NCT05836025

Effect of Rapamycin in Ovarian Aging

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: Female
• Age: 35 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Perimenopausal

Interventions

Type	Name	Description
DRUG	Rapamycin	5mg/week of rapamycin orally for 12 weeks
OTHER	Placebo	5mg/week of placebo orally for 12 weeks

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-10-21
• Completion: 2026-09-01
• First posted: 2023-05-01
• Last updated: 2025-12-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study