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New treatment option for Endometriosis
Official title Endometriosis and Microvascular Dysfunction: Role of Inflammation
ClinicalTrials.gov ID: NCT05069740
What this study is testing
What is Salsalate Pill?
Salsalate Pill is an investigational medicine, being studied as a potential treatment for endometriosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to better understand the underlying mechanisms associated with elevated cardiovascular disease risk in women with endometriosis, and to measure the effectiveness of emerging endometriosis treatments on outcomes specific to cardiovascular dysfunction. Epidemiologic data demonstrate a clear association between endometriosis, reproductive risk factors, inflammation and cardiovascular (CV) risk.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- Healthy women between the ages of 18 and 45 years (Controls), taking oral contraceptive or with regular menses every 26-34 days
- Women between the ages of 18 and 45 years with endometriosis (diagnosis by prior laparoscopy by subject's own physician \<5 years prior, and reported...
- Tylenol if the subject has acute pain is allowed
- Contraceptive use is allowed
You likely can't join 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
See the full eligibility criteria
- Healthy women between the ages of 18 and 45 years (Controls), taking oral contraceptive or with regular menses every 26-34 days
- Women between the ages of 18 and 45 years with endometriosis (diagnosis by prior laparoscopy by subject's own physician \<5 years prior, and reported by the subject to the researchers)
- Tylenol if the subject has acute pain is allowed
- Contraceptive use is allowed
- 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 (including salsalate or simvastatin)
- History of gastrointestinal bleeding
The study team makes the final eligibility decision.
Where it's taking place
- University Park, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include University Park, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.