Clinical trial · Interventional
Evaluation of Oral Lipid Ingestion in Relation to Ovarian Androgen Secretion in Polycystic Ovary Syndrome (PCOS)
Evaluation of the Ovarian Dynamic Response and the Inflammatory Response to Oral Lipid Challenge in Relation to Body Composition in Polycystic Ovary Syndrome
NCT01489319CI-TRIAL-00025928ELI-ROASterminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The PI left Indiana University. The findings served as preliminary data for a recently awarded NIH R01 grant.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Salsalate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Nl Wt PCOS - Nl Abdominal Adiposity
- description
- 10 normal weight women with PCOS who have normal abdominal adiposity established by DEXA
- interventionNames
- Drug: Salsalate
- type
- EXPERIMENTAL
- label
- Nl Wt PCOS - Increased Abdominal Adiposity
- description
- 10 normal weight women with PCOS who have increased abdominal adiposity established by DEXA
- interventionNames
- Drug: Salsalate
- type
- NO_INTERVENTION
- label
- Obese PCOS
- description
- 10 obese women with PCOS
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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)
References
Publications (3)
- DERIVEDGonzalez F, Considine RV, Abdelhadi OA, Acton AJ. Lipid-induced mononuclear cell cytokine secretion in the development of metabolic aberration and androgen excess in polycystic ovary syndrome. Hum Reprod. 2020 May 1;35(5):1168-1177. doi: 10.1093/humrep/deaa056. PMID 32325487
- DERIVEDGonzalez F, Considine RV, Abdelhadi OA, Acton AJ. Inflammation Triggered by Saturated Fat Ingestion Is Linked to Insulin Resistance and Hyperandrogenism in Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2020 Jun 1;105(6):e2152-67. doi: 10.1210/clinem/dgaa108. PMID 32140727
- DERIVEDGonzalez F, Considine RV, Abdelhadi OA, Acton AJ. Saturated Fat Ingestion Promotes Lipopolysaccharide-Mediated Inflammation and Insulin Resistance in Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2019 Mar 1;104(3):934-946. doi: 10.1210/jc.2018-01143. PMID 30590569