Transl Clin Pharmacol.  2019 Dec;27(4):127-133. 10.12793/tcp.2019.27.4.127.

The problem of medicating women like the men: conceptual discussion of menstrual cycle-dependent psychopharmacology

• Yum SK
• Yum SY
• Kim T

• KMID: 2467966
• DOI: http://doi.org/10.12793/tcp.2019.27.4.127

Abstract

While hormonal changes during the ovulatory cycles affect multiple body systems, medical management, including medication dosing remains largely uniform between the sexes. Little is known about sex-specific pharmacology in women. Although hormonal fluctuations of the normal menstruating process alters women's physiology and brain biochemistry, medication dosing does not consider such cyclical changes. Using schizophrenia as an example, this paper illustrates how a woman's clinical symptoms can change throughout the ovulatory cycle, leading to fluctuations in medication responses. Effects of sex steroids on the brain, clinical pharmacology are discussed. Effective medication dose may be different at different phases of the menstrual cycle. Further research is needed to better understand optimal treatment strategies in reproductive women; we present a potential clinical trial design for examining optimal medication dosing strategies for conditions that have menstruation related clinical fluctuations.

Keyword

Clinical trial design; Drug dose; Menstrual cycle; Schizophrenia; Sex steroids

MeSH Terms

Biochemistry
Brain
Clothing
Female
Humans
Male
Menstrual Cycle
Menstruation
Pharmacology
Pharmacology, Clinical
Physiology
Psychopharmacology*
Schizophrenia
Steroids
Steroids

Figure

• 

  Figure 1 Patient's records of sleep and subjective moods, and clinician-observed of psychopathology in an ovulatory cycle. Cycle day 1 = first day of the period. The median values for each cycle day over 9 cycles (254 days) prior to sustained clinical stability are represented, including the period of clinician-only ratings prior to beginning the patient's 123 days of self-monitoring. (A) hours of sleep, (B) patient-rated moods (1–10: 1 = lowest ever, 10 = highest ever, 5 = usual in the past year), (C) PANSS factor scores: (C-1) positive psychotic symptoms, (C-2) paranoid/ belligerence, (C-3) thought disturbance, (D) relationship between hours of sleep and self-rated mood.

• 

  Figure 2 The first phase of the study will prospectively assess symptom changes throughout the menstrual cycles on continuous fixed-dose treatment. For patients who have less than 2 of 3 symptomatic cycles, the trial ends after the lead-in phase. Those with at least 2 of 3 symptomatic cycles will progress to the second phase of the trial. All patients will continue to receive the standard fixed-dose. Patients are randomized to receive an additional dose premenstrually of either medication or dummy. The patients are crossed-over to the other group multiple times.

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