What side effects are associated with this type of intervention?

Common treatments for perimenopause include hormone therapy (HT) with estrogen and progestin, SSRIs/SNRIs, and high-dose progestogens. Known side effects of HT can include an increased risk of coronary heart disease, invasive breast cancer, stroke, and pulmonary embolism. SSRIs/SNRIs may cause nausea, dizziness, weight gain, and sexual dysfunction. High-dose progestogens can lead to weight gain, mood changes, and potential cardiovascular risks. These treatments aim to alleviate symptoms but come with varying degrees of risk that should be discussed with a healthcare provider.

What prior FDA approvals exist?

FDA-approved treatments for perimenopause primarily include hormonal therapies such as estrogen and progestin, which are effective in managing symptoms like hot flashes and vaginal dryness. Non-hormonal options include SSRIs and SNRIs like paroxetine and venlafaxine, which are used to alleviate hot flashes. While low-dose rapamycin is being studied for its potential to modulate age-associated pathways, it is not yet approved for perimenopausal treatment. Current approved treatments do not specifically target the same pathways as rapamycin but focus on symptom relief through hormonal and neurotransmitter modulation.

What other types of research exist?

Promising alternatives to low-dose rapamycin for perimenopause patients include mTOR inhibitors like everolimus, which have shown efficacy in various age-related conditions. Additionally, lifestyle interventions such as weight management and exercise, as well as hormone replacement therapy (HRT), remain important considerations. Emerging therapies targeting the AKT-mTOR pathway and other molecular mechanisms involved in aging may also offer potential benefits.

← Back to Search

Rapamycin for Perimenopause (Rapamycin Trial)

Phase 2

Recruiting

Led By Samuel Z. Williams, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Summary

This trial is testing whether a small dose of rapamycin can delay ovarian aging in women. Rapamycin has shown potential for preserving ovarian health, but using it for an extended period can have negative effects. The goal is to extend the time women remain fertile and delay menopause. This could reduce health risks and improve quality of life for women as they age.

Who is the study for?

This trial is for women aged 38-45 in the early stages of menopause, who have struggled with fertility due to diminished ovarian reserve. They should still have regular menstrual cycles and specific hormone levels within a set range. It's not suitable for those outside this age group or stage of menopause.

What is being tested?

The study tests if low-dose Rapamycin can delay the process of ovarian aging compared to a placebo. Participants won't know which one they're getting as it's a double-blind study, meaning neither the participants nor the researchers know who receives Rapamycin or placebo until after the results are collected.

What are the potential side effects?

While side effects aren't detailed here, Rapamycin may commonly cause mouth sores, diarrhea, nausea, and skin issues like acne or rash. More serious but less common risks include lung problems and increased susceptibility to infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure of Ovarian Reserve

Secondary study objectives

Estradiol (E2) Level

FSH Level

Klotho Level

+1 more

Side effects data

From 2009 Phase 4 trial • 20 Patients • NCT00223678

31%

pneumonia

15%

acute kidney failure

dehydration

hip replacement

acute rejection

total abdominal hysterectomy and salpingectomy

anemia

100%

80%

60%

40%

20%

Study treatment Arm

Rapamycin Group

CNI Group

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RapamycinExperimental Treatment1 Intervention

Participants randomized to the treatment arm will receive 5mg/week of rapamycin orally, for 12 weeks (3 months).

Group II: PlaceboPlacebo Group1 Intervention

Participants randomized to the placebo arm will receive placebo orally, for 12 weeks (3 months).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rapamycin

2008

Completed Phase 4

~1200

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for perimenopause primarily involve hormonal therapies, such as estrogen and progestin, which help stabilize fluctuating hormone levels to alleviate symptoms like hot flashes and mood swings. These treatments work by compensating for the body's decreased hormone production. Additionally, investigational treatments like low-dose rapamycin target age-associated pathways, specifically the mTOR pathway, which is involved in cellular aging and metabolism. This dual approach not only provides symptomatic relief but also addresses underlying aging processes, potentially offering broader health benefits for perimenopause patients.

Considerations in the choice of oral vs. transdermal hormone therapy: a review.