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Effect of Rapamycin in Ovarian Aging (Rapamycin)

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ClinicalTrials.gov Identifier: NCT05836025
Recruitment Status : Recruiting
First Posted : May 1, 2023
Last Update Posted : May 8, 2024
Sponsor:
Information provided by (Responsible Party):
Samuel Zev Williams, Columbia University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Perimenopausal Drug: Rapamycin Other: Placebo Phase 2

Detailed Description:

One of the earliest and most profound changes associated with human aging is the rapid decline in ovarian follicular activity and reproductive capacity. Beginning around age 35, fertility rates decline as the number and quality of oocytes fall, culminating in the onset of menopause around age 51. The onset of menopause has profound socioeconomic, quality of life, and health implications, including increasing the risks of cardiovascular disease, osteoporosis, cognitive decline and dementia. While human lifespan has increased, the age of menopause has remained largely unchanged, leaving more women living an ever-larger proportion of their lives in a postmenopausal state. The narrow reproductive window adds socioeconomic pressure on women to complete childbearing within a limited timeframe, or preserve their fertility with egg or embryo freezing. The investigators and others have demonstrated that rapamycin can delay ovarian aging in mice.

The purpose of this pilot study is to determine whether the same may be true in humans. Extending the reproductive lifespan will reduce the time pressure on women to complete childbearing and will allow more women to spend more of their lives in the premenopausal status and delay the negative healthy consequences of menopause.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Rapamycin in Ovarian Aging
Actual Study Start Date : June 1, 2023
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Rapamycin
Participants randomized to the treatment arm will receive 5mg/week of rapamycin orally, for 12 weeks (3 months).
 Drug: Rapamycin
5mg/week of rapamycin orally for 12 weeks
Placebo Comparator: Placebo
Participants randomized to the placebo arm will receive placebo orally, for 12 weeks (3 months).
 Other: Placebo
5mg/week of placebo orally for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Measure of Ovarian Reserve [ Time Frame: Up to 1 year ]
    Ovarian reserve will be determined using AMH


Secondary Outcome Measures :
  1. TVU [ Time Frame: Up to 1 year ]
    TVUs will be used to measure follicle growth

  2. Estradiol (E2) Level [ Time Frame: Day 21 of menstrual cycle ]
    Estradiol levels will be measured.

  3. FSH Level [ Time Frame: Day 21 of menstrual cycle ]
    Follicle stimulating hormone (FSH) levels will be measured.

  4. Klotho Level [ Time Frame: Day 21 of menstrual cycle ]
    Klotho levels will be measured.


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women aged 35-45 years
  • In the menopausal transition stage -3a
  • 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
  • Have regular menstrual periods (with less than 7 days of variability)
  • Early follicular phase follicle stimulating hormone (FSH) levels ] < 20 mIU/mL
  • Anti-müllerian hormone (AMH) levels of >0.1 ng/mL
  • Antral Follicle Counts (AFC) of >3

Exclusion Criteria:

  • Women with irregular menstrual cycles
  • Severe ovarian deficiency, or with no evidence of remaining follicles
  • Kidney or liver disease
  • Any significant medical disease, including cancer
  • Contraindications to receiving rapamycin
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05836025


Contacts
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Contact: Stephanie Morgan 212-314-8837 sm3415@cumc.columbia.edu

Locations
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United States, New York
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Samuel Z. Williams, MD Columbia University
More Information
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Responsible Party: Samuel Zev Williams, Associate Professor of Obstetrics and Gynecology, Columbia University
ClinicalTrials.gov Identifier: NCT05836025    
Other Study ID Numbers: AAAU1074
First Posted: May 1, 2023    Key Record Dates
Last Update Posted: May 8, 2024
Last Verified: May 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Samuel Zev Williams, Columbia University:
Premenopausal
Perimenopause
Fertility
Women's health
Additional relevant MeSH terms:
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Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
 Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs