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Can a Low-Dose drug delay menopause? new trial aims to find out

NCT ID NCT05836025

Disease control Sponsor: Columbia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tests whether low-dose rapamycin can slow ovarian aging in 50 women aged 35-45 who are in early perimenopause. Participants take 5mg of rapamycin or a placebo weekly for 12 weeks. Researchers will measure hormone levels and ovarian reserve to see if the drug delays age-related decline.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rapamycin (low dose, 5mg/week for 12 weeks)
What this could lead to
If it works, this could point toward a way to slow ovarian aging and extend fertility in perimenopausal women.
What could go wrong
This is a small, early-phase pilot study with only 50 participants. Results may not apply to all women, and the effect on fertility is not directly tested.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

50 people

The number who actually took part.

Started

Jun 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Perimenopausal

Contacts and locations

Locations

  • Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

    New York, New York, 10032, United States