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Clinical Trials/ACTRN12621001269820
ACTRN12621001269820Not yet recruiting未知

(S)-S-adenosylmethionine (SAMe) in the treatment of pre-menstrual spectrum disorders in adult women: An open-label pilot study

Alfred Health0 sites30 target enrollmentStarted: September 20, 2021Last updated:
Conditions

Trial Snapshot

Phase
未知
Status
Not yet recruiting
Enrollment
30

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Non-randomised trial
Primary Purpose
Treatment
Masking
Open (masking not used)

Eligibility Criteria

Ages
18 Years to 45 Years (—)
Sex
Female

Inclusion Criteria

  • 1. Women aged between 18-45 with regular menstrual cycles (regular onset, duration and cycle).
  • 2. Fulfill the diagnostic criteria for a premenstrual spectrum disorder, either PMS or PMDD as per the Diagnostic and Statistical Manual Version Five (DSM-V) criteria as screened during recruitment.
  • 3. Proficient in both reading and writing in English.
  • 4. Stabilise in current psychotherapy, if applicable, for at least eight weeks prior to study commencement.

Exclusion Criteria

  • 1. Pregnant or lactating women.
  • 2. Women less than one-year post-partum.
  • 2. Women with irregular menstrual cycles, including perimenopausal and menopausal women and women diagnosed with polycystic ovarian syndrome.
  • 3. Taking hormone replacement therapy and hormonally based contraceptives, including the Combined Oral Contraceptive Pill (COCP), etonogestrel implant (Implanon), intrauterine levonogestral devices (Mirena), transdermal oestradiol patches or depot progesterone injections.
  • 4. Taking psychotropic medications such as serotonergic agents, monoamine oxidase inhibitors or other forms of antidepressants, including atypical antidepressants such as agomelatine.
  • 5. Clinically significant renal or hepatic impairment, haematological, oncological or cardiovascular disease.
  • 6. Consumption of alcohol beyond the National Health and Medical Research Council (NHMRC) guidelines for safer alcohol use. That is, no more than 10 standard drinks a week and no more than four standard drinks in any single occasion.
  • 7. Substance misuse or dependence requiring intervention or rehabilitation in the last three months.
  • 8. Woman taking other complimentary alternative medicines, including cannabinoid containing agents such as cannabidiol (CBD) products.

Investigators

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