Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Penn State University
Study ID
NCT05059626
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • simvastatin 10mg — DRUG
    Simvastation acts as a systemic LOX inhibitor.
  • Bazedoxifene 20/Estrogens,Con 0.45Mg Tb — DRUG
    Duavee is a selective estrogen receptor modulator.

Study Details

Purpose: To determine the effects of SERM and simvastatin interventions on endothelial dysfunction in women with endometriosis. Hypothesis: Treatment with the SERM (bazedoxifene + conjugated estrogen) or with simvastatin will decrease systemic inflammation and improve specific measures of cardiovascular function including endothelium-dependent vasodilation.

Key Dates

Start date
Dec 1, 2023
Status verified
Nov 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
28 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Other: Simvastatin
    30 days of Simvastatin (10mg/day)
  • Other: bazedoxifene + conjugated estrogen
    30 days of bazedoxifene + conjugated estrogen (0.45mg/20mg/day)

Primary Outcome Measure

Change in skin blood flow [ Time Frame: before intervention and 30 days post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The John B. Pierce LaboratoryNew HavenConnecticut06519
Nina Stachenfeld, Ph.D.
[email protected]
203-562-9901

Find similar trials in New Haven, CT

By condition
Endometriosis
By specialty
Women's healthFertility
By research site
The John B. Pierce Laboratory· New Haven, CT

Related Studies