Human Epididymis Protein 4 in Normal Menstruating Women
- Conditions
- Healthy Premenopausal Women
- Interventions
- Other: blood draws
- Registration Number
- NCT01337999
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 60
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HE-4 levels, healthy premenopausal women blood draws -
- Primary Outcome Measures
Name Time Method HE-4 level 5 times during menstrual cycle
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Women & Infants Hospital of Rhode Island, Division of Reproductive Endocrinology & Infertility
🇺🇸Providence, Rhode Island, United States