Effects of Androgen Administration on Inflammation in Normal Women

Not Applicable

Completed

• Conditions: Hyperandrogenism
• Interventions: Dietary Supplement: Dehydroepiandrosterone (DHEA); Other: Placebo

• Registration Number: NCT01753037
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2012-12
• Study First Submitted: 2012-12-15
• Study First Submitted QC: 2012-12-15
• Study First Posted: 2012-12-20
• Last Update Submitted: 2013-11-14
• Last Update Posted: 2013-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DHEA Group	Dehydroepiandrosterone (DHEA)	Oral administration of a capsule containing 130 mg of dehydroepiandrosterone (DHEA) for 5 days.
Placebo Group	Placebo	Oral administration of an identical capsule containing placebo for 5 days.

Primary Outcome Measures

Name	Time	Method
Nuclear factor kappa B (NFkappaB) activation	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

Name	Time	Method
Insulin sensitivity	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States