A Study of the Effect of Estrogen-Based Contraceptive Therapy on Total and Free Serum Cortisol Levels in Healthy Women

Overview

  • Study type

    Observational
  • Study IDs

  • Describes 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.
  • 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. If you need assistance understanding the eligibility criteria, please contact the study team.

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 us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Irina Bancos, M.D.

Closed for enrollment

Contact information:

Sina Jasim M.D.

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20304382

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