Status:
ACTIVE_NOT_RECRUITING
A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
Lead Sponsor:
Astellas Pharma Global Development, Inc.
Conditions:
Hot Flashes
Eligibility:
FEMALE
40-75 years
Brief Summary
Hot flashes and night sweats (also known as vasomotor symptoms or VMS) are the most common symptoms which bother women in menopause. This study will follow women going through menopause who have hot f...
Eligibility Criteria
Inclusion
- Participant is diagnosed with bothersome VMS due to/associated with menopause for at least 3 months based on a standard of care assessment captured in consultation with an HCP including the participant's history, routine physical examination, and routine laboratory assessments.
- HCP has made the clinical decision to begin pharmacologic treatment with a non-HT including, a selective neurokinin 3 receptor (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 (HT/non- HT) to another non-HT. A restart or switch of a previous therapy requires a minimum of a 10-day period not on therapy/washout period prior to pre-baseline.
- Participant's health status is stable based on their medical history and general physical exam and determined to be a candidate for treatment with non-HTs.
- 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 prior to screening.
- Participant has a negative urine pregnancy test at screening if not post-menopausal.
- 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 prior to screening and intends to continue through duration of study.
- Confirmation has been made that the participant is able to obtain the prescribed non hormonal therapy (e.g., insurance coverage verified, participant has ability to self pay, or patient support program activated for at least 12 months for the uninsured participants, if applicable).
Exclusion
- Participant is currently enrolled in any interventional or non-interventional wearable device study.
- Participant has any condition which makes the participant unsuitable for the study.
- Participant has a contraindication to the non-HT they are being prescribed for the treatment of VMS.
- Participant is currently taking hormonal contraceptives or other systemic HTs (including estrogen and/or progesterone, and/or testosterone preparations) and has not had a 10-day washout period prior to pre-baseline (vaginal/local estrogen preparations and levonorgestrel-releasing intrauterine system are not prohibited).
- Participant has presence of moderately severe or severe depression per standard of care assessment utilizing a standardized depression screening tool.
- Participant is currently pregnant or planning to become pregnant.
- Participant is post-menopausal and has a history of unexplained uterine bleeding within the last 6 months.
- Participant has pre-existing uncontrolled thyroid disease.
- Participant has unstable angina or participant has uncontrolled hypertension based on a standard of care assessment.
- Participants who do not meet these criteria may be re-assessed after initiation or review of antihypertensive measures.
- Participants with a medical history of hypertension can be enrolled once they are medically clear (stable and compliant).
- Participant has had insomnia unrelated to either menopause or bothersome VMS due to/associated with menopause.
- Participant has known substance abuse or alcohol addiction within 6 months of screening.
- Participant has been on intramuscular estradiol within 8 weeks of screening.
- Participant has a current diagnosis of a malignancy or history of a malignancy within the past 2 years (This does not include basal cell carcinoma or breast cancer.)
- Participants with metastatic (Stage 4) breast cancer.
- Participants who have been prescribed adjuvant endocrine therapy (tamoxifen or aromatase inhibitors with or without gonadotropin-releasing hormone analogues) for their non-metastatic (stage 0 to 3) breast cancer but have not maintained a stable treatment regimen for at least 3 months prior to screening.
- Participant has initiated hormone pellet therapy within 6 months of screening.
Key Trial Info
Start Date :
November 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2026
Estimated Enrollment :
999 Patients enrolled
Trial Details
Trial ID
NCT06049797
Start Date
November 15 2023
End Date
May 31 2026
Last Update
January 6 2026
Active Locations (48)
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1
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35205
2
Accel Research Sites-Cahaba Medical Care-OBGYN
Birmingham, Alabama, United States, 35218
3
Precision Trials AZ, LLC
Phoenix, Arizona, United States, 85032
4
Torrance Clinical Research Institute,Inc
Lomita, California, United States, 90717