Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee

NCT05059626 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 18347
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometriosis

Keywords

Skin blood flow; Estrogen; Selective Estrogen Receptor Modulator; Intradermal Microdialysis

Outcome Measures

Primary Outcomes (2)

• Change in skin blood flow

  cutaneous vascular conductance (units = red cell flux/mean arterial pressure)

  before intervention and 30 days post-intervention

• Change in peripheral blood flow

  brachial artery flow mediated dilation

  before intervention and 30 days post-intervention

Secondary Outcomes (4)

• Change in LOX-1 activity

  before intervention and 30 days post-intervention

• Change in reproductive hormones

  before intervention and 30 days post-intervention

• Change in inflammation

  before intervention and 30 days post-intervention

• Change in microRNA activity

  before intervention and 30 days post-intervention

Study Arms (2)

Simvastatin

OTHER

30 days of Simvastatin (10mg/day)

Drug: simvastatin 10mg

bazedoxifene + conjugated estrogen

OTHER

30 days of bazedoxifene + conjugated estrogen (0.45mg/20mg/day)

Drug: Bazedoxifene 20/Estrogens,Con 0.45Mg Tb

Interventions

simvastatin 10mg DRUG

Simvastation acts as a systemic LOX inhibitor.

Simvastatin

Bazedoxifene 20/Estrogens,Con 0.45Mg Tb DRUG

Duavee is a selective estrogen receptor modulator.

bazedoxifene + conjugated estrogen

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• 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 \<10 years prior, and reported by the subject to the researchers)
• Tylenol if the subject has acute pain is allowed
• IUD contraceptive use (copper or levonogestrel) is allowed

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
• The John B. Pierce Laboratory: collaborator

Study Sites (1)

The John B. Pierce Laboratory

New Haven, Connecticut, 06519, United States

RECRUITING

MeSH Terms

Conditions

Endometriosis

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Central Study Contacts

Lacy M Alexander, PhD

CONTACT

814-867-1781; lma191@psu.edu

Susan K Slimak, RN

CONTACT

814-863-8556; sks31@psu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: These treatments are blinded to the investigators. The subjects, physician, and the nurse on staff knows which treatment the subject is taking if there are any questions or safety concerns.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Kinesiology

Model Details: This is a single arm randomized study. Only women with endometriosis will complete this study. Once consented and screened, each subject is block randomized to either 30 days of a treatment (Simvastatin or 30 days of SERM (bazedoxifene + conjugated estrogen; BZE+CE)). This will be done in a counterbalanced fashion. Subjects will have the option of completing the other arm of the study but will undergo a 60 day washout to mimimize carry over effect. We will use Research Randomizer software. These treatments are blinded to the investigators collecting the data and performing the data analysis.

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 28, 2021
• Study Start: December 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)