ClinicalTrials.gov
ClinicalTrials.gov Menu

Human Epididymis Protein 4 in Normal Menstruating Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01337999
Recruitment Status : Unknown
Verified December 2013 by Beth Plante, Women and Infants Hospital of Rhode Island.
Recruitment status was:  Active, not recruiting
First Posted : April 19, 2011
Last Update Posted : December 17, 2013
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Beth Plante, Women and Infants Hospital of Rhode Island

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.

Condition or disease Intervention/treatment
Healthy Premenopausal Women Other: blood draws

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Human Epididymis Protein 4 in Normal Menstruating Women
Study Start Date : March 2011
Estimated Primary Completion Date : July 2014

Group/Cohort Intervention/treatment
HE-4 levels, healthy premenopausal women Other: blood draws
5 blood draws during ovulatory menstrual cycles in premenopausal women




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

Biospecimen Retention:   Samples With DNA
Serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337999


Locations
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
Abbott
Investigators
Principal Investigator: Beth Plante, M.D. Women and Infants Hospital of Rhode Island