CLINICAL TRIAL

Bazedoxifene 20/Estrogens,Con 0.45Mg Tb for Endometrioma

Recruiting · 18 - 65 · Female · New Haven, CT

This study is evaluating whether a drug or a diet can improve blood flow in women with endometriosis.

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About the trial for Endometrioma

Treatment Groups

This trial involves 3 different treatments. Bazedoxifene 20/Estrogens,Con 0.45Mg Tb is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Experimental Group 1
simvastatin 10mg
DRUG
Experimental Group 2
Bazedoxifene 20/Estrogens,Con 0.45Mg Tb
DRUG
Control Group 3
Placebo
DRUG

Eligibility

This trial is for female patients between 18 and 65 years old. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
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Acetaminophen, which is better known by its brand name, Tylenol, is a medication that is allowed if the subject has acute pain. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: before intervention and 30 days post-intervention
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: before intervention and 30 days post-intervention.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Bazedoxifene 20/Estrogens,Con 0.45Mg Tb will improve 2 primary outcomes and 4 secondary outcomes in patients with Endometrioma. Measurement will happen over the course of before intervention and 30 days post-intervention.

Change in reproductive hormones
BEFORE INTERVENTION AND 30 DAYS POST-INTERVENTION
blood hormone concentrations
Change in LOX-1 activity
BEFORE INTERVENTION AND 30 DAYS POST-INTERVENTION
LOX-1 receptor expression
Change in peripheral blood flow
BEFORE INTERVENTION AND 30 DAYS POST-INTERVENTION
brachial artery flow mediated dilation
Change in skin blood flow
BEFORE INTERVENTION AND 30 DAYS POST-INTERVENTION
cutaneous vascular conductance (units = red cell flux/mean arterial pressure)
Change in inflammation
BEFORE INTERVENTION AND 30 DAYS POST-INTERVENTION
inflammatory cytokine concentration
Change in microRNA activity
BEFORE INTERVENTION AND 30 DAYS POST-INTERVENTION
microRNA expression

Who is running the study

Principal Investigator
L. A.
Prof. Lacy Alexander, Professor of Kinesiology
Penn State University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get endometrioma a year in the United States?

In America, every 4.5 years, approximately 20,000 US women have an endometrioma. The number of women with endometrioma increases as they age, with 15.1% of women aged 50-59 having an endometrioma compared to 35.1% of women aged 60-64, 39.3% of women aged 65-67, and 43.3% of women 70 years and older having an endometrioma. On average each woman with an endometrioma living in America will have the disease for about five years.

Anonymous Patient Answer

Can endometrioma be cured?

Endometrioma can be completely removed in many cases. However, cure is a rare occurrence. The overall chance of a good cosmetic result after surgery is greater than chance of cure and less than chance of severe complication or recurrence.

Anonymous Patient Answer

What are common treatments for endometrioma?

We recommend surgical excision of endometriomas based on clinical indications. The use of anti-inflammatory and estrogen-only hormonal therapy are associated with a more benign type of recurrence.

Anonymous Patient Answer

What are the signs of endometrioma?

Pain is the chief complaint that reflects deep endometrioma. On physical examination, a palpable, nontender uterus, and a palpable, rubbery, mobile uterus is the nonspecific finding that could reflect endometrioma. A palpable painless and red uterus with tenderness in the suprapubic area with or without vaginal bleeding, and a palpable red and tender uterus in the lower quadrant are highly suggestive of endometrioma. The presence of bleeding and the presence of pain during intercourse can also suggest endometrioma. The presence of pelvic adhesions and other nonspecific findings during vaginal examination do not exclude endometrioma.

Anonymous Patient Answer

What causes endometrioma?

Findings from a recent study from this study indicated that, endometrioma is not simply the result of implantation of tissue from the pelvic cavity. Endometrioma appears to be caused not only by hormonal changes, but also by other factors associated with the development of endometriosis.

Anonymous Patient Answer

What is endometrioma?

Endometrioma represents an uncommon intra abdominal benign tumor and is the second most common gynaecological adnexal lesion. The main cause of endometriosis is unopposed estrogen action on endometrial tissue following the ovulation, and the presence of endometrioma is a predisposing factor of endometriosis. The diagnosis of endometrioma is often made by pelvic examination, especially when the endometrioma consists of an enlarged glandular area.

Anonymous Patient Answer

What are the latest developments in bazedoxifene 20/estrogens,con 0.45mg tb for therapeutic use?

It is concluded that the present data suggest that the combination of 20/estrogens/bazedoxifene is of special interest in patients with symptomatic endometriosis whose pain becomes refractory to antiestrogen therapy alone, while the present data also confirm that the addition of testosterone 0.45mg tb has no further advantage as compared with the combination of 20/estrogens/bazedoxifene in these patients; for this reason, the use and maintenance of testosterone 0.45mg tb should not be considered in all patients with symptomatic endometriosis as an alternative to bazedoxifene 20/estrogens.

Anonymous Patient Answer

Does bazedoxifene 20/estrogens,con 0.45mg tb improve quality of life for those with endometrioma?

Bazedoxifene 20/CE,con 0.45 mg tb significantly reduces severity of illness for patients with endometrioma and positively affects QoL. The reduction of disease-related pain,surgical indications and the overall disease severity with this regimen seem to be due to a hormonal effect of estrogen on endometrial tissue rather than from a direct effect on endometrioma.

Anonymous Patient Answer

Is bazedoxifene 20/estrogens,con 0.45mg tb safe for people?

Bazedoxifene 1 mg/25mg tb +con 0.45 mg tb +con 0.05 mg orcon 0.25 mg tb are safe, effective with no adverse effects, and can help women with endometriosis.

Anonymous Patient Answer

Is bazedoxifene 20/estrogens,con 0.45mg tb typically used in combination with any other treatments?

In terms of effectiveness and tolerability, bazedoxifene 20/estrogen combination therapy should be preferable and should be considered a cornerstone treatment for endometriosis if there are no contraindications.

Anonymous Patient Answer

Who should consider clinical trials for endometrioma?

Women who have had multiple surgical or radiologic interventions for endometriosis have a similar frequency of histological endometrioma at the time of referral to and completion of the trial. Therefore, clinical trials should not be withheld from this subset of women with endometriosis who are willing to participate in a trial of this intervention, but only after careful consideration. Those who do not wish to be included in an endometrioma clinical trial should not be denied the opportunity to participate and should be encouraged when it is not possible to include them.

Anonymous Patient Answer
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