ACTIVE_NOT_RECRUITING

Effect of Rapamycin in Ovarian Aging

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators are proposing a prospective, randomized, double-blind, placebo-controlled pilot study assessing the ability of low-dose rapamycin to delay ovarian aging in women. Animal studies have shown the potential of rapamycin in slowing or reversing some age-associated pathways.

Official Title

Effect of Rapamycin in Ovarian Aging

Quick Facts

Study Start:2023-06-01
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05836025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women aged 35-45 years
  2. * In the menopausal transition stage -3a
  3. * Have been unable to conceive based on diminished ovarian reserve and who have failed to develop any euploid embryos with IVF or who do not desire to conceive within the next 1.5 years
  4. * Have regular menstrual periods (with less than 7 days of variability)
  5. * Early follicular phase follicle stimulating hormone (FSH) levels \] \< 20 mIU/mL
  6. * Anti-müllerian hormone (AMH) levels of \>0.1 ng/mL
  7. * Antral Follicle Counts (AFC) of \>3
  1. * Women with irregular menstrual cycles
  2. * Severe ovarian deficiency, or with no evidence of remaining follicles
  3. * Kidney or liver disease
  4. * Any significant medical disease, including cancer
  5. * Contraindications to receiving rapamycin

Contacts and Locations

Principal Investigator

Samuel Z. Williams, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Samuel Z. Williams, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-01
Study Completion Date2026-09

Study Record Updates

Study Start Date2023-06-01
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • Premenopausal
  • Perimenopause
  • Fertility
  • Women's health

Additional Relevant MeSH Terms

  • Perimenopausal