Focusing on the Menopausal Transition to Improve Mid-Life Women's Health

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

October 31, 2029

Study Completion Date

October 1, 2030

Conditions
MenopauseMenopause Hot FlashesMenopause Related ConditionsCardiovascular
Interventions
DRUG

Metformin

Metformin will be given to participants who have a elevated HbA1c and also for weightloss.

DRUG

semaglutide

Overweight women and women with obesity will take Semaglutide for weight-loss

DRUG

Anti-hypertensives

a. Antihypertensives, with the goal of maintaining blood pressure at 130/80 or lower per ACC guidelines19. Per current clinical guidelines and standard of care, hypertension will be treated first with monotherapy using either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), a calcium channel blocker, or a thiazide diuretic provided that are no contraindications.

DRUG

Lipid Lowering Medication

. First line agents will be generic statin medications (atorvastatin or rosuvastatin)whichever is covered by the participant's health insurance), barring contraindication to their use.

BEHAVIORAL

Life style intervention

will simply be followed and given preventive advice (maintenance of a normal BMI and physical activity, moderation in salt intake, and no more than 1 alcoholic drink per day). They will be provided with a wearable activity monitor. This advice will be based on guidelines by the American Heart Association and the Menopause Society.

DRUG

Fezolinetant

Women with menopausal symptoms will be treated with hormone therapy (estrogen and progesterone) if appropriate, or with a neurokinin receptor antagonist (Fezolinetant). This can be treatment for women in any arm of the study as well as an arm by its self.

DRUG

Hormonal therapy

Participants will be treated with estrogen and/or progesterone for treatment of hot flashes in women during the study.

Trial Locations (1)

80045

University of Colorado-School of Medicine, Aurora

All Listed Sponsors
lead

University of Colorado, Denver

OTHER