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Diabetes drug trial criteria often exclude women of childbearing potential
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Exclusion of young women from clinical trials of type 2 diabetes medications is often disproportionate to risks posed to the woman or fetus, according to recent findings.
Fertility-related criteria may affect clinical knowledge critical for improving care of women with diabetes, the researchers wrote.
Richard S. Legro, MD, vice chair of research and professor of obstetrics and gynecology and public health sciences at Penn State College of Medicine, and colleagues evaluated 688 phase 2 and 3 trials in the United States registered with ClinicalTrials.gov that enrolled women aged 18 to 40 years. Researchers sought to determine the prevalence of fertility-related exclusion criteria in clinical trials of type 2 diabetes medications.
Richard S. Legro
Trials were grouped by category of drug administered, including category B (no risk to fetus in animal studies), category C (evidence of risks in animal models, without risk in humans in well-controlled trials), category D (known risks in human studies) and category X (significant risks outweighing benefits of use in pregnancy).
Of the studies, 58.4% indicated at least one fertility-related exclusion criterion; of these, 7.4% excluded all women of childbearing potential and 54.9% excluded current pregnancies. Six percent of studies required contraceptives after the end of the trial, 2.7% excluded women planning to donate ova and 2.8% required two contraceptives.
Trials using category C drugs were less likely to exclude current pregnancy (P = .0005) or require contraceptive use (P = .001) compared with category B drugs. At least one fertility-related criterion (P = .04), exclusion of women of childbearing potential (P = .02) and requirement of two contraceptives (P = .04) were more likely in trials using category X drugs compared with category B drugs. Trials with at least one unknown category drug were more likely to exclude all women of childbearing potential (P = .002) but less likely to require contraceptive use (P = .001) compared with category B drugs.
“The exclusion of women of childbearing potential from clinical trials, either outright or through multiple restrictive criteria, may be detrimental to clinical practice,” the researchers wrote. “Limiting participation of young women decreases study generalizability, as the risk to young women and fetuses who will eventually receive treatments is largely unknown. ... Examination of exclusion criteria from other common disorders affecting women of reproductive age, such as hypertension or mood disorders, may shed further light on these practices.” – by Amber Cox
Disclosure: Legro reports various financial ties with AstraZeneca, Bayer, Clarus, Ferring, KinDex, Sprout and Takeda.
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