Premenstrual Syndrome Etiology Pilot Study
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 3/10/2019 |
| Start Date: | March 1, 2019 |
| End Date: | March 1, 2021 |
| Contact: | Ajna Hamidovic, PharmD, MS |
| Email: | ahamidov@uic.edu |
| Phone: | 312-355-1713 |
PMSe is designed to evaluate reproductive and HPA axis hormone levels over the course of the
menstrual cycle in women with Premenstrual Syndrome. Study objectives are to preliminarily
show efficient kinetic modeling and absence of participant burden interfering with
participant retention.
menstrual cycle in women with Premenstrual Syndrome. Study objectives are to preliminarily
show efficient kinetic modeling and absence of participant burden interfering with
participant retention.
Healthy volunteers will be recruited from the community for participation in this 3-menstrual
cycle study. In the first two menstrual cycles, study participants will chart their symptoms
and use Easy@Home Ovulation strip to chart their ovulation using the PreMom app. This period
will separate study participants into two groups: those with vs. without the PMS diagnosis.
Study participants will continue to perform ovulation testing during their third menstrual
cycle. They will provide 8 serum samples at specific ovulation-guided menstrual cycle times.
cycle study. In the first two menstrual cycles, study participants will chart their symptoms
and use Easy@Home Ovulation strip to chart their ovulation using the PreMom app. This period
will separate study participants into two groups: those with vs. without the PMS diagnosis.
Study participants will continue to perform ovulation testing during their third menstrual
cycle. They will provide 8 serum samples at specific ovulation-guided menstrual cycle times.
Inclusion Criteria:
- Female
- Aged 18-35 years, established by visual inspection of a government-issued ID
- Average menstrual cycle 21-35 days
- Access to smartphone with working camera for daily use of the PreMom application
Exclusion Criteria:
- Lifetime DSM-5 Axis 1 disorder (except anxiety and depression), as documented in the
Mental Health Interview
- Current DSM-5 Axis depressive or anxiety disorder, as documented in the Mental Health
Interview
- Positive urine drug screen test
- Breath alcohol concentration >0.00%
- Self-reported smoker or carbon monoxide concentration ≥ 6 ppm
- Irregular menstrual cycle
- Current pregnancy (urine test-verified) or lactation, or a plan to become pregnant
- Moderate or high suicide risk
- Shipley IQ (vocabulary standard score) > 80
- Prescription medications
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