Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000991415
Ethics application status
Approved
Date submitted
21/08/2025
Date registered
8/09/2025
Date last updated
8/09/2025
Date data sharing statement initially provided
8/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of the menstrual cycle on low dose psilocybin
Scientific title
An open-label trial to test menstrual cycle effects and tolerance to low dose psilocybin in healthy menstruating persons (PsiMen).
Secondary ID [1] 315202 0
None
Universal Trial Number (UTN)
U1111-1322-7473
Trial acronym
PsiMen
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menstrual cycle 338647 0
Condition category
Condition code
Reproductive Health and Childbirth 334942 334942 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral psilocybin capsules.

5 mg psilocybin capsules taken orally. Adherence is through supervised administration. One dose administered in each of the ovulatory and luteal phases and three doses administered on consecutive days in the follicular phase.

Follicular visits are timed to the onset of last menses (5-9 days after)
Ovulatory visits are timed from ovulation measured through home ovulation testing (day or day after a positive test)
Luteal visits are timed 10-14 days after ovulation

Sessions will be collected from one menstrual cycle (ideally) but a further two menstrual cycles can be used in the case of missed visits.
Intervention code [1] 331818 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342573 0
Psychoactive drug effects
Timepoint [1] 342573 0
Collected at Baseline, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7 hours post-administration on each dosing day
Secondary outcome [1] 451345 0
Drug concentration
Timepoint [1] 451345 0
Blood samples will be taken at Baseline, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6,7 hours post-administration on each dosing day
Secondary outcome [2] 451346 0
Vital signs
Timepoint [2] 451346 0
Taken at Baseline, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6,7 hours post-administration on each dosing day

Eligibility
Key inclusion criteria
1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Aged, 18-46 years.
4. For heterosexually active persons of child-bearing potential: agree to use non-hormonal contraception.
5. To have regular menstrual cycles
Minimum age
18 Years
Maximum age
46 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Inability to adequately communicate in English (both written and spoken).
2. Any item 1-13 of the Premenstrual Symptoms Screening Tool scoring above “mild” and any item A-E scoring above mild.
3. Any current psychiatric diagnosis
4. Confirmed diagnosis of (or first degree relative with) schizophrenia or other psychotic disorder, or bipolar I or II disorder.
5. Risk of suicide as determined by The Columbia-Suicide Severity Rating Scale (C-SSRS).
6. Substance dependence in the previous 6 months as assessed by clinical interview with a New Zealand modified version of the NIDA (National Institute of Drug Abuse) Modified Alcohol, Smoking and Substance. Involvement Screening Test (NM-ASSIST).
7. Problematic use of alcohol defined as a score on the Alcohol Use Disorders Identification Test (AUDIT) of 16 or greater.
8. Body Mass Index (BMI) 35.
9. Planned or current pregnancy or lactation.
10. Cardiovascular conditions including abnormal heart rate or blood pressure to be checked at screening. A threshold of exceeding 160 mmHg (systolic) and 90 mmHg (diastolic), averaged across three assessments taken on the screening day will be used. Participants with well-managed hypertension would not be excluded.
11. Significant renal or hepatic impairment.
12. Diagnosed or probable polycystic ovary syndrome (PCOS)
13. Clinically relevant abnormal 12-lead electrocardiogram as judged by a study physician.
14. Clinically relevant abnormal laboratory test findings as judged by a study physician.
15. Any unstable medical or neurological condition.
16. Regular use of any Central Nervous System active medications in the last three months
17. Use of hormonal contraceptives/steroid hormones in the last three months
18. Regular use of any medication/supplements deemed to be contraindicating as judged by a study physician.
19. Treatment with another investigational drug /intervention within the last 3 months.
20. Use of serotonergic psychedelic drugs in the last 3 months.
21. Any other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/09/2025
Actual
Date of last participant enrolment
Anticipated
7/08/2026
Actual
Date of last data collection
Anticipated
8/12/2026
Actual
Sample size
Target
21
Accrual to date
Final
Recruitment outside Australia
Country [1] 27311 0
New Zealand
State/province [1] 27311 0

Funding & Sponsors
Funding source category [1] 319772 0
Charities/Societies/Foundations
Name [1] 319772 0
Auckland Medical Research Foundation
Country [1] 319772 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 322279 0
None
Name [1] 322279 0
Address [1] 322279 0
Country [1] 322279 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318330 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 318330 0
Ethics committee country [1] 318330 0
New Zealand
Date submitted for ethics approval [1] 318330 0
29/05/2025
Approval date [1] 318330 0
28/07/2025
Ethics approval number [1] 318330 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 143830 0
Prof Suresh Muthukumaraswamy
Address 143830 0
Faculty of Medical and Health Sciences, The University of Auckland. 85 Park Rd, Grafton, Auckland, 1023
Country 143830 0
New Zealand
Phone 143830 0
+64 09 9232787
Fax 143830 0
Email 143830 0
[email protected]
Contact person for public queries
Name 143831 0
Suresh Muthukumaraswamy
Address 143831 0
Faculty of Medical and Health Sciences, The University of Auckland. 85 Park Rd, Grafton, Auckland, 1023
Country 143831 0
New Zealand
Phone 143831 0
+64 09 9232787
Fax 143831 0
Email 143831 0
[email protected]
Contact person for scientific queries
Name 143832 0
Suresh Muthukumaraswamy
Address 143832 0
Faculty of Medical and Health Sciences, The University of Auckland. 85 Park Rd, Grafton, Auckland, 1023
Country 143832 0
New Zealand
Phone 143832 0
+64 09 9232787
Fax 143832 0
Email 143832 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Confidentiality



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.