Overview

A single arm, open-label trial evaluating safety and tolerability of encapsulated Tabebuia avellanedae in 12 generally healthy women aged 18-45 with primary dysmenorrhea (PDM). This will be the first study evaluating the safety and tolerability of Tabebuia avellanedae in PDM. We also aim to collect proof-of-concept mechanistic data supporting the hypothesis that Tabebuia avellanedae reduces PGE2 concentration in vivo in women with PDM.

Eligibility

Inclusion Criteria:

• Biologically female
• Ages 18-45
• Presence of primary dysmenorrhea
• Has a 'smart' phone and is willing to download and use an electronic application for use during the study.
• Willing to take a non-hormonal form of birth control throughout the trial period (abstinence, condom, diaphragm, or copper IUD (ParaGard))
• Lives in the Portland area
• Able to speak, read and write English
• Has reliable transportation to clinic
• Willing to have four fasting blood draws taken
• Wiling to collect menstrual fluid in a Diva cup on the first day of menstruation and ability to deliver it to the clinic on the same day
• Ability to receive and complete electronic VAS scales
• Pain scale rating of 6 or higher on the VAS scale
• Monthly pain that correlates with menstruation

Exclusion Criteria:

• Presence of secondary dysmenorrhea
• General health measures outside of normal range:
• Blood pressure readings obtained at the Screening Visit reveal hypotension (90/60 mmHg) or hypertension (140/90 mmHg).
• Aspartate aminotransferase (AST) < 8 U/L or > 48 U/L at the Screening Visit.
• Alanine aminotransferase (AST) < 7 U/L or > 55 U/L at the Screening Visit.
• Estimated glomerular filtration rate (eGFR) < 90 ml/min/1.73m2 at the Screening Visit.
• An INR value > 1.1 at the Screening Visit.
• A red blood cell count < 3.90 million cells/mcL or > 5.03 million cells/mcL.
• A hemoglobin value of < 12 g/dL (120 g/L) or > 15.5 g/dL (155 g/L).
• A hematocrit value of < 34.9% or > 44.5%.
• A white blood cell count < 3.5 billion cells/L (3,500 cells/mcL) or > 10.5 billion cells/L (10,500 cells/mcL)
• A platelet count < 150 billion/L (150,000/mcL) or > 450 billion/L (450,000 mcL).
• Women who are nursing, pregnant, or planning pregnancy in the next four months
• Difficulty swallowing or aversion to capsules, tablets, or pills
• Currently taking, and unwilling to discontinue, NSAIDs (Aspirin, Ibuprofen)
• Currently taking dietary supplements with any of the following ingredients in amounts over 250 mg/day: cinnamon, garlic, ginger, turmeric, and/or curcumin
• Consumption of >1 alcoholic drink per day, during the study period
• Currently taking any anticoagulation medications (Warfarin/Coumadin)
• Currently taking, or have taken in the past two months, hormonal forms of birth control
• Unwillingness, or inability, to take a monthly pregnancy test during the timeline of the study (3 pregnancy tests)
• Past or present medical history of any of the following:
• Blood clotting disorders (von Willebrand disease, Hemophilia A, Hemophilia B, etc.)
• Liver disease (cirrhosis, hepatitis, liver failure, jaundice, liver cancer, etc.)
• Kidney disease (chronic kidney disease, polycystic kidney disease, etc.)
• Cardiac disease (hypertension, heart failure, cardiomyopathy, etc.)
• Anemia (iron deficiency, sickle cell, aplastic, etc.)
• Inflammatory bowel disease
• Irritable bowel syndrome
• Endometriosis
• Obstructive endometrial polyps
• Chronic pelvic inflammatory disease
• Polycystic Ovarian Syndrome
• Adenomyosis
• Intrauterine or pelvic adhesions
• Congenital obstructive mullerian malformations
• Cervical stenosis
• Use of an intrauterine contraceptive device that causes pain
• Pelvic congestion syndrome
• Reproductive cancer (uterine cancer, ovarian cancer, endometrial cancer, etc.)
• Ovarian cysts
• Fibroids
• Uteropelvic junction obstruction