Women were less than half of the people tested for almost all of these common medicines.
PregnancyCommunity forum

NCT01523002

Drug Interaction Study of Pyronaridine-artesunate & Metoprolol, & Redosing Study of Pyronaridine-artesunate

See it on ClinicalTrials.gov ↗

56 people

27 womenmiddle line = equal numbers29 men
Phase
PHASE1
Paid for by
Medicines for Malaria Venture
Finished
2012-10
Health conditions
Malaria
Who could join
Anyone
Ages
18 Years – 55 Years
Average age
mean 43 years
Age 65+
Not reported
Weight (BMI)
mean 24.6 kg/m^2
Pregnancy recorded
Not reported
Menopause recorded
Not reported
Results shown by sex
Not split by sex
Race
White 96.4% · Black / African American 1.8% · Asian 1.8%

Women left out

  • Age limit under 65

    Older women were turned away, even though they often take this medicine.

    “Maximum age: 55 Years.”
  • No pregnant women

    Women who were pregnant could not join.

    “Female subjects of childbearing potential with a negative urine pregnancy test at screening confirmed at Day -1 by a serum pregnancy test and who agreed to one of the following methods:”
  • Had to use birth control

    Women who couldn't or didn't want to use birth control were turned away.

    “Double barrier method of contraception for 2 weeks before first study drug administration and throughout the entire study follow up period”
  • Only women past menopause

    Women who could still get pregnant were turned away.

    “…f non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who was post-menopausal (i.e. one year without menses) or who has undergone sterilization (via hysterectomy or bilateral tubal ligation)”
  • Weight limit (BMI)

    Women with a higher (or lower) body weight were turned away.

    “Male or female subjects between the ages of 18 and 55 years with a body weight between 50 and 90 kg and a body mass index calculated using Quetelet's Index - weight (kg)/height2 (m2) between 18.5-30.0”
  • No heart disease

    Women with heart disease, heart rhythm problems or a past heart attack were turned away.

    “…evidence of clinically significant disorders such as cardiovascular (including arrhythmia, acute corrected QT interval greater or equal to 450 milliseconds), respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, im…”
  • No mental health conditions

    Women with depression, bipolar disorder or other mental health conditions were turned away.

    “…ory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other abnormality (including head trauma)”
  • No cancer

    Women with current or past cancer were turned away.

    “…ory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other abnormality (including head trauma)”
  • No smokers

    Women who smoke or use nicotine were turned away.

    “Presence or recent history (last two years) of tobacco abuse (≥10 cigarettes/day)”

Study titles and rules are shown in their original English.