Human Epididymis Protein 4 in Normal Menstruating Women

Women and Infants Hospital of Rhode Island

Status: Unknown

Conditions: Healthy Premenopausal Women

Treatments: Other: blood draws

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01337999

10-0127

Details and patient eligibility

About

The purpose of this study is to determine if Human Epididymis Protein 4 (HE-4) levels vary during the menstrual cycles in ovulatory women. HE-4 is a sensitive serological marker that is elevated in certain ovarian and endometrial cancers and can aid in the diagnosis of these malignant conditions. In order to optimize the utility of HE4 as a tumor marker in premenopausal women, its expression in the normal menstrual cycle needs to be characterized. We hypothesize that HE-4 levels do not vary in the menstrual cycle.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• women age 18-45 years old
• regular menstrual cycles (every 25-35 days)
• normal BMI (19-25)
• no hormonal contraception in the two menstrual cycles prior to enrollment

Exclusion criteria

• pregnancy
• pelvic mass

Trial design

60 participants in 1 patient group

HE-4 levels, healthy premenopausal women

Treatment:

Other: blood draws