Status and phase
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About
The purpose of the study is to determine the efficacy of FP-101 versus placebo for the treatment of hot flashes in postmenopausal women.
Full description
Vasomotor symptoms, commonly known as hot flashes or hot flushes, are the most common symptoms experienced by women who are perimenopausal or postmenopausal. FP-101 is postulated to mediate one of the mechanisms thought to drive hot flashes in post-menopausal women. This study will evaluate the efficacy and safety of FP-101 for the treatment of hot flashes in post-menopausal women.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Subjects may be enrolled in the main study only if they meet all of the following criteria:
Subject must be a female >40 years of age at screening.
Subject must have reported more than 7 to 8 moderate-to-severe hot flashes per day or 50 to 60 hot flashes per week for at least 30 days prior to the Screening Visit of sufficient severity to cause desire for therapeutic intervention.
Subject must meet 1 of the following criteria:
A subject who is not at least 2 years postmenopausal must use adequate nonhormonal contraception (eg, barrier methods such as an intrauterine device, diaphragm, cervical cap, or condom) during study participation.
Subject must be willing and able to be compliant with the protocol and provide a voluntary written informed consent.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
109 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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