Bazedoxifene 20/Estrogens,Con 0.45Mg Tb for Endometrioma
This study is evaluating whether a drug or a diet can improve blood flow in women with endometriosis.
See full descriptionAbout 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.
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.
Approximate Timelines
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.
Who is running the study
Principal InvestigatorPatient Q & A Section
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.