Effect of Rapamycin in Ovarian Aging | NCT05836025

Studies
Effect of Rapamycin in Ovarian Aging

NCT05836025

Sponsor

Columbia University

Status

Active, not recruiting

Last Update Posted

Dec 26, 2025Actual

Enrollment

50Actual

Phase

Phase 2

Conditions

Perimenopausal

Interventions

Rapamycin
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

Oct 21, 2025Actual

Completion Date

Sep 2026Estimated

First Submitted Date

Apr 17, 2023

First Submission Date that Met QC Criteria

Apr 17, 2023

First Posted Date

May 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2025

Last Update Posted Date

Dec 26, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Samuel Zev Williams, Associate Professor of Obstetrics and Gynecology, Columbia UniversityPrincipal Investigator

Lead Sponsor

Columbia UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rapamycin	Drug	5mg/week of rapamycin orally for 12 weeks	Rapamycin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure of Ovarian Reserve	Ovarian reserve will be determined using AMH	Up to 1 year

Secondary Outcomes

Measure	Description	Time Frame
TVU	TVUs will be used to measure follicle growth	Up to 1 year
Estradiol (E2) Level	Estradiol levels will be measured.	Day 21 of menstrual cycle

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Samuel Z. Williams, MD	Columbia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital		New York	New York	10032	United States

Intervention Browse Module

MeSH Terms

ID	Term
D020123	Sirolimus

Ancestor Terms

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

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