Effects of Androgen Administration on Inflammation in Normal Women

Mayo Clinic

Status: Completed

Conditions: Hyperandrogenism

Treatments: Dietary Supplement: Dehydroepiandrosterone (DHEA); Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01753037

Mayo-06-004680

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

DHEA Group

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Dehydroepiandrosterone (DHEA)

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo