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Search / Trial NCT06975111

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

Launched by UNIVERSITY OF COLORADO, DENVER · May 7, 2025

Trial Information

Current as of July 23, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring how certain health interventions can help women aged 45-55 who are going through the menopausal transition. As women enter menopause, they may face an increased risk of heart and metabolic issues, along with uncomfortable symptoms like hot flashes. The researchers aim to see if evidence-based strategies can reduce inflammation, improve heart health, and lessen these bothersome symptoms, ultimately enhancing the quality of life for women during this stage.

To participate in the study, women need to be between 45 and 55 years old and in the late stages of menopause, which means they haven't had a period for about two months but less than a year. They should not be using hormone therapy or contraception, must have a uterus and at least one ovary, and have access to a smartphone and reliable internet for telehealth appointments. Participants can expect to engage in health interventions and provide feedback through electronic surveys. It’s important to note that the trial is not yet recruiting participants, so there’s no immediate need to apply.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • aged 45-55
  • In the late menopausal transition, defined as 60 days of amenorrhea but less than 365 days of amenorrhea18
  • No current use of hormone therapy or hormonal contraception
  • Presence of a uterus and at least one ovary in order to track menstrual patterns
  • Have a smartphone and broadband access adequate to accept telehealth appointments
  • Exclusion Criteria:
  • Lack of broadband access (activity and survey data will be collected electronically whenever possible and some visits will be via telehealth)
  • Lack of regular menstrual periods in mid-reproductive life (ages 25-38) when not on hormones or not pregnant.
  • Pregnancy or actively trying to get pregnant
  • Inability to adhere to study protocol schedule
  • Untreated alcoholism
  • Un- Diagnosed abnormal uterine bleeding
  • Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (MEN 2) for participants with a BMI\> 30 kg/m2.

About University Of Colorado, Denver

The University of Colorado, Denver, is a leading academic institution dedicated to advancing medical research and improving healthcare outcomes. With a strong emphasis on innovation and collaboration, the university conducts a diverse range of clinical trials aimed at addressing critical health challenges. Its research initiatives are supported by a multidisciplinary team of experts, state-of-the-art facilities, and a commitment to ethical standards and patient safety. By fostering partnerships with local and global communities, the University of Colorado, Denver, strives to translate scientific discoveries into meaningful advancements in clinical practice and public health.

Locations

Aurora, Colorado, United States

Patients applied

0 patients applied

Trial Officials

Nanette Santoro, MD

Principal Investigator

University of Colorado, Denver

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported