Clinical trial · Interventional
Cortisol Regulation in Polycystic Ovary Syndrome (PCOS)
Cortisol Regulation in Polycystic Ovary Syndrome
NCT00694759CI-TRIAL-00040472completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if insulin resistance (how well the body uses insulin and clears sugar) can affect cortisol levels in normal healthy women and women with polycystic ovary syndrome of all body weights.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| metformin | Drug | Metformin | ALIAS |
| pioglitazone | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Pioglitazone will be given to women with PCOS. After one month and six months of therapy, measure (a) 24-hour CPR, ACTH, free cortisol, and CBG, (b) adipocyte, liver, and whole body HSD 1 activity, and (c) insulin sensitivity, visceral fat, and androgen levels.
- interventionNames
- Drug: pioglitazone
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- Metformin will be given to women with PCOS. After one month and six months of therapy, measure (a) 24-hour CPR, ACTH, free cortisol, and CBG, (b) adipocyte, liver, and whole body HSD 1 activity, and (c) insulin sensitivity, visceral fat, and androgen levels.
- interventionNames
- Drug: metformin
- type
- PLACEBO_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria (Healthy controls): * Healthy * At lifetime maximal weight * Weight stable for at least 6 months prior to study entry * Willing to commit to not making significant changes to their diet or daily activities while enrolled. * Premenopausal * Have regular menstrual cycles * No evidence of hirsutism Additional Inclusion Criteria (Subjects with PCOS): * Clinical findings of amenorrhea or oligomenorrhea dating from menarche * Clinical and/or biochemical evidence of hyperandrogenism * Exclusion of related disorders Exclusion Criteria (Healthy controls): * Less than 18 years of age * Exercise \> 30 minutes/day, 3 times a week * Smokers * Heavy alcohol drinkers (\> 2 drinks/day) * Type 2 diabetes * Medical diagnoses including heart disease and cancer * Psychiatric illness (i.e.depression, psychosis, bipolar, schizophrenia) * Body weight \> 136 kg * Pregnant * Endocrine diseases affecting body composition or androgen levels Additional Exclusion Criteria (Subjects with PCOS): * Laboratory evidence of hyperprolactinemia, thyroid dysfunction, or 21-hydroxylase-deficient nonclassic CAH * Contraindication to pioglitazone (i.e. CHF, impaired liver function, anemia, depressed leukocyte counts, pulmonary disease, known sensitivity to thiazolidinediones.
References
Publications (0)
Data not yet available
No reference posted for this study.