Women’s Health Clinical Research Capabilities
WCCT offers early clinical development solutions for sponsors developing diagnostic and therapeutic products with target indications in the area of Women’s Health. WCCT combines site ownership with a network of community physicians to support the design, recruitment, conduct, and oversight of studies in this therapeutic area.
WCCT has conducted over 25 clinical trials in the area of Women’s Health. WCCT’s clinical pharmacology unit is located in a densely populated area, which allows access to a diverse patient population in terms of age, ethnicity, lifestyle, and health condition. The result is a varying make-up of WCCT’s patient database which is comprised of nearly 25,000 women who are actively interested in receiving information on appropriate clinical trials. Below is a sampling of our experience in this area.
Early Clinical Development
WCCT has served as a partner for early phase trials in the following areas related to Women’s Health:
- Pregnancy tests
- Post-menopausal women
- Menstruation complications
WCCT is capable of conducting the following procedures and assessments relevant to clinical trials in Women’s Health on-site at its Clinical Pharmacology Unit:
- Pap smears
- Gynecological & Breast exams
- Transvaginal ultrasounds
- Follicular monitoring
DOWNLOAD A CASE STUDY
Case study on Oral Contraceptive Trial in Women of Child-Bearing Potential.
Sample Experience List
Women’s Health Case Studies
Large Volume Pregnancy Test
Population: 102 healthy non-pregnant and 102 healthy pregnant females in their first trimester of pregnancy.
Enrollment Period: 5 months
Study Design: Early-detection pregnancy diagnostic whereby volunteers underwent a series of four pregnancy tests: twice with the investigational device, once with an approved device, and once through a blood test. Device needed to generate results accurately in 99.9% of tests.
Challenges: Due to the first trimester requirement, volunteers could not be easily identified through OBGYNs; requiring WCCT to launch a comprehensive marketing and recruitment campaign.
Results: WCCT successfully enrolled 204 volunteers within the required timeframe, allowing the Sponsor to meet an important corporate milestone.
Extended Confinement Study in Women of Childbearing Potential
Population: 32 healthy women of childbearing potential, ages 21-40, on a stable regimen of oral control or hormonal contraceptives
Enrollment Period: 3 months
Study Design: Open-label, multiple-dose, single sequence, crossover
- Screening Period of up to 28 days prior to the beginning of the Study Period
- Optional “Lead-In” cycle lasting up to 28 days prior to Cycle 1
- Cycle 1 lasting up to 28 days, including Oral Contraceptive treatment on Day 1 to 20
- Cycles 2 and 3 lasting up to 57 days including:
• Confinement period of 35 nights
• Follow-up visit approximately 28 days following discharge
- Identifying eligible subjects who were willing to be confined for 35 nights.
- Training OC-naive volunteers on proper usage (at home dosing) and ensuring compliance of contraceptive use reporting throughout the entire study.
Results: WCCT successfully enrolled 32 volunteers within the required time frame, of which 27 completed all activities, allowing the Sponsor to move onto the next stage of development with this particular asset.