PerimenopausalPhase 2RapamycinNCT05836025
Effect of Rapamycin in Ovarian Aging
A Phase 2 study testing Rapamycin in people with Perimenopausal, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Perimenopausal
- What is being tested?
- Rapamycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York, 10032
About this study
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.
Read the 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.
- Conditions
- Perimenopausal
- Being tested
- Rapamycin, Placebo
- Keywords
- Premenopausal, Perimenopause, Fertility, Women's health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapamycinDrug
5mg/week of rapamycin orally for 12 weeks
PlaceboOther
5mg/week of placebo orally for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rapamycin | Experimental | Participants randomized to the treatment arm will receive 5mg/week of rapamycin orally, for 12 weeks (3 months). Receives: Drug: Rapamycin |
| Placebo | Placebo comparator | Participants randomized to the placebo arm will receive placebo orally, for 12 weeks (3 months). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Ovarian Reserve
Ovarian reserve will be determined using AMH
Measured: Up to 1 year
Secondary outcomes (4)
TVU
TVUs will be used to measure follicle growth
Measured: Up to 1 year
Estradiol (E2) Level
Estradiol levels will be measured.
Measured: Day 21 of menstrual cycle
FSH Level
Follicle stimulating hormone (FSH) levels will be measured.
Measured: Day 21 of menstrual cycle
Klotho Level
Klotho levels will be measured.
Measured: Day 21 of menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Jun 2023
- Primary completion21 Oct 2025
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopausalStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Zev Williams, Columbia University
- Investigators
- Samuel Z. Williams, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836025
- Sponsor's protocol ID
- AAAU1074
- Acronym
- Rapamycin
- Status last verified
- Dec 2025
- First submitted
- 17 Apr 2023
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rapamycin in Ovarian Aging
- ClinicalTrials.gov ID
- NCT05836025
- Acronym / sponsor ID
- Rapamycin / AAAU1074
- Conditions
- Perimenopausal
- Keywords
- Premenopausal, Perimenopause, Fertility, Women's health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 21 Oct 2025 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapamycin | Experimental | Drug: RapamycinParticipants randomized to the treatment arm will receive 5mg/week of rapamycin orally, for 12 weeks (3 months). |
| Placebo | Placebo comparator | Other: PlaceboParticipants randomized to the placebo arm will receive placebo orally, for 12 weeks (3 months). |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapamycin5mg/week of rapamycin orally for 12 weeks | Drug | Rapamycin |
| Placebo5mg/week of placebo orally for 12 weeks | Other | Placebo |
Primary outcome
Measure of Ovarian Reserve
Time frame: Up to 1 year
Ovarian reserve will be determined using AMH
4 secondary outcomes
TVU
Time frame: Up to 1 year
Estradiol (E2) Level
Time frame: Day 21 of menstrual cycle
FSH Level
Time frame: Day 21 of menstrual cycle
Klotho Level
Time frame: Day 21 of menstrual cycle
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Z. Williams, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rapamycin in people with Perimenopausal, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of Ovarian Reserve (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.