Premenstrual Hormonal and Affective State Evaluation (PHASE) Project

NCT03862469 | Completed Results

• 2 other identifiers: 2018-1533R21MH119642
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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).

Conditions

Premenstrual Dysphoric Disorder

Outcome Measures

Primary Outcomes (1)

• Hormone Analysis

  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)

Study Arms (1)

All Participants

OTHER

Procedure: Individualized laboratory test

Interventions

Individualized laboratory test PROCEDURE

Laboratory test administered between 6 and 2 days prior to the subsequent menstrual cycle.

All Participants

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Department of Pharmacy Practice

Chicago, Illinois, 60612, United States

Location

Related Publications (25)

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  PMID: 28229114 BACKGROUND

• American College of Obstetricians and Gynecologists. Premenstrual Syndrome. ACOG Practice Bulletin No. 15. Washington, DC: American College of Obstetricians and Gynecologists, 2000.

  BACKGROUND

• 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.

  PMID: 6686333 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 11681764 BACKGROUND

• 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.

  PMID: 19373620 BACKGROUND

• 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.

  PMID: 29260367 BACKGROUND

• 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.

  PMID: 16172836 BACKGROUND

• 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.

  PMID: 28273494 BACKGROUND

• 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.

  PMID: 20176450 BACKGROUND

• 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.

  PMID: 18974081 BACKGROUND

• 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.

  PMID: 8255414 BACKGROUND

• 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.

  PMID: 16651505 BACKGROUND

• 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.

  PMID: 21035130 BACKGROUND

• 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.

  PMID: 22450372 BACKGROUND

• 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.

  PMID: 22029804 BACKGROUND

• 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.

  PMID: 22377229 BACKGROUND

• 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.

  PMID: 16650465 BACKGROUND

• 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.

  PMID: 9435325 BACKGROUND

• 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.

  PMID: 29180346 BACKGROUND

• 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.

  PMID: 18644678 BACKGROUND

• 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.

  PMID: 20053272 BACKGROUND

• 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.

  PMID: 23277355 BACKGROUND

• 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.

  PMID: 10940144 BACKGROUND

• 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.

  PMID: 29146473 BACKGROUND

MeSH Terms

Conditions

Premenstrual Dysphoric Disorder

Condition Hierarchy (Ancestors)

Premenstrual Syndrome; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Ajna Hamidovic
• Organization: University of Illinois at Chicago

ahamidov@uic.edu

312-355-1713

Study Officials

• Ajna Hamidovic, PharmD, MS

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 5, 2019
• Study Start: September 26, 2019
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: April 24, 2025
• Results First Posted: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)