Menopause Clinical Trials

Find Menopause Clinical Trials Near You

The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity: A Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The purpose of this study is to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 46
Maximum Age: 60
Healthy Volunteers: t
View:

• Postmenopausal women defined as 12 months of spontaneous amenorrhea, or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels \> 40 mIU/ml, or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.

• Age 46-60 years old.

• BMI ≥30 kg/m2 or BMI ≥27 kg/m2 in the presence of adiposity-associated diseases (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease).

• Presence of bothersome hot flashes (≥ 28 episodes per week and of sufficient severity to prompt patients to seek therapeutic interventions).

• Hot flashes must be present for \>30 days prior to study entry.

• Ability to participate in all portions of the study, including willingness to self-inject drug

• Provided informed consent to be part of the study.

• Willingness and capability to follow a hypocaloric diet, consisting of an energy deficit of approximately 500 kcal/day compared to baseline total energy expenditure, and composed of 30% from fat, 20% from protein, and 50% of carbohydrate. In addition to performing at least 150 min/week of physical activity

Locations
United States
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
Contact Information
Primary
Tina Taaffe
taaffe.christina@mayo.edu
904-953-4769
Backup
Lauren Uy
uy.lauren@mayo.edu
904-953-5337
Time Frame
Start Date: 2026-04-08
Estimated Completion Date: 2027-09-18
Participants
Target number of participants: 40
Treatments
Experimental: Tirzepatide
Participants will receive tirzepatide for 24 weeks, in addition to standard lifestyle modification recommendations
Placebo_comparator: Placebo
Participants will receive a placebo for 24 weeks, in addition to standard lifestyle modification recommendations
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov

Similar Clinical Trials