Clinical Trial 55390

West Palm Beach, FL 33409


Summary:

A Phase IV, Longitudinal, Observational Study Examining Real-world Outcomes of Non-hormonal Pharmacotherapies among Individuals Treated for Bothersome Vasomotor Symptoms (hot flashes). 

This observational study will assess the change from baseline in VMS bother (in all participants and by specified sub-groups) of participants initiating non-hormonal therapy (non-HT), including NK3-R antagonists, for the treatment of VMS (stratified by treatment class) in the real-world setting. Primary Research Question: Is there a change from baseline in VMS bother experienced by individuals initiating non-HT for the treatment of VMS?

This is a longitudinal, multi-center, observational study following participants with a confirmed diagnosis of VMS and a decision to prescribe a non-HT option has been made by the treating health care provider. Participants will be on study for 1 year following initiation of a new course of treatment with a non-hormonal medication for the treatment of VMS. The study will assess the change in symptom bother (in all participants and by specified sub-groups) from the baseline of participants initiating non-HT, including fezolinetant, for the treatment of VMS in the real-world setting. 



Inclusion Criteria:

1. Informed consent must be obtained from the participant prior to any study-related procedures.

2. Participant assigned female at birth aged 40 through 75 years, inclusive, at the time of initial presentation with VMS.

3. Participant must be willing to comply with digital tools and applications.

4. Participant is diagnosed with bothersome VMS due to/associated with menopause for at least 3 months based on standard of care assessment captured in consultation with an HCP including the participant’s history, routine physical examination, and routine laboratory assessments (when applicable).

5. HCP has made the clinical decision to begin pharmacologic treatment with a non-HT including, a selective NK3-R antagonist, an SSRI, SNRI, gabapentin, clonidine, pregabalin, oxybutynin or other non-HT, as part of the standard treatment for VMS. This may be the first course of treatment, a restart or a switch from one drug to another. A restart or switch of a previous therapy requires a minimum of a 10-day period not on therapy/washout period.

6. Participant’s health status is stable as determined by the HCP based on their medical history and general physical exam and determined to be a candidate for treatment with non-HTs.

7. If participant has been prescribed an SSRI or SNRI for the treatment of depression or anxiety, they must be on a stable or consistent dose for a minimum of 3 months.

8. Participant has a negative urine pregnancy test at screening if not post-menopausal

9. Only for participants utilizing complementary and alternative therapies, mind-body techniques, or supplements for the treatment of VMS: participant has been on such therapies for ≥ 3 months and intends to continue through duration of study.


Qualified Participants May Receive:

Study related tests, studies, scans, blood work, exams, and compensation for time and travel.


Available At:

Comprehensive Clinical Research
603 Village blvd
suite 301
west palm beach, FL 33409
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Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.