The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age46-60
SponsorMayo Clinic
About this trial
The purpose of this study is to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging.
Eligibility criteria
Qualifiers
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).
Disqualifiers
Current treatment with menopausal hormone therapy.
Estrogen-containing contraceptive methods or menopausal hormone therapy (oral, transdermal, high dose vaginal ring, injection, pellets).
Vaginal estrogen.
Androgens.
Trial design
Treatments tested in this trial
- Tirzepatide
- Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov