NCT04245540: EPAPD

Effects of Pau d' Arco in Primary Dysmenorrhea

Completed EARLY_PHASE1 Last updated 24 March 2023

What this trial tests

EARLY_PHASE1 trial testing Pau d' Arco in Primary Dysmenorrhea in 12 participants. Completed in 15 December 2022.

Timeline

30 July 2019

Primary endpoint
1 January 2022

15 December 2022

Quick facts

Lead sponsor	National University of Natural Medicine
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	12
Start date	30 July 2019
Primary completion	1 January 2022
Estimated completion	15 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Pau d' Arco

Conditions studied

• Primary Dysmenorrhea — all drugs for Primary Dysmenorrhea →

Sponsor

National University of Natural Medicine

Who can join

Adults 18 to 45, female only, with Primary Dysmenorrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Safety and tolerability of Pau d' Arco (<i>Tabebuia avellanedae)</i> for primary dysmenorrhea: A single-arm, open-label trial on adults ages 18-45.
   McClure C, Bollen M, Buttolph L, Stack E, et al · · 2022 · cited 1× · PMID 36960315 · DOI 10.1016/j.aimed.2022.04.003