Women today can choose from a wide range of effective and safe contraceptives based on their medical and lifestyle needs. Over the course of their lives, women may change contraceptive methods for a variety of reasons, such as concerns about side effects. For researchers, the objective of contraceptive development is to design products that offer the optimal combination of efficacy, safety, convenience, and quality of life.
In this blog post, we provide background on contraceptive choice and explore key operational and methodological considerations for clinical studies.
Balancing efficacy, safety, convenience, and quality of life
Operational and methodological considerations in contraceptive trials
Contraception studies involve a variety of unique operational and methodological considerations that may vary depending on stage of development. Such considerations include:
- Postcoital testing of safety, fit, and acceptability of an investigational device in early-phase trials, which requires a population of sexually active women not at risk for pregnancy due to previous female tubal sterilization and willing to visit a site in a timely manner for examination following intercourse.
- Completion of patient diaries for such reasons as collecting bleeding data and providing evidence of sexual activity and backup contraception during a menstrual cycle to establish the cycle’s relevance to the evaluation of contraceptive efficacy.
- High burden of study participation requiring commensurate study compensation. Patients must often be willing to risk pregnancy, keep diaries of sexual activity, and comply with protocol requirements over long periods. Subject compensation must be appropriate for the perceived burden of study participation and acceptable to Institutional Review Boards (IRBs).
- Recruitment of participants who are willing to comply with trial requirements themselves and have partners who are also willing to accept trial requirements.
- Retention issues, which are particularly important in multi-year safety and efficacy trials, as enrolled subjects change jobs or relocate.
- Site training in the unique properties and correct administration or insertion of each drug or device.
- Patient education about short-term and long-term side effects and risks, including side effects following intrauterine device insertion, the risk of expulsion, and the importance of removing the product at the end of a trial.
- Subpopulation analyses for determining the effects of the investigational product on important patient segments such as women with a body mass index exceeding a specific value.
Key risks and mitigations in contraceptive studies
Risk 1: Delays in patient recruitment
Contraceptive studies may suffer from delays in recruitment. Potential strategies for mitigating recruitment delays include:
- Developing a variety of sponsor- and IRB-approved pre-screening and screening tools such as recruitment brochures, site posters, questionnaires, social media postings, and a centrally managed social media presence, enabling each site to select the best tools for its individual site population.
- Complementing a centrally managed recruitment strategy with funding for local advertising by individual sites.
- Providing a study stipend that is both acceptable to IRBs and perceived by subjects to be appropriate for completing a study requiring use of an investigational contraceptive and maintaining a diary for an extended period.
Risk 2: Subject discontinuation
Due to the perceived burden associated with contraceptive trials, study participants may want to discontinue. Potential strategies for minimizing subject discontinuation include:
- Making study expectations clear from the start of participation by creating an informed consent form with well-defined subject responsibilities.
- Providing sites with communication tools and training sites to communicate with subjects clearly and frequently about upcoming visits and assessments.
- For Phase 3 studies with many subjects and geographically diverse sites, implementing a program for relocating subjects to sites within easy driving distance of their homes.
Assistance with your contraceptive program
At Premier Research, our clinical operations and biostatistical teams understand the challenges involved in all types of contraception studies. Our experience includes designing, managing and/or monitoring clinical studies of all types of contraceptive drugs, devices and drug/device combinations. This includes oral contraceptives, intrauterine devices and systems, vaginal rings, transdermal patches, injections, gels, creams, and barrier devices.
We have conducted small postcoital studies evaluating device safety, fit, and acceptability; studies evaluating products for short-term episodic use like emergency contraceptives and male and female condoms; and multi-year studies evaluating long-acting reversible contraceptives. We have also conducted studies of investigational male hormonal contraceptives. Our network includes sites with experience in all types of contraceptive trials.
As a CRO committed to improving healthcare outcomes for women, Premier Research is dedicated to helping sponsors increase the variety and range of acceptable contraceptives so that each woman can identify the contraceptive solution that best meets her needs. To learn more about our women’s health clinical trial expertise, click here.