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Trial Outcomes & Findings for MicroRNA Activation of LOX-1 Mechanisms in Endometriosis (NCT NCT05331053)

NCT ID: NCT05331053

Last Updated: 2025-01-30

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

6 participants

Primary outcome timeframe

before and after intervention (7 days)

Results posted on

2025-01-30

Participant Flow

All endometriosis patients had a confirmed diagnosis prior to enrollment via laparoscopy.

6 enrolled

Participant milestones

Participant milestones
Measure
Atorvastatin
Oral atorvastatin (Lipitor) therapy (10mg/day) for seven days.
Overall Study
STARTED
6
Overall Study
COMPLETED
6
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MicroRNA Activation of LOX-1 Mechanisms in Endometriosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Atorvastatin
n=6 Participants
Oral atorvastatin (Lipitor) therapy (10mg/day) for seven days. Atorvastatin acts as a systemic LOX inhibitor. Atorvastatin: Simvastation acts as a systemic LOX inhibitor.
Age, Continuous
33 years
STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
5 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
6 Participants
n=5 Participants

PRIMARY outcome

Timeframe: before and after intervention (7 days)

Population: A subset (n = 6) of endometriosis patients participated in a seven-day oral atorvastatin (Lipitor®) therapy (10 mg/day). These subjects returned to the laboratory on day 7, having taken the final dose that morning.

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

Outcome measures

Outcome measures
Measure
Atorvastatin
n=6 Participants
Oral atorvastatin (Lipitor) therapy (10mg/day) for seven days. Atorvastatin acts as a systemic LOX inhibitor. Atorvastatin: Simvastation acts as a systemic LOX inhibitor.
Change in Nitric Oxide Dependent Vasodilation in the Skin
200 flux/MAP*logAch(mol/L)
Standard Error 80

Adverse Events

Atorvastatin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lacy M. Alexander, Ph.D.

Penn State University

Phone: 8148671781

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place