Status:
COMPLETED
Dose-ranging, PK, Safety, Efficacy Study of Osanetant in Patients With Moderate/Severe VMS Associated With Menopause
Lead Sponsor:
Acer Therapeutics Inc.
Conditions:
Post-menopausal Vasomotor Symptoms
Eligibility:
FEMALE
40-65 years
Phase:
PHASE1
PHASE2
Brief Summary
In this clinical research study, subjects will be given the study drug, ACER-801 (osanetant) or placebo (looks like the study drug but contains no active ingredients). The study drug works on a recept...
Detailed Description
This is a Phase 2a, randomized, double-blind, placebo-controlled, dose-ranging study in post menopausal women in which the pharmacokinetics, safety and efficacy of ACER-801 (osanetant 50 mg twice dail...
Eligibility Criteria
Inclusion
- Key
- Post-menopausal female subjects 40-65 years of age, inclusive.
- Menopause will be defined as:
- At least 12 months of spontaneous, continuous amenorrhea, or
- At least 6 months of spontaneous, continuous amenorrhea with serum follicle stimulating hormone (FSH) levels \> 40 mIU/mL at screening, or
- At least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- At baseline women:
- With an average number of moderate to severe hot flashes/day for 2 weeks prior to randomization (per continuous hot flash diary).
- That have a change of \< 50% in average 24-hour hot flash frequency 2 weeks prior to randomization.
- Moderate: defined as sensation of heat with sweating, able to continue activity.
- Severe: defined as sensation of heat with sweating, causing cessation of activity.
- Key
Exclusion
- Any active comorbid disease deemed by the investigator to be clinically significant, which could impact safety during study conduct including renal or hepatic impairment.
- Use of any prohibited medications.
- Body mass index (BMI) \>35 kg/m2.
- Any active ongoing condition that could cause difficulty in interpreting vasomotor symptoms.
- Inability to complete questionnaires and continuous hot flash diary for any reason.
- Subjects who, in the opinion of the investigator, should not participate in the study for any other reason.
Key Trial Info
Start Date :
March 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2023
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT05325775
Start Date
March 30 2022
End Date
March 4 2023
Last Update
August 7 2024
Active Locations (1)
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1
Spaulding Clinical Research
West Bend, Wisconsin, United States, 53095