NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee
Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee

NCT05059626

Enrolling By InvitationPhase 4

Sponsor: Penn State University

Conditions: Endometriosis

Interventions: simvastatin 10mg, Bazedoxifene 20/Estrogens,Con 0.45Mg Tb

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 45 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
Locations (1)
  • New Haven, Connecticut, United States