogenism, Inflammation, Insulin sensitivity, Body composition

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DHEA Group
Arm Type
Active Comparator
Arm Description
Oral administration of a capsule containing 130 mg of dehydroepiandrosterone (DHEA) for 5 days.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Oral administration of an identical capsule containing placebo for 5 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dehydroepiandrosterone (DHEA)
Intervention Description
DHEA 130 mg administered orally for 5 days.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo contained in a capsule that is identical in appearance to the one used to package DHEA for 5 days.
Primary Outcome Measure Information:
Title
Nuclear factor kappa B (NFkappaB) activation
Description
White blood cell NFkappaB activation will be assessed in response to glucose ingestion before and after 5 days of DHEA or placebo administration.
Time Frame
0 and 2 hours after glucose ingestion
Secondary Outcome Measure Information:
Title
Insulin sensitivity
Description
Insulin sensitivity derived from an oral glucose tolerance test (OGTT) will be assessed before and after 5 days of DHEA or placebo administration.
Time Frame
0 and 5 days after DHEA or placebo

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank González, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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Effects of Androgen Administration on Inflammation in Normal Women

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