With a rigorous at-home and in-office assessment schedule, a contraceptive device trial highlights challenges of conducting women’s reproductive health research
By: Jessica Hatheway, Program Director, Health Decisions
Designing a study that will accurately assess the performance of a contraceptive product requires consideration for numerous factors, including the accuracy of measurement tools, the sexual activity of study participants, and the often unpredictable nature of the female reproductive system. In a study assessing the ability of a non-hormonal contraceptive ring to prevent sperm from penetrating midcycle cervical mucus, a demanding assessment schedule, reliance on over-the-counter ovulation kits, and requirements for timely sexual intercourse were among the challenges that had to be surmounted by the clinical research team.
- Safety and acceptability of a non-hormonal contraceptive ring
- Feasibility study
- 23 participants
- 6 US sites
- Number and timing of clinic visits
- Self-assessment procedures
- Inconsistency of women’s natural ovulation cycles
- Accuracy of ovulation test
At a pre-determined point in the menstrual cycle, participants monitored ovulation daily at home, returning to the clinic during peak ovulation, as indicated by the home test, for a cervical mucus exam. If cervical mucus was not optimal, it would require daily visits to the clinic by the subject, which was disruptive and burdensome to their daily routine. If the exam found cervical mucus was optimal, participants were to have vaginal intercourse within 24 hours, followed by a post-coital cervical exam within three hours. This required strong coordination and communication between the site, the subject, and their partner, given the windows around intercourse and follow up at the site. Sites were asked to maintain flexible weekday and weekend hours, given the complicated exam schedule. Additionally, participants and their partners received appropriate stipends to offset the significant time commitment.
In addition to scheduling, recording peak ovulation presented challenges. Women’s ovulation schedules are unique, with some women ovulating more regularly than others. If a woman failed to record peak ovulation by a given point in a menstrual cycle, the potential cause had to be determined. Namely, a participant may have received an ineffective predictor kit, may not have complied with the protocol, or simply may not ovulate within the month. A decision then had to be made as to whether 1) a new ovulation kit would be provided, or 2) the cycle would not be utilized (despite the risk of added expenses and lengthened timelines). Daily meetings between Site, CRO, and Sponsor ensured prompt, consistent, and clear decisions in real-time.
Despite the numerous challenges, sufficient cycles were recorded to complete the statistical analysis. Education, coupled with monetary incentives and scheduling flexibility, helped retain compliant trial participants, with more than 60 percent of subjects completing the study, which exceeded expectations given study complexity. Systematic communication involving key decisionmakers minimized the risk of added costs and altered timelines.
Health Decisions has unmatched expertise in contraceptive clinical research, having supported more than 40 contraceptive clinical trials and serving as the Statistical and Clinical Coordinating Center (SCCC) for the Contraceptive Clinical Trials Network (CCTN) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), a unit of the National Institutes of Health (NIH) since 1996. Contact us to speak with a contraceptive research expert.