A Study to Evaluate Blood Chemistry, Genetics, and Eye Exams in Women with Polycystic Ovary Syndrome and/or Idiopathic Intracranial Hypertension
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: 16-004958
Sponsor Protocol Number: 16-004958
About this study
The purpose of this study is to evaluate the blood chemistry, genetics, and eye exams in women with polycystic ovary syndrome and/or intracranial hypertension. Similar studies are being completed with astronauts. The results may help us better understand the nature, and ultimately the treatment of polycystic ovary syndrome, intracranial hypertension, and astronaut eye and vision issues.
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:
- Male and female adults; premenopausal women.
- Age 18 – 50 years.
- Due to rare presentation of IIH, we will also include men with IIH and women older than 50 for genetic data and to compare to astronaut data.
- PCOS: PCOS criteria of both oligomenorrhea (<9 menses per year) and androgen excess [clinical hirsutism (Ferriman-Gallway score >8 or severe acne) or elevated testosterone]. Prior use of any medications for the treatment of PCOS should have been discontinued at least three months prior to participation. Participants that have >9 menses per year who meet other PCOS criteria will be given option of having progesterone test drawn between days 20 and 22 of menstrual cycle to confirm anovulatory status.
- IIH: Patients will be classified as having IIH if they meet the Modified Dandy criteria, which includes signs and symptoms of increased intracranial pressure, no localizing neurologic finding except CN VI palsies, normal neuroimaging, lumbar puncture opening pressure >250 mm Hg with normal CSF, and no other cause present. Patients presenting with papilledema and borderline opening pressures (200-250 mm Hg) will also be classified as having IIH.
- Control subjects will be matched for age and BMI, and will not have PCOS or IIH, as defined by criteria above.
Exclusion Criteria:
- Diagnosis of Cushing’s syndrome.
- Untreated hypo/hyperthyroidism.
- Elevated prolactin.
- Congenital adrenal hyperplasia.
- Renal insufficiency (creatinine > 1.5).
- Diabetes.
- No medications that can affect androgen concentrations or insulin sensitivity.
- Patients cannot be pregnant, breast-feeding, or taking oral contraceptives.
- Participants cannot be on medications that affect folate or B12 metabolism, such as:
- Methotrexate;
- Trimethoprim;
- Triamterene;
- Phenobarbital;
- Phenytoin;
- Carbamazepine;
- Gabapentin;
- Primidone.
- In the interest of promoting recruitment for individuals diagnosed with the rare condition of IIH, IIH patients receiving topiramate treatment or any treatment for PCOS will not be excluded from participation in the study.
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 Alice Chang, M.D., M.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available