Effects of Androgen Administration on Inflammation in Normal Women

Hyperandrogenism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753037
• Other study ID #: Mayo-06-004680
• Status: Completed
• Phase: N/A
• First received: December 15, 2012
• Last updated: November 14, 2013
• Start date: December 2006
• Est. completion date: April 2010

Study information

• Verified date: December 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hyperandrogenism
• Inflammation

Intervention

Dietary Supplement:
• Dehydroepiandrosterone (DHEA)
DHEA 130 mg administered orally 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0 and 2 hours after glucose ingestion	No
Secondary	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.	0 and 5 days after DHEA or placebo	No