Effect of Rapamycin in Ovarian Aging

NCT05836025 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: AAAU1074
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Perimenopausal

Keywords

Premenopausal; Perimenopause; Fertility; Women's health

Outcome Measures

Primary Outcomes (1)

• Measure of Ovarian Reserve

  Ovarian reserve will be determined using AMH

  Up to 1 year

Secondary Outcomes (4)

• TVU

  Up to 1 year

• Estradiol (E2) Level

  Day 21 of menstrual cycle

• FSH Level

  Day 21 of menstrual cycle

• Klotho Level

  Day 21 of menstrual cycle

Study Arms (2)

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

Rapamycin DRUG

5mg/week of rapamycin orally for 12 weeks

Rapamycin

Placebo OTHER

5mg/week of placebo orally for 12 weeks

Placebo

Eligibility Criteria

• Age: 35 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Samuel Z. Williams, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 1, 2023
• Study Start: June 1, 2023
• Primary Completion: October 21, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

US (1)