Human Epididymis Protein 4 in Normal Menstruating Women

Status unconfirmed

Conditions studied: Healthy Premenopausal Women

In brief

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.

Key facts

Study ID

NCT01337999

Run by

Women and Infants Hospital of Rhode Island

People needed

60

Starts

2011-03-01

Last updated by the study team

2013-12-17

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• pregnancy
• pelvic mass

Where it is running

• Women & Infants Hospital of Rhode Island, Division of Reproductive Endocrinology & Infertility — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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