Multiple Sclerosis: Symptoms and Hormones Study
- Study HIC#:2000029078
- Last Updated:11/11/2022
If you are a woman who is 18 to 45 years old with a prior diagnosis of multiple sclerosis (MS), are on some form of contraception, and not planning on becoming pregnant in the upcoming year, you may be eligible to participate in a free and confidential study that will look at how hormonal levels alter the symptoms of MS. The study involves filling out weekly questionnaires for 6 months and tracking symptoms using a fitness app. Reimbursement up to $50.
To learn more or see if you are eligible to participate, please contact us at MSResearch@yale.edu
- Age18 years - 45 years
- GenderFemale only
- Start Date04/13/2021
- End Date11/30/2022
To be eligible for inclusion in the study, an individual must meet all of the following criteria:
● Aged 18-45
● MS/CIS diagnosis by 2017 McDonald Criteria
● Not planning pregnancy during the study
● No change in disease modifying therapy (DMT) (except for switching from Rituximab to Ocrelizumab) for at least 6 months
● No relapses or new inflammatory lesions or steroid use (other than in the setting of
infusions) in prior 3 months
● Same form of contraceptive for at least 3 months prior to enrollment. Contraception categories include:
- Grp I. Non-medicated/mechanical contraception users: condom, spermicide, copper intrauterine device
- Grp II. IUD (Mirena) users
- Grp III. Cyclical contraceptive users
- Grp IV. Continuous contraceptive users
Individuals utilizing forms of birth control not listed above (subcutaneous hormonal [Implanon, Nexplanon], tubal ligation, injectable progesterones (Depo-Provera) will not be eligible for participation in the study.
Abnormal menstrual cycles if women not on study OC (Grps II-IV), based on:
o Study significant:
- Flow <2 or >7 days (except when using IUD or OC)
- Cycle <21 or >35 days
o Clinically significant: amenorrhea lasting three months or more and oligomenorrhea (fewer than nine menstrual cycles per year or cycle length greater than 35 days)
● Secondary amenorrhea based on: absence of menses for more than three months in girls or women who previously had regular menstrual cycles or six months in girls or women who had irregular menses
Etiologies may include chromosomal or developmental causes; secondary dys/amenorrhea due to endometrial (Asherman’s, ablation, uterine/cervical cancer),pituitary, PCOS, or hypothalamic (anorexia, excessive exercise) conditions; ovarian cancer; uncorrected thyroid condition
Use of systemic steroid medications including glucocorticoids, androgens, estrogens or progestogens other than the study contraceptives within 3M of study entry.
● Pregnant women
- Other autoimmune
- Non-MS pain (fibromyalgia, etc): pain that is not caused by any of the following: continuous central neuropathic pain (e.g. dysesthetic extremity pain), intermittent central neuropathic pain (e.g. trigeminal neuralgia, Lhermitte’s sign), muscle or tonic spasms, or any pain caused by aberrant ephaptic (nonsynaptic) transmission from somatosensory to nociceptive fibres at a site of local damage to the myelin sheath.
- Severe depression (PHQ9> 15; suicidal ideation per PHQ9 or clinician evaluation; other significant uncontrolled psychiatric disorder (schizophrenia, known Axis II) that in clinician’s opinion would interfere with ability to participate in study.