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Human Epididymis Protein 4 in Normal Menstruating Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Women and Infants Hospital of Rhode Island.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Abbott
Information provided by:
Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT01337999
First received: April 15, 2011
Last updated: April 18, 2011
Last verified: April 2011
History of Changes
  Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Menstruation
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum


Estimated Enrollment: 60
Study Start Date: March 2011
Groups/Cohorts Assigned Interventions
HE-4 levels, healthy premenopausal women Other: blood draws
5 blood draws during ovulatory menstrual cycles in premenopausal women

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337999

Locations
United States, Rhode Island
Women & Infants Hospital of Rhode Island, Division of Reproductive Endocrinology & Infertility Recruiting
Providence, Rhode Island, United States, 02903
Contact: Beth Plante, M.D.     412-274-1122     bplante@wihri.org    
Principal Investigator: Beth Plante, M.D.            
Sub-Investigator: Richard Moore, M.D.            
Sub-Investigator: Sandra Carson, M.D.            
Sub-Investigator: Geralyn Messerlian, Ph.D.            
Principal Investigator: Wendy Vitek, M.D.            
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Abbott
Investigators
Principal Investigator: Beth Plante, M.D. Women and Infants Hospital of Rhode Island
  More Information

Publications:

Responsible Party: Beth Plante, M.D., Women & Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT01337999     History of Changes
Other Study ID Numbers: 10-0127
Study First Received: April 15, 2011
Last Updated: April 18, 2011
Health Authority: Women & Infants Hospital Institutional Review Board, US:
Beth Plante, M.D. - Division of Reproductive Endocrinology & Infertility at Women & Infants Hospital of Rhode Island, US:
United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013