Study to Evaluate the Safety and Efficacy of RAD1901 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms
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The objectives of this study are to determine the safety and efficacy of RAD1901 in postmenopausal women with moderate to severe VMS as assessed by a reduction from baseline in the frequency and severity of hot flashes [ Time Frame: 12 Weeks ]
Secondary Outcome Measures :
Change from baseline in the severity of hot flashes at 4 and 12 weeks [ Time Frame: 4 and 12 weeks ]
Change from baseline in the frequency of moderate to severe hot flashes at 4 weeks [ Time Frame: 4 weeks ]
Change from baseline in the frequency of mild, moderate, and severe hot flashes at 4 and 12 weeks by eDiary [ Time Frame: 4 and 12 weeks ]
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Ages Eligible for Study:
40 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
To participate in this study, a subject MUST:
be a postmenopausal woman between 40 and 65 years of age, inclusive
be seeking relief or treatment for moderate to severe VMS
be willing to discontinue and abstain from the following: vaginal hormonal products; transdermal or oral estrogen or estrogen/progestin combination; progestin implants; injectable estrogen; topical progesterone cream, selective estrogen receptor modulators [e.g., ospemifene, raloxifene, tamoxifen, Duavee® (conjugated estrogens and bazedoxifene) and intrauterine devices (IUDs)]
have a normal or clinically insignificant transvaginal ultrasound (TVU)
have a normal endometrial biopsy subsequent to the TVU without clinically relevant results
have a normal screening Papanicolaou (Pap) smear
have a mammogram within 9 months prior to randomization. Subjects must have a Breast Imaging Reporting and Data System (BI-RADS) mammography result of 1 or 2 to enroll.
Subjects with any of the following characteristics will not be eligible to participate in the study:
have a history of invasive breast cancer or ductal carcinoma in situ, melanoma or any gynecologic cancer.
using any of the following:
oral estrogen-, progestin-, androgen-, or selective estrogen receptor modulator containing drug products within 8 weeks before screening (visit 1)
transdermal hormone products within 4 weeks before screening (visit 1)
vaginal hormone products (rings, creams, gels) within 4 weeks before screening (visit 1)
progestin implants/injectables, IUDs or estrogen pellets/injectables within 6 months before screening (visit 1)
have been treated with a GnRH agonist within the last year
have been treated with anti-estrogens, or aromatase inhibitors within 2 months prior to study entry
have been concurrently treated and will abstain from gabapentin and paroxetine or serotonin and norepinephrine reuptake inhibitors (SNRIs) for VMS or other indications for 3 months during the trial and have not taken within 4 weeks prior to screening
have an endometrial biopsy at baseline with a diagnosis by a gynecologic pathologist of proliferative, hyperplasia, polyp or cancer
unresolved findings suspicious for malignancy on the breast examination