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Human Epididymis Protein 4 in Normal Menstruating Women

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by Women and Infants Hospital of Rhode Island.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Beth Plante, Women and Infants Hospital of Rhode Island Identifier:
First received: April 15, 2011
Last updated: December 16, 2013
Last verified: December 2013
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.

Condition Intervention
Healthy Premenopausal Women
Other: blood draws

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Human Epididymis Protein 4 in Normal Menstruating Women

Further study details as provided by Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • HE-4 level [ Time Frame: 5 times during menstrual cycle ]

Biospecimen Retention:   Samples With DNA

Estimated Enrollment: 60
Study Start Date: March 2011
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HE-4 levels, healthy premenopausal women Other: blood draws
5 blood draws during ovulatory menstrual cycles in premenopausal women


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Ovulating women recruited from local college campuses, doctor's offices and hospitals.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01337999

United States, Rhode Island
Women & Infants Hospital of Rhode Island, Division of Reproductive Endocrinology & Infertility
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Principal Investigator: Beth Plante, M.D. Women and Infants Hospital of Rhode Island