Status:
WITHDRAWN
Endometriosis Biomarker Discovery Study
Lead Sponsor:
Myriad Genetic Laboratories, Inc.
Conditions:
Chronic Pelvic Pain
Endometriosis
Eligibility:
FEMALE
18-45 years
Brief Summary
This is a prospective, Single time point, discovery study intending to identify biomarkers that can differentiate endometriosis from other underlying reasons for pelvic pain. Patients undergoing lapar...
Detailed Description
This study will be a prospective collection of blood, urine, and endometrial tissue from women with chronic pelvic pain symptoms, with or without infertility, who require evaluation by laparoscopy. Wo...
Eligibility Criteria
Inclusion
- Able to give informed consent.
- Aged 18-45 years old who has a regular menstrual cycle (26 to 32 days in length).
- Undergoing a planned diagnostic or therapeutic laparoscopy for the indication of pelvic pain or for elective tubal ligation.
- One prior pregnancy for tubal ligation patients.
Exclusion
- Prior surgical diagnosis of endometriosis.
- Currently pregnant or breastfeeding.
- Clinical suspicion of pelvic inflammatory disease (PID) or urinary tract infection.
- Current malignancy except non-melanoma skin cancer adequately treated.
- Known major systemic disease, including but not limited to inflammatory disease, autoimmune disease.
- Use of immunosuppressants in the past 3 months.
- Use of injectable reproductive hormonal therapy within the past 3 months and have not menstruated since last dose.
- If reproductive hormonal implant has been used in the past, it must have been removed \> 3 months prior to study entry and subject must have menstruated since removal.
- Use of intrauterine device (IUD) in the past 3 months.
- Use of any other reproductive hormone therapy within the past 3 months, except for oral contraceptives (OCPs).
Key Trial Info
Start Date :
September 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03272360
Start Date
September 1 2016
End Date
June 1 2017
Last Update
September 5 2017
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