search
Back to results

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

Primary Purpose

Premenstrual Dysphoric Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Individualized laboratory test
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premenstrual Dysphoric Disorder

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Illinois Department of Pharmacy PracticeRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study Procedure (all participants)

Arm Description

Diagnostic Phase (2 months): at-home urine hormone testing and completion of daily online surveys. Individualized Task (-6 to -2 days from the subsequent menstrual cycle)

Outcomes

Primary Outcome Measures

Hormone Analysis
Allopregnanolone, cortisol, progesterone
Cardiovascular function
Heart Rate, Heart Rate Variability
Affect
Subjective Mood States
Estradiol concentrations at 6 menstrual cycle sub-phases
Mean levels of estradiol

Secondary Outcome Measures

Full Information

First Posted
February 27, 2019
Last Updated
October 7, 2022
Sponsor
University of Illinois at Chicago
search

1. Study Identification

Unique Protocol Identification Number
NCT03862469
Brief Title
Premenstrual Hormonal and Affective State Evaluation (PHASE) Project
Acronym
PHASE Project
Official Title
Premenstrual Hormonal and Affective State Evaluation (PHASE) Project
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2019 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Dysphoric Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Procedure (all participants)
Arm Type
Other
Arm Description
Diagnostic Phase (2 months): at-home urine hormone testing and completion of daily online surveys. Individualized Task (-6 to -2 days from the subsequent menstrual cycle)
Intervention Type
Procedure
Intervention Name(s)
Individualized laboratory test
Intervention Description
Laboratory test administered between 6 and 2 days prior to the subsequent menstrual cycle.
Primary Outcome Measure Information:
Title
Hormone Analysis
Description
Allopregnanolone, cortisol, progesterone
Time Frame
2 hours
Title
Cardiovascular function
Description
Heart Rate, Heart Rate Variability
Time Frame
2 hours
Title
Affect
Description
Subjective Mood States
Time Frame
2 hours
Title
Estradiol concentrations at 6 menstrual cycle sub-phases
Description
Mean levels of estradiol
Time Frame
One menstrual cycle

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ajna Hamidovic, PharmD, MS
Phone
312-355-1713
Email
ahamidov@uic.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Fatimata Soumare
Phone
3129968838
Email
fsouma2@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ajna Hamidovic, PharmD, MS
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois Department of Pharmacy Practice
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ajna Hamidovic, PharmD
Phone
312-355-1713
Email
ahamidov@uic.edu
First Name & Middle Initial & Last Name & Degree
Yohyoh Wang
Phone
(312) 996-8838
Email
yohyoh@uic.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28229114
Citation
Allen AP, Kennedy PJ, Dockray S, Cryan JF, Dinan TG, Clarke G. The Trier Social Stress Test: Principles and practice. Neurobiol Stress. 2016 Nov 12;6:113-126. doi: 10.1016/j.ynstr.2016.11.001. eCollection 2017 Feb.
Results Reference
background
Citation
American College of Obstetricians and Gynecologists. Premenstrual Syndrome. ACOG Practice Bulletin No. 15. Washington, DC: American College of Obstetricians and Gynecologists, 2000.
Results Reference
background
PubMed Identifier
6686333
Citation
Backstrom T, Sanders D, Leask R, Davidson D, Warner P, Bancroft J. Mood, sexuality, hormones, and the menstrual cycle. II. Hormone levels and their relationship to the premenstrual syndrome. Psychosom Med. 1983 Dec;45(6):503-7. doi: 10.1097/00006842-198312000-00004.
Results Reference
background
Citation
Carlin, J. B., Galati, J. C., & Royston, P. (2008). A new framework for managing and analyzing multiply imputed data in Stata. Stata Journal, 8(1), 49-67.
Results Reference
background
PubMed Identifier
11681764
Citation
Critchlow DG, Bond AJ, Wingrove J. Mood disorder history and personality assessment in premenstrual dysphoric disorder. J Clin Psychiatry. 2001 Sep;62(9):688-93. doi: 10.4088/jcp.v62n0905.
Results Reference
background
PubMed Identifier
19373620
Citation
Cunningham J, Yonkers KA, O'Brien S, Eriksson E. Update on research and treatment of premenstrual dysphoric disorder. Harv Rev Psychiatry. 2009;17(2):120-37. doi: 10.1080/10673220902891836.
Results Reference
background
PubMed Identifier
29260367
Citation
Deng D, Pang Y, Duan G, Liu H, Liao H, Liu P, Liu Y, Li S, Chen W, Wen D, Xuan C, Li M. Larger volume and different functional connectivity of the amygdala in women with premenstrual syndrome. Eur Radiol. 2018 May;28(5):1900-1908. doi: 10.1007/s00330-017-5206-0. Epub 2017 Dec 19.
Results Reference
background
PubMed Identifier
16172836
Citation
Endicott J, Nee J, Harrison W. Daily Record of Severity of Problems (DRSP): reliability and validity. Arch Womens Ment Health. 2006 Jan;9(1):41-9. doi: 10.1007/s00737-005-0103-y. Epub 2005 Sep 20.
Results Reference
background
PubMed Identifier
28273494
Citation
Fischer S, Cleare AJ. Cortisol as a predictor of psychological therapy response in anxiety disorders-Systematic review and meta-analysis. J Anxiety Disord. 2017 Apr;47:60-68. doi: 10.1016/j.janxdis.2017.02.007. Epub 2017 Feb 24.
Results Reference
background
PubMed Identifier
20176450
Citation
Hamidovic A, Childs E, Conrad M, King A, de Wit H. Stress-induced changes in mood and cortisol release predict mood effects of amphetamine. Drug Alcohol Depend. 2010 Jun 1;109(1-3):175-80. doi: 10.1016/j.drugalcdep.2009.12.029. Epub 2010 Feb 21.
Results Reference
background
PubMed Identifier
18974081
Citation
Howards PP, Schisterman EF, Wactawski-Wende J, Reschke JE, Frazer AA, Hovey KM. Timing clinic visits to phases of the menstrual cycle by using a fertility monitor: the BioCycle Study. Am J Epidemiol. 2009 Jan 1;169(1):105-12. doi: 10.1093/aje/kwn287. Epub 2008 Oct 30.
Results Reference
background
PubMed Identifier
8255414
Citation
Kirschbaum C, Pirke KM, Hellhammer DH. The 'Trier Social Stress Test'--a tool for investigating psychobiological stress responses in a laboratory setting. Neuropsychobiology. 1993;28(1-2):76-81. doi: 10.1159/000119004.
Results Reference
background
PubMed Identifier
16651505
Citation
Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of pilot studies to guide power calculations for study proposals. Arch Gen Psychiatry. 2006 May;63(5):484-9. doi: 10.1001/archpsyc.63.5.484.
Results Reference
background
PubMed Identifier
21035130
Citation
Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626-9. doi: 10.1016/j.jpsychires.2010.10.008. Epub 2010 Oct 28.
Results Reference
background
PubMed Identifier
22450372
Citation
Lovick TA. Estrous cycle and stress: influence of progesterone on the female brain. Braz J Med Biol Res. 2012 Apr;45(4):314-20. doi: 10.1590/s0100-879x2012007500044. Epub 2012 Mar 29.
Results Reference
background
PubMed Identifier
22029804
Citation
Moore CG, Carter RE, Nietert PJ, Stewart PW. Recommendations for planning pilot studies in clinical and translational research. Clin Transl Sci. 2011 Oct;4(5):332-7. doi: 10.1111/j.1752-8062.2011.00347.x.
Results Reference
background
PubMed Identifier
22377229
Citation
Qiao M, Zhang H, Liu H, Luo S, Wang T, Zhang J, Ji L. Prevalence of premenstrual syndrome and premenstrual dysphoric disorder in a population-based sample in China. Eur J Obstet Gynecol Reprod Biol. 2012 May;162(1):83-6. doi: 10.1016/j.ejogrb.2012.01.017. Epub 2012 Feb 28.
Results Reference
background
PubMed Identifier
16650465
Citation
Rubinow DR, Schmidt PJ. Gonadal steroid regulation of mood: the lessons of premenstrual syndrome. Front Neuroendocrinol. 2006 Jul;27(2):210-6. doi: 10.1016/j.yfrne.2006.02.003. Epub 2006 May 2.
Results Reference
background
PubMed Identifier
9435325
Citation
Schmidt PJ, Nieman LK, Danaceau MA, Adams LF, Rubinow DR. Differential behavioral effects of gonadal steroids in women with and in those without premenstrual syndrome. N Engl J Med. 1998 Jan 22;338(4):209-16. doi: 10.1056/NEJM199801223380401.
Results Reference
background
PubMed Identifier
29180346
Citation
Sohda S, Suzuki K, Igari I. Relationship Between the Menstrual Cycle and Timing of Ovulation Revealed by New Protocols: Analysis of Data from a Self-Tracking Health App. J Med Internet Res. 2017 Nov 27;19(11):e391. doi: 10.2196/jmir.7468.
Results Reference
background
PubMed Identifier
18644678
Citation
Solis-Ortiz S, Corsi-Cabrera M. Sustained attention is favored by progesterone during early luteal phase and visuo-spatial memory by estrogens during ovulatory phase in young women. Psychoneuroendocrinology. 2008 Aug;33(7):989-98. doi: 10.1016/j.psyneuen.2008.04.003. Epub 2008 Jul 21.
Results Reference
background
PubMed Identifier
20053272
Citation
Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1. Erratum In: BMC Med Res Methodol. 2023 Mar 11;23(1):59.
Results Reference
background
PubMed Identifier
23277355
Citation
Toffol E, Heikinheimo O, Partonen T. Associations between psychological well-being, mental health, and hormone therapy in perimenopausal and postmenopausal women: results of two population-based studies. Menopause. 2013 Jun;20(6):667-76. doi: 10.1097/gme.0b013e318278eec1.
Results Reference
background
PubMed Identifier
10940144
Citation
Whooley MA, Grady D, Cauley JA. Postmenopausal estrogen therapy and depressive symptoms in older women. J Gen Intern Med. 2000 Aug;15(8):535-41. doi: 10.1046/j.1525-1497.2000.04029.x.
Results Reference
background
PubMed Identifier
29146473
Citation
Yen JY, Wang PW, Su CH, Liu TL, Long CY, Ko CH. Estrogen levels, emotion regulation, and emotional symptoms of women with premenstrual dysphoric disorder: The moderating effect of estrogen receptor 1alpha polymorphism. Prog Neuropsychopharmacol Biol Psychiatry. 2018 Mar 2;82:216-223. doi: 10.1016/j.pnpbp.2017.11.013. Epub 2017 Nov 14.
Results Reference
background

Learn more about this trial

Premenstrual Hormonal and Affective State Evaluation (PHASE) Project

We'll reach out to this number within 24 hrs