A Study of the Effect of Estrogen-Based Contraceptive Therapy on Total and Free Serum Cortisol Levels in Healthy Women
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-001390
Sponsor Protocol Number: 15-001390
About this study
The purpose of this study is to determine the effect of estrogen-based contraceptive therapy on baseline and peak total and free cortisol levels in healthy women undergoing the Cosyntropin stimulation test.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Normal menstrual cycle prior to OCP initiation
- Perceived and documented state of good health
- Ability and desire to undergo Cosyntropin stimulation testing at baseline and at least 6 weeks after initiation or discontinuation of OCP therapy
Exclusion Criteria
- Contraindication or sensitivity to Cosyntropin
- Poorly controlled diabetes mellitus defined as HbA1c >7.5%,
- Use of exogenous glucocorticoid medication or Megace within the last 12 months
- Adrenal insufficiency
- Current glucocorticoid use
- Liver disease
- Chronic renal insufficiency
- Hyperthyroidism
- Anorexia nervosa
- Current inflammatory state
- Active malignancy
- Pregnancy
- BMI <18 or >40 kg/m2
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Irina Bancos, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available