This trial is active, not recruiting.

Condition healthy premenopausal women
Treatment blood draws
Sponsor Women and Infants Hospital of Rhode Island
Collaborator Abbott
Start date March 2011
End date July 2014
Trial size 60 participants
Trial identifier NCT01337999, 10-0127


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
blood draws
5 blood draws during ovulatory menstrual cycles in premenopausal women

Primary Outcomes

HE-4 level
time frame: 5 times during menstrual cycle

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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

Additional Information

Official title Human Epididymis Protein 4 in Normal Menstruating Women
Principal investigator Beth Plante, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Women and Infants Hospital of Rhode Island.