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

NCT01552915

Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder

See it on ClinicalTrials.gov ↗

459 people

154 womenmiddle line = equal numbers305 men
Phase
PHASE4
Paid for by
Shire
Finished
2014-01-22
Health conditions
Attention-deficit/Hyperactivity Disorder
Who could join
Anyone
Ages
13 Years – 17 Years
Average age
mean 14.7 Years
Age 65+
0%
Weight (BMI)
Not reported
Pregnancy recorded
Not reported
Menopause recorded
Not reported
Results shown by sex
Not split by sex
Race
Not reported

Women left out

  • Age limit under 65

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

    “Maximum age: 17 Years.”
  • No pregnant women

    Women who were pregnant could not join.

    “Subject is female and is pregnant or lactating.”
  • No breastfeeding moms

    Women who were breastfeeding could not join.

    “Subject is female and is pregnant or lactating.”
  • Had to use birth control

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

    “Subject, who is a female, must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test and a negative urine pregnancy test and agree to comply with any applicable contraceptive requirements of the protocol.”
  • No heart disease

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

    “Subject has a known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems tha…”
  • No seizures

    Women with epilepsy or past seizures were turned away.

    “Subject has a history of seizures (other than infantile febrile seizures), a chronic or current tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.”
  • No mental health conditions

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

    “…ontrolled (with medications prohibited in this study) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any significant comorbid Axis II disorder or significant Axis I disorder (such as post traumatic stress…”
  • No smokers

    Women who smoke or use nicotine were turned away.

    “Subject has a history of suspected substance abuse or dependence disorder (excluding nicotine). Subjects with a lifetime history of amphetamine, cocaine, or other stimulant abuse and/or dependence will be excluded.”

Study titles and rules are shown in their original English.