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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is obese as defined as a BMI of 40 - 55.
Subject is a male and is between 18-60 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of two different doses of MP-101, compared to placebo, in obese people.
Who is the study for?
This trial is for male adults aged 18-60 with severe obesity (BMI of 40 - 55) who have stable weight, exercise, and smoking habits. They must be in reasonable health without a recent history of dieting or investigational meds. Participants need to understand English and commit to the study schedule.Check my eligibility
What is being tested?
The study tests Oleoyl-Estrone at two doses (10 mg and 30 mg) compared to a placebo. It's conducted across multiple centers where men will take the assigned treatment orally once daily for 30 days to see its effects on obesity.See study design
What are the potential side effects?
Potential side effects are not specified here but typically may include digestive issues, changes in appetite or metabolism, fatigue, mood swings, and possibly hormonal imbalances due to the nature of the compound being tested.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is between 40 and 55, classifying me as obese.
Select...
I am a man aged between 18 and 60.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate the safety and tolerability
Secondary outcome measures
To evaluate the preliminary efficacy
Find a Location
Who is running the clinical trial?
Manhattan PharmaceuticalsLead Sponsor
2 Previous Clinical Trials
161 Total Patients Enrolled
1 Trials studying Obesity
100 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to visit the research center on the required days.The researcher thinks that you are not a good fit for the study.My BMI is between 40 and 55, classifying me as obese.You have been following a specific diet plan, either formally or informally, in the past 30 days.Subject has maintained a consistent weight over the past month, as per their self-reported findings.You have consistent habits when it comes to smoking and exercise.I have not taken any medication that would exclude me from the trial.I have been diagnosed with cancer, other than nonmelanoma skin cancer.syndrome
A person who has one or more factors of the metabolic syndrome is considered to have the condition.I am generally healthy with no major medical issues.You have taken part in a research study and received an experimental medication within the past 3 months.I am a man aged between 18 and 60.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT00449254 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who meets the necessary requirements to join this clinical trial?
"Eligible individuals for this trial must be obese, between 18-60 years old, and willing to enroll with around 24 other patients."
Answered by AI
If a patient is over the age of 84, can they still qualify for this experiment?
"The age requirements to participate in this study are that you must be an adult, over 18 years old, and younger than 60."
Answered by AI
Are participants still being recruited for this research project?
"According to the website clinicaltrials.gov, this study is not currently recruiting patients. This trial was posted on October 1st 2006 and was last edited June 4th 2007. Although this particular trial has ended, there are 999 other trials that are still looking for candidates."
Answered by AI
What is the FDA's stance on this medication?
"This treatment's safety rating is a 2. While there have been Phase 2 trials assessing the safety of this medication, there is currently no evidence to support its efficacy."
Answered by AI
Who else is applying?
What state do they live in?
New York
Texas
How old are they?
18 - 65
What site did they apply to?
St. Luke's-Roosevelt Hospital
Jean Brown Research
Research Across America
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
1
Why did patients apply to this trial?
What does the trial pay. Seeking help with obesity.
PatientReceived 1 prior treatment
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