Premenstrual Hormonal and Affective State Evaluation (PHASE) Project (PHASE Project)

April 4, 2025 updated by: Ajna Hamidovic, PharmD, MS, University of Illinois at Chicago
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois Department of Pharmacy Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 31 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female
  • Aged 18-35 years, established by visual inspection of a government-issued ID
  • Average menstrual cycle 21-35 days

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
  • Any prescription medications (including hormonal forms of birth control)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: All Participants
Procedure: Individualized laboratory test
Laboratory test administered between 6 and 2 days prior to the subsequent menstrual cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hormone Analysis
Time Frame: -20, +20, +30, +40, +50, +65, +90 minutes in the late luteal phase of the menstrual cycle (one day between -1 to -6 days of the subsequent menstrual cycle)
Cortisol
-20, +20, +30, +40, +50, +65, +90 minutes in the late luteal phase of the menstrual cycle (one day between -1 to -6 days of the subsequent menstrual cycle)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Investigators

  • Principal Investigator: Ajna Hamidovic, PharmD, MS, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2019

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

February 27, 2019

First Submitted That Met QC Criteria

March 1, 2019

First Posted (Actual)

March 5, 2019

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-1533
  • R21MH119642 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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