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.
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:
Key Risks and Mitigations in Contraception Studies
Risk 1: Delays in Patient Recruitment
Risk 2: Subject Discontinuation
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.