Evaluation of Oral Lipid Ingestion in Relation to Ovarian Androgen Secretion in Polycystic Ovary Syndrome (PCOS)

• Status: Terminated
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine the relationship between lipid-induced inflammation and ovarian androgen secretion in women with polycystic ovary syndrome (PCOS); and to examine the effect of salsalate and polygonum cuspidatum extract (PCE) containing resveratrol on lipid-induced inflammation, ovarian androgen secretion, body composition and ovulation in a subset of normal weight women with PCOS.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Indiana University
• Treatments: Salicylsalicylic acid; Sodium Salicylate

Criteria

General Inclusion Criteria:

• Acceptable health based on interview, medical history, physical examination, and lab tests

• Ability to comply with the requirements of the study

• Ability and willingness to provide signed, witnessed informed consent

Inclusion Criteria for PCOS:

• Between the ages of 18-40 years

• Body mass index between 18 and 25, or between 30 and 40

• Less than or equal to 8 periods annually

• An elevated serum androgen level or skin manifestations of androgen excess

• Normal thyroid function tests and normal prolactin level

• Exclusion of late-onset adrenal hyperplasia

Inclusion Criteria for Ovulatory Controls:

• Between the ages of 18-40 years

• Body mass index between 18 and 25, or between 30 and 40

• 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 6 weeks prior to study entry) injection of any drugs known or suspected to affect reproductive function including oral contraceptives, metformin, thiazolidinediones, glucocorticoids, GnRH-agonists, or anti-androgens (spironolactone, flutamide, etc)

• Documented or suspected history of use of recent (within one year) illicit drug abuse or alcoholism

• Tobacco smoking if salsalate or PCE will be administered

• Ingestion of any investigational drugs within 4 weeks prior to study onset

• Pregnancy or lactation (less than or equal to 6 weeks postpartum)