Human Epididymis Protein 4 in Normal Menstruating Women

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01337999

Enrollment

Registered

2011-04-19

Start date

2011-03-31

Completion date

Unknown

Last updated

2013-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Premenopausal Women

Brief summary

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.

Interventions

OTHERblood draws

5 blood draws during ovulatory menstrual cycles in premenopausal women

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
HE-4 level	5 times during menstrual cycle

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026