NCT03862469

Premenstrual Hormonal and Affective State Evaluation (PHASE) Project

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

PHASE is designed to evaluate neuroactive hormone trajectories across the menstrual cycle and endocrine, autonomic, and subjective responses to psychosocial stress in women suffering from severe PMS (i.e., premenstrual dysphoric disorder).

Detailed description

Female 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 and ovulation. Study participants will continue to perform ovulation testing during their third menstrual cycle in which they will attend one individualized task session and provide 8 serum samples at different timepoints across the menstrual cycle. Primary analyses will contrast neuroactive hormone trajectories across the menstrual cycle and stress reactivity according to study groups (PMDD vs healthy).

Conditions

• Premenstrual Dysphoric Disorder

Interventions

Type	Name	Description
PROCEDURE	Individualized laboratory test	Laboratory test administered between 6 and 2 days prior to the subsequent menstrual cycle.

Timeline

• Start date: 2019-09-26
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2019-03-05
• Last updated: 2025-04-24
• Results posted: 2025-04-24

Locations

1 site across 1 country: United States