Women’s Health Clinical Research Capabilities

NOERA offers early clinical development solutions for sponsors developing diagnostic and therapeutic products with target indications in the area of Women’.s Health. NOERA combines site ownership with a network of community physicians to support the design, recruitment, conduct, and oversight of studies in this therapeutic area, leading to women’s health clinical research capabilities impressive and effective.

NOERA has conducted over 25 clinical trials in the area of Women’s Health. NOERA’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 NOERA’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

Clinical Development Highlights

NOERA has served as a partner for early phase trials in the following areas related to Women’s Health:

• Contraception
• Pregnancy tests
• Post-menopausal women
• HPV/HSV
• Menstruation complications
• Others

NOERA 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

Women’s Health Clinical Research 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 NOERA to launch a comprehensive marketing and recruitment campaign.

Results:  NOERA successfully  enrolled 204 volunteers within the required timeframe, allowing the Sponsor to meet an important corporate milestone.

Oral Contraceptive Trial 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

Challenges:

• 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: NOERA 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.