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Rapamycin for Perimenopause (Rapamycin Trial)
Phase 2
Recruiting
Led By Samuel Z. Williams, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Rapamycin Trial Summary
This trial will explore if a low dose of rapamycin can slow or reverse aging in the ovaries of women. Results of animal studies suggest it may be possible.
Who is the study for?
This trial is for women aged 38-45 in the early stages of menopause, who have struggled with fertility due to diminished ovarian reserve. They should still have regular menstrual cycles and specific hormone levels within a set range. It's not suitable for those outside this age group or stage of menopause.Check my eligibility
What is being tested?
The study tests if low-dose Rapamycin can delay the process of ovarian aging compared to a placebo. Participants won't know which one they're getting as it's a double-blind study, meaning neither the participants nor the researchers know who receives Rapamycin or placebo until after the results are collected.See study design
What are the potential side effects?
While side effects aren't detailed here, Rapamycin may commonly cause mouth sores, diarrhea, nausea, and skin issues like acne or rash. More serious but less common risks include lung problems and increased susceptibility to infections.
Rapamycin Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measure of Ovarian Reserve
Secondary outcome measures
AMH level
Estradiol (E2) Level
FSH Level
+1 moreSide effects data
From 2009 Phase 4 trial • 20 Patients • NCT0022367831%
pneumonia
15%
acute kidney failure
8%
dehydration
8%
hip replacement
8%
acute rejection
8%
total abdominal hysterectomy and salpingectomy
8%
anemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rapamycin Group
CNI Group
Rapamycin Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RapamycinExperimental Treatment1 Intervention
Participants randomized to the treatment arm will receive 5mg/week of rapamycin orally, for 12 weeks (3 months).
Group II: PlaceboPlacebo Group1 Intervention
Participants randomized to the placebo arm will receive placebo orally, for 12 weeks (3 months).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rapamycin
2008
Completed Phase 4
~1200
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,433 Previous Clinical Trials
2,447,209 Total Patients Enrolled
Samuel Z. Williams, MDPrincipal InvestigatorColumbia University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My menstrual cycles are irregular.I cannot take rapamycin due to health reasons.I have a serious health condition, including any form of cancer.I am a woman aged between 38 and 45.I have fertility issues due to low ovarian reserve and have not succeeded with IVF.I have kidney or liver disease.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Rapamycin
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities currently available to join this clinical trial?
"As indicated on clinicaltrials.gov, this study is not recruiting patients at present despite initially being posted April 1st of 2023 and last updated 17th of the same month. Nevertheless, there are still a multitude of other trials that currently require applicants for their research initiatives."
Answered by AI
What type of participants are eligible for this clinical experiment?
"Aspiring participants of this study must be in the premenopausal stage and between 38-45 years old. This research is accepting 50 individuals total."
Answered by AI
Does the age requirement for this trial extend beyond 60 years of age?
"The requirements for enrolment in this clinical trial specifies that participants must be between 38 and 45 years old."
Answered by AI
Does Rapamycin present any potential health hazards for individuals?
"Power's safety rating for rapamycin is 2, as the drug has been studied in Phase 2 trials. Meaning, there are data points that suggest it can be safely administered but no evidence of efficacy yet."
Answered by AI
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