White Paper

Capabilities For Clinical Studies In Contraception

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The Quest for the Ideal Combination of Contraceptive Efficacy, Safety, Convenience and Quality of Life

Women today can choose from a wide range of effective and safe contraceptives and yet satisfaction with existing methods varies. Many women change methods for a variety of reasons, sometimes including concerns about side effects. Researchers continue the quest for a product that offers the optimal combination of efficacy, safety, convenience and quality of life. The Health Decisions 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, multiyear studies evaluating long-acting reversible contraceptives (LARCs). We have also conducted ten studies of investigational male hormonal contraceptives. The Health Decisions network includes sites with experience in all types of contraceptive trials.

"Researchers continue the quest for a product that offers the optimal combination of efficacy, safety, convenience and quality of life."

Operational and Methodological Considerations in Contraception Trials

Contraception studies involve a variety of unique operational and methodological considerations that may vary at different stages of development. Considerations in contraceptive trials may include: 

  • In early-phase trials, postcoital testing of safety, fit and acceptability of an investigational device, requiring 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, establishing the cycle’s relevance to the evaluation of contraceptive efficacy.
  • A high burden of study participation requiring subject compensation. Patients must often be willing to risk pregnancy as well as 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.
  • Recruitment of women who are not only willing to comply with trial requirements themselves but also have partners willing to accept trial requirements.
  • Subject retention issues, especially in multiyear safety and efficacy trials, as enrolled subjects change employment and place of residence.
  • Site training in the unique properties and correct administration or insertion of each drug or device.
  • Patient education to set realistic expectations about short-term and long-term side effects and risks, e.g. side effects following IUD insertion, the risk of expulsion and the importance of product removal at the end of a trial.
  • Determination of the effects of the investigational product on important subpopulations such as women with Body Mass Index (BMI) exceeding a specified value.

Key Risks and Mitigations in Contraception Studies

Risk 1: Delays in Patient Recruitment

Mitigations 

  • Utilize sponsor- and IRB-approved pre-screening and screening tools such as questionnaires, site posters, recruitment brochures, social media postings, and centrally managed social media presence, enabling each site to select the best tools for its individual site population.
  • Complement a centrally managed recruitment strategy with funding for local advertising by sites.
  • Provide a subject stipend perceived by subjects as appropriate for completing a study requiring use of an investigational contraceptive and maintaining a diary for an extended period while also acceptable to Institutional Review Boards.

Risk 2: Subject Discontinuation

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Mitigations

  • Create an Informed Consent Form with well-defined subject responsibilities, making subject expectations clear from the start of participation.
  • Provide sites with tools for communication and train sites to communicate well, clearly, and often with subjects about upcoming visits, assessments and expectations.
  • For a phase 3 study with many subjects and geographically diverse sites, implement a program for transfer of relocating subjects whenever possible from their existing site to a site within driving range of their new address

For Assistance With Your Contraception Program

As a CRO committed to improving healthcare outcomes for women, Health Decisions is committed to assisting developers in increasing the variety and range of acceptable contraceptives so that each woman can identify a contraceptive solution that meets her needs.  The Health Decisions clinical team understands the key issues and risks in contraception trials and how to mitigate them.  We have often assisted contraceptive developers in meeting their scientific, informational and business goals. Moreover, our medical, clinical and biostatistical staff have experience supporting NDAs for novel contraceptives, including working with FDA’s Division of Bone, Reproductive and Urologic Products (DBRUP). Please contact us to explore how Health Decisions can assist with efficient, timely development of your investigational contraceptive.

1  Johnson S, Pion C, Jennings V. Current methods and attitudes of women towards contraception in Europe and America. Reproductive Health 2013, 10:7.

The Leading Full-Service Women’s Health CRO from Pre-IND or -IDE to Regulatory Approval and Beyond
Health Decisions is a full-service CRO specializing in clinical development of drugs, diagnostics, medical devices and combination drug/devices in all areas of women’s health as well development of diagnostics for all therapeutic areas. Our experience, expertise, site network and KOL and investigator relationships enable us to address the challenges of developing women’s health products in areas including general gynecology indications, contraception, sexual health, infertility, obstetrics, menopause and osteoporosis and other indications that affect women disproportionately and profoundly, including autoimmune disorders and malefactor infertility. Health Decisions is headquartered in Durham, NC.