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Not recruiting

Simvastatin & Duavee

Sponsor:

Penn State University

Code:

NCT05059626

Conditions

Endometriosis

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

simvastatin 10mg

Bazedoxifene 20/Estrogens,Con 0.45Mg Tb

Study Details

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

Study ID

NCT05059626

Start date

Dec 1, 2023

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Simvastatin

30 days of Simvastatin (10mg/day)

other: bazedoxifene + conjugated estrogen

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

Interventions

simvastatin 10mg

Simvastation acts as a systemic LOX inhibitor.

Bazedoxifene 20/Estrogens,Con 0.45Mg Tb

Duavee is a selective estrogen receptor modulator.

Primary outcome measure

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

Central Contacts and Locations

More Information

Sponsor

Penn State University

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by Penn State University on 2026-07-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.