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Protein Tracer Drink to Study Muscle Growth Influence by Oral Contraceptives (OCEV Trial)
N/A
Recruiting
Research Sponsored by University of Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
BMI between 18.5-29.9 kg/m2 (non-obese)
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes
Awards & highlights
OCEV Trial Summary
This trial aims to close the gender gap in muscle research, investigating how sex hormones and oral contraceptives influence muscle growth.
Who is the study for?
This trial is for non-obese women with a BMI of 18.5-29.9 who either use monophasic oral contraceptives for more than 3 months or have regular menstrual cycles and haven't used oral contraceptives for at least 6 months.Check my eligibility
What is being tested?
The study tests how sex hormones and oral contraceptives affect muscle protein metabolism using an ex vivo model, where human serum is applied to mouse muscle cells instead of invasive tracer studies in humans.See study design
What are the potential side effects?
Since this trial uses an ex vivo model rather than direct medication, participants are not expected to experience side effects from the intervention itself.
OCEV Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is between 18.5 and 29.9, so I am not obese.
OCEV Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Protein Synthesis (Murine Cell-Based Experiments, ex-vivo experiments)
Secondary outcome measures
Urinary Measures (Muscle Protein Breakdown)
Whole-body protein synthesis
OCEV Trial Design
4Treatment groups
Experimental Treatment
Group I: Withdrawal phaseExperimental Treatment1 Intervention
48hrs after last pill (during placebo pill phase).
Group II: Mid-Luteal PhaseExperimental Treatment1 Intervention
5-9 days after ovulation (as confirmed with ovulation test kits).
Group III: Mid-Follicular PhaseExperimental Treatment1 Intervention
7-11 days after onset of menses.
Group IV: Active pill phaseExperimental Treatment1 Intervention
10-20 days after starting new pill cycle.
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Who is running the clinical trial?
University of TorontoLead Sponsor
694 Previous Clinical Trials
1,020,136 Total Patients Enrolled
Jonathan Aguilera, PhD StudentStudy DirectorUniversity of Toronto
1 Previous Clinical Trials
10 Total Patients Enrolled
Cassidy Tinline-Goodfellow, PhD (C)Study DirectorUniversity of Toronto
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