A Study of NOE-115 in Women With Vasomotor Symptoms Due to Menopause (NCT06385795) | Clinical Trial Compass
CompletedPhase 2
A Study of NOE-115 in Women With Vasomotor Symptoms Due to Menopause
United States40 participantsStarted 2024-04-22
Plain-language summary
The purpose of this study is to determine the safety, tolerability, and preliminary effectiveness of NOE-115 on moderate to severe vasomotor symptoms (hot flashes) due to menopause in women.
Who can participate
Age range45 Years – 60 Years
SexFEMALE
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Inclusion Criteria:
* Capable of giving signed informed consent as described in study protocol which includes compliance with the requirements and restrictions listed in the Informed Consent Form.
* Female 45 years to 60 years of age inclusive, at the time of signing the Informed Consent Form
* Women who have experienced changes in menstrual cycle frequency or duration, and/or symptoms that are indicative of menopausal transition, as determined by the investigator
* Greene climacteric scale (GCS) total score \> 20 and GCS subscore for VMS ≥ 3
* Over the 10 days prior to enrolment (during the Screening Period), subject has a minimum of 7 to 8 moderate to severe hot flashes (VMS) per day, or 50 to 60 per week
* Body weight \> 50 kg; Body Mass Index (BMI) within the range 17.5 to 40.0 kg/m2 (inclusive)
Exclusion Criteria:
* Clinically overt alcohol or drug use disorder (including use of cannabis/cannabinoids within 4 weeks prior to Screening).
* History of psychiatric diagnoses (schizophrenia, schizoaffective, obsessive-compulsive disorder, bipolar disorder, or Attention Deficit/hyperactivity Disorder(ADHD)
* Current episode of major depression with Hamilton Rating Scale for Depression (HAM-D-17) score ≥ 17 \[to be calculated as a subscore of the Structured interview guide for the Hamilton depression scale with atypical depression supplement \[SIGH-ADS\]
* Prior or current history of a malignant tumor, except for basal cell carcinoma in remission
* Participants with a current…
What they're measuring
1
Withdrawals Due to Adverse Events While on NOE-115 for Any Reason