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Effects of Androgen Administration on Inflammation in Normal Women

NCT ID: NCT01753037

Last Updated: 2013-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-04-30

Brief Summary

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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

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Conditions

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Hyperandrogenism

Keywords

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Hyperandrogenism Inflammation Insulin sensitivity Body composition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DHEA Group

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

Group Type ACTIVE_COMPARATOR

Dehydroepiandrosterone (DHEA)

Intervention Type DIETARY_SUPPLEMENT

DHEA 130 mg administered orally for 5 days.

Placebo Group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Dehydroepiandrosterone (DHEA)

DHEA 130 mg administered orally for 5 days.

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Frank Gonzalez

Study Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frank González, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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Mayo-06-004680

Identifier Type: -

Identifier Source: org_study_id