MicroRNA Activation of LOX-1 Mechanisms in Endometriosis

NCT05331053 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: STUDY00009584
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Endometriosis is a disorder that occurs in women. With endometriosis, tissue that should be found in the womb is found in sites outside of the womb. This disorder impairs the function of the cells that line the body's blood vessels (endothelium). The endothelium helps to control blood flow in healthy vessels. Women with this disorder have an increased risk for high blood pressure and high cholesterol. They have a higher risk for cardiovascular disease, too. With this study, we will learn how endometriosis impairs the lining of blood vessels and increases the risk for disease.

Conditions

Endometriosis

Keywords

Skin blood flow; Cholesterol; Statin; Intradermal Microdialysis

Outcome Measures

Primary Outcomes (1)

• Change in Nitric Oxide Dependent Vasodilation in the Skin

  area under the curve of laser Doppler flux/mean arterial pressure \* log acetylcholine (mol/L)

  before and after intervention (7 days)

Study Arms (1)

Atorvastatin

EXPERIMENTAL

Oral atorvastatin (Lipitor) therapy (10mg/day) for seven days. Atorvastatin acts as a systemic LOX inhibitor.

Drug: Atorvastatin

Interventions

Atorvastatin DRUG

Simvastation acts as a systemic LOX inhibitor.

Atorvastatin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women between the ages of 18 and 45 years with endometriosis (diagnosis by prior laparoscopy by subject's own physician \<5 years prior, and reported by the subject to the researchers)

You may not qualify if:

• Use of nicotine-containing products (e.g. smoking, chewing tobacco, etc.)
• Diabetes (HbA1C .6.5%)
• BP\>140/90
• Taking pharmacotherapy that could alter peripheral vascular control (e.g. insulin sensitizing, cardiovascular medications)
• Pregnancy
• Breastfeeding
• Taking illicit and/or recreational drugs
• Abnormal liver function
• Rash, skin disease, disorders of pigmentation, known skin allergies
• Diagnosed or suspected metabolic or cardiovascular disease
• Persistent unexplained elevations of serum transaminases
• Known allergy to latex or investigative substances

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16801, United States

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Lacy M. Alexander, Ph.D.
• Organization: Penn State University

lma191@psu.edu

8148671781

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Kinesiology, Physiology

Model Details: Only women with endometriosis will complete this study. Once consented and screened, each subject is asked to take Atorvastatin (Lipitor, 10mg/day) for seven days. Participants will undergo experimental testing before and after the seven day intervention.

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 15, 2022
• Study Start: May 1, 2018
• Primary Completion: June 1, 2022
• Study Completion: August 31, 2024
• Last Updated: January 30, 2025
• Results First Posted: February 28, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)