Human Epididymis Protein 4 in Normal Menstruating Women

Women and Infants Hospital of Rhode Island60 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Healthy Premenopausal Women

Interventions

blood drawsOTHER

5 blood draws during ovulatory menstrual cycles in premenopausal women

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Women & Infants Hospital of Rhode Island, Division of Reproductive Endocrinology & Infertility

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

HE-4 level

Time frame: 5 times during menstrual cycle

Data from ClinicalTrials.gov

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