The Pharmacokinetics of Implanon in Obese Women

Summary: Prior studies examining the pharmacokinetics, safety, and efficacy of the new etonogestrel (ENG)-containing single rod implantable contraceptive device, Implanon, did not include women who exceeded 130% of ideal body weight. Yet, as these women comprise a significant portion of the U.S. population, studies of Implanon in obese women are essential. We aim to describe the pharmacokinetics (hormone levels) of Implanon in obese women during the first 6 months of use and to provide data on the acceptability, side effect profile, and ease of insertion, palpation, and removal in these women. Another aspect of the study involves developing new ways of testing hormone levels. Recently, accurate tests have been developed using samples called “blood spots”, which are drops of blood obtained through a finger-prick and dried on filter paper. We will collect blood spot samples for future analysis to see if this method can be used to accurately test blood ENG levels.
go to top of page

Principle Investigator(s):
Melissa Gilliam MD MPH
Sara Mornar DO
Co-Investigators:
Sabrina Holmquist MD MPH
Sigrid Tristan MD
Amy Whitaker MD MS

Acceptability of NuvaRing® versus Birth Control Pills in College Women (ACCEPT)

 Summary: For many women, college is a time of great change that affects one’s social and behavioral practices, including sexual behavior. The first part of the NuvaRing ® Acceptability study is an online survey, developed in conjunction with the University of Illinois’s Survey Research Laboratory, which examines women’s attitudes and beliefs regarding various methods of birth control. The second part of the study is a comparison trial in which the women are randomized to either the NuvaRing ® vaginal contraceptive ring or a low dose oral contraceptive. The women are followed for three months to assess compliance, side effects, overall acceptability and intent to continue use of the method. Ultimately, we would like college women to be well informed about various methods of contraception available to them and to choose the contraceptive method that best suits their lifestyle.
go to top of page

Principle Investigator (s):
Melissa Gilliam MD MPH
Co-Investigators:
Sabrina Holmquist MD, MPH
Amy Whitaker MD

Published articles:
Gilliam M, Neustadt A, Kozloski M, Mistretta S, Tilmon S, Godfrey E. Comparison of adherence and acceptability of the contraceptive ring compared with pills among students: A randomized controlled trial. Obstetrics & Gynecology. March 2010 Abstract

Maintaining IUDS in Teens (MINT)

Summary: While overall use of contraception has been on the rise, use of highly effective, long-acting forms of contraception such as the IUD is significantly lagging among minority teens. Given that IUDS provide long-term protection and do not require daily use or refills, increased use of the device can reduce disproportionate rates of unintended pregnancies among minority adolescents. This feasibility study examines willingness to use and satisfaction with the intrauterine device among teens randomized to either the Copper IUD or Mirena®. It will provide important pilot data for future research studies on intrauterine contraception among teens.

go to top of page

Principle Investigator(s):
Melissa Gilliam MD MPH
Sara Mornar DO
Co-Investigators:
Sabrina Holmquist MD MPH
Sigrid Tristan MD
Amy Whitaker MD MS

Acceptability of NuvaRing ® versus OrthoEvra®

Summary:This study was an open-label prospective, multicenter, randomized trial to compare continuation rates into the fourth cycle of women using either the NuvaRing or OrthoEvra. Five hundred women were recruited at 9 centers nationwide to be randomly assigned to use either the NuvaRing or OrthoEvra for four months. To participate, women had to be either on the pill or have recently stopped the pill and be relatively satisfied with oral contraceptive use to qualify for enrollment. Two visits and two phone calls were required.

go to top of page

Principle Investigator:
Melissa Gilliam MD MPH

Published articles:
Creinin M, Meyn L, Borgatta L, Barnhart K, Jensen J, Burke A, Westhoff C, Gilliam M, Dutton C, Ballagh S. A randomized multi-center comparison of the contraceptive ring and patch. Obstetrics and Gynecology 2008; 111(2):267-277
Abstract

Phase III Clinical Trial of a New 12-Month Vaginal Ring

 Summary : The Population Council has launched a research study examines the safety and efficacy of an experimental contraceptive vaginal ring designed to last for 12 months and contains lower dosage of hormones than the birth control pill. A product that is purchased only once a year may result in lower costs and fewer trips to the doctor or pharmacy. The University of Chicago is one of several sites in the United States and in several countries participating in this study. Preliminary research in women suggests that the one year ring is as effective as oral contraceptives in preventing pregnancy. This study is expected to close in mid-2009 at which point an application to the FDA will be submitted.

go to top of page

Principle Investigator:
Melissa Gilliam MD MPH
Co-Investigators:
Sabrina Holmquist MD, MPH
Mishka Terplan MD, MPH
Amy Whitaker MD
Lisa Memmel MD
Sara Mornar DO

Multi-Center Trial to Evaluate Contraceptive Efficacy, Cycle Control, Safety and Acceptability of a Monophasic Combined Oral Contraceptive

Summary: This Phase III blinded research study examines the safety, effectiveness, acceptability and cycle control of a non- FDA approved combined oral contraceptive pill with four placebo days compared to an FDA approved oral contraceptive pill currently on the market. Women enrolled in the study were randomly assigned to either one of the oral contraceptive pills and completed seven visits over the course of one year.

go to top of page

Principle Investigator:
Melissa Gilliam MD MPH
Creinin M, Meyn L, Borgatta L, Barnhart K, Jensen J, Burke A, Westhoff C, Gilliam M, Dutton C, Ballagh S. A randomized multi-center comparison of the contraceptive ring and patch. Obstetrics and Gynecology 2008; 111(2):267-277
Abstract

Postpartum Adolescent Birth Control Study (PABC)

Summary: Adolescents of color are at risk of rapid repeat pregnancy. The purpose of this study is use a biopsychosocial model to examine ecological, biological, daily life, psychosocial factors that may influence risk of repeat pregnancy among Latina and African American adolescents. This study will provide insight into the natural history of adolescent sexual and contraceptive behavior in the first postpartum year, among two major groups at especially high risk of having a second or higher order unintended birth while teenagers: low-income African American and Latina adolescent girls.
go to top of page

Principle Investigator:
Melissa Gilliam MD MPH

Contraception and Family Planning in Minority Adolescent Men and Women  

Summary: This study examines attitudes towards contraception and teen pregnancy among minority adolescents from the teen and parent perspectives in a focus group setting. It provides insight on how African American and Latino teen males, females, mothers and fathers from local Chicago communities think abut pregnancy, sexual behaviors and norms, sex education, access to and use of contraception, and prevalence of sexually transmitted diseases. We will understand how family, social and environmental factors help shape teens attitudes and behaviors. This study will result in real recommendations for improving communications within teen relationships about birth control counseling; sex education about birth control and pregnancy prevention by schools, parents, and the community; and access to and/or use of newer forms contraception among teens.

go to top of page

Principle Investigator:
Melissa Gilliam, MD MPH

Published articles:
Gilliam ML, Hernandez M. Providing Contraceptive Care to Low-Income, African American Teens: The Experience of Urban Community Health Centers. Journal of Community Health 2007;32(4):231-244. Abstract

Conceptualizing Emergency Contraception: An in-depth interview study

Summary:Emergency contraception (EC) has the potential to greatly decrease the number of unintended pregnancies and abortions in the US. However, it is becoming increasingly clear that EC is being underutilized by American women. Most people attribute this phenomenon to barriers in accessing EC, but a few recent studies have shed doubt on this assumption. Studies suggest that behavioral factors can affect EC use such as negative attitudes towards EC or limited knowledge of the mechanisms of EC and how it differs from RU-486. We are performing a qualitative study to look at how personal characteristics, knowledge, attitudes and decision-making affect a woman’s choice to use EC. The ultimate goal of this research is to inform future educational initiatives and promotion of EC as a method of preventing unintended pregnancy and abortion.

go to top of page

Knowledge, Attitudes, and Practices Regarding the IUD among Women living in Asebu, Ghana

 Summary: Ghana , like many other developing countries, has a high rate of maternal mortality. High numbers of undesired pregnancies and the low rates of modern contraceptive use contribute to maternal mortality. Asebu, a recently-formed farming community located in the Central Region of Ghana is a rural community with limited access to healthcare. Use of modern contraceptives such as the IUD remains low in this region. To better understand reasons behind these low rates, and to gain insight for future policy and health care initiatives, the specific aim of this project is to determine knowledge, attitudes, access to, and practices regarding the IUD among reproductive age women living in Asebu, Ghana from the perspectives of providers and women living in the region. In the Fall of 2007, we conducted focus groups with women of all ages and semi-structured interviews with providers in Asebu, Ghana. A publication synthesizing the results of this study is forthcoming.

go to top of page

Postpartum Sterilization Study

 Summary:Postpartum sterilization is one of the most effective methods of contraception and offers convenience when compared to interval tubal ligation. Despite these beneficial aspects of the procedure, many women who, during prenatal care, express a desire to undergo postpartum sterilization do not have the procedure done. We conducted two complementary studies to examine the factors that influence whether or not a woman obtains a desired postpartum sterilization. Through a retrospective chart review we identified risk factors for failure to obtain a desired postpartum sterilization and barriers to fulfullment. In the related qualitative study, we followed a cohort of mothers prospectively for one year to assess the personal and public health consequences of not obtaining a desired postpartum sterilization. We hope that our research will improve postpartum contraceptive care for women at high risk for unintended pregnancies.

go to top of page

Principle Investigator:
Melissa Gilliam MD MPH

Published articles
Gilliam M, Davis SD, Berlin A, Zite NB. A qualitative study of barriers to postpartum sterilization and women's attitudes toward unfulfilled sterilization requests. Contraception 2008; 77: 44-49. Abstract

Zite N, Wuellner S, Gilliam M. Barriers to obtaining a desired postpartum tubal sterilization. Contraception 73 (2006) 404– 407. Abstract

Zite N, Wuellner S, Gilliam M. Failure to Obtain Desired Postpartum Sterilization: Risk and Predictors. Obstet Gynecol. 2005; 105(4):794-799. Abstract

Contraceptive Use in Young Latinas

 Summary : Latinas have a high rate of unplanned, repeat pregnancies that occur shortly after a previous pregnancy. This phenomenon may be prevented by consistent use of an effective contraceptive method; however, little has been published on Latina contraceptive compliance. In collaboration with the Access Community Health Network, we conducted interviews, focus groups and surveys of the young Latina population who visit these clinics in order to determine contraceptive knowledge, attitudes, and use. Other data such as family expectations regarding premarital sex and birth control, communication with partners and peers about birth control, history of sexually transmitted diseases and other risk behaviors were also collected from Latinas.

go to top of page

Principle Investigator:
Melissa Gilliam MD MPH

Published articles
Gilliam ML, Warden M, Goldstein C, Tapia B. Concerns about Contraceptive Side Effects among Young Latinas: A Focus-Group Approach. Contraception. 2004;70(4):299-305. Abstract

Gilliam M. The Role of Parents and Partners in the Pregnancy Behaviors of Young Latinas. Hispanic Journal of Behavioral Sciences 2007; 29; 50: 50-67
Abstract

Gilliam ML, Berlin A, Kozloski M, Hernandez M, Grundy M. Interpersonal and Personal Factors Influencing Sexual Debut Among Mexican-American Young Women in the United States. Journal of Adolescent Health 2007; 41: 495–503
Abstract