Predictors of noncompliance in an oral contraceptive clinical trial

This analysis was conducted to identify the participant characteristics associated with noncompliance in an oral contraceptive (OC) clinical trial. We studied ovarian suppression among normal-weight and obese women during the use of levonorgestrel (LNG)-containing combination OCs. Participants under...

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Vydáno v:Contraception (Stoneham) Ročník 85; číslo 5; s. 465 - 469
Hlavní autoři: Westhoff, Carolyn L., Torgal, Anupama T., Mayeda, Elizabeth R., Shimoni, Noa'a, Stanczyk, Frank Z., Pike, Malcolm C.
Médium: Journal Article
Jazyk:angličtina
Vydáno: New York, NY Elsevier Inc 01.05.2012
Elsevier
Témata:
Adolescent
Adult
Biological and medical sciences
Biomarkers - blood
Clinical trial
Contraceptives, Oral, Combined - administration & dosage
Contraceptives, Oral, Combined - pharmacology
Dose-Response Relationship, Drug
Educational Status
Ethinyl Estradiol - administration & dosage
Ethinyl Estradiol - pharmacology
Female
Genital system. Reproduction
Gynecology. Andrology. Obstetrics
Hispanic Americans
Humans
Levonorgestrel - administration & dosage
Levonorgestrel - blood
Levonorgestrel - pharmacology
Medical sciences
Medication Adherence - ethnology
Noncompliance
Obesity - blood
Obesity - economics
Obesity - ethnology
Obstetrics and Gynecology
Oral contraceptives
Ovarian Follicle - drug effects
Ovulation Inhibition - drug effects
Patient Dropouts
Pharmacology. Drug treatments
Poverty
Single-Blind Method
United States
Young Adult
United States
USA
Oral contraceptives
Clinical trial
Noncompliance
Human
Compliance
Oral administration
Contraceptive
Predictive factor
ISSN:0010-7824, 1879-0518, 1879-0518
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Shrnutí:This analysis was conducted to identify the participant characteristics associated with noncompliance in an oral contraceptive (OC) clinical trial. We studied ovarian suppression among normal-weight and obese women during the use of levonorgestrel (LNG)-containing combination OCs. Participants underwent twice weekly phlebotomy during the study cycle and received up to $360 for participation. Along with other study assays, we analyzed 903 specimens from 181 women to measure LNG to assess OC compliance. Consistently undetectable LNG levels indicated noncompliance. To evaluate predictors of OC noncompliance during this study, we compared the characteristics of compliant and noncompliant participants using multivariable logistic regression. We assigned each participant to a relative poverty level based on US census data; all other individual characteristics came directly from participant responses during the baseline interview. One hundred eighty-one women completed the study; 31 were noncompliant (17%). In multivariable analyses, poverty level was the strongest predictor of noncompliance. Compared with those women in the quartile with the lowest level of residential poverty, other women were far more likely to be noncompliant, especially women in the quartile with the greatest prevalence of poverty (adjusted odds ratio, 8.4; 95% confidence interval, 1.5–46.1). Additional factors associated with noncompliance were education level less than a bachelor's degree and Hispanic ethnicity. Other demographic and psychometric measures were not associated with compliance. We found that noncompliance was strongly associated with residential poverty level, an indirect measure of individual income. In the United States, poverty is associated with female obesity, Hispanic ethnicity and low education, which were also associated here with noncompliance. Study compensation may motivate poor individuals to participate in clinical trials for income. Noncompliance in clinical trials, particularly differential noncompliance, jeopardizes study validity.
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ISSN:0010-7824
1879-0518
1879-0518
DOI:10.1016/j.contraception.2011.09.019