Study to Evaluate the Safety and Efficacy of RAD1901 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms
Condition: Vasomotor Symptoms; Hot Flashes
MeSH terms: Hot Flashes
Intervention: RAD1901; Placebo
Intervention description: RAD1901; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 139.0
Sex: Female
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of this study was to determine the clinical safety of RAD1901 and to
      evaluate whether RAD1901 reduced the frequency and severity of moderate to severe vasomotor
      symptoms (VMS; "hot flashes") in postmenopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

        To have participated in this study, a subject MUST:

          1. be a postmenopausal woman between 40 and 65 years of age, inclusive

          2. be seeking relief or treatment for moderate to severe VMS

          3. 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 and intrauterine devices (IUDs)

          4. have no clinically significant abnormalities on pelvic exam except for vulvovaginal
             atrophy (VVA)

          5. have a normal or clinically insignificant transvaginal ultrasound (TVU) with an
             endometrial thickness <4 mm at screening

          6. have a normal endometrial biopsy subsequent to the TVU without clinically relevant
             results

          7. have a normal screening Papanicolaou (Pap) smear

          8. have a mammogram within 9 months prior to randomization. Subjects must have had a
             Breast Imaging Reporting and Data System (BI-RADS) mammography result of 1 or 2 to
             enroll.

        Exclusion Criteria:

        Subjects with any of the following characteristics were not be eligible to participate in
        the study:

          1. have a history of invasive breast cancer or ductal carcinoma in situ, melanoma or any
             gynecologic cancer.

          2. using any of the following:

               -  oral estrogen-, progestin-, androgen-, or selective estrogen receptor modulator
                  (SERM) 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)

               -  anabolic steroids

          3. have been treated with a gonadotropin-releasing hormone (GnRH) agonist within the last
             year

          4. have been treated with anti-estrogens or aromatase inhibitors within 2 months prior to
             study entry

          5. 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

          6. have unexplained vaginal bleeding within the 3 months prior to study entry

          7. have an endometrial biopsy at baseline with a diagnosis by a gynecologic pathologist
             of proliferative, hyperplasia, polyp or cancer

          8. have unresolved cervical cytological smear report of atypical glandular or squamous
             cells of undetermined significance. Cervical cytologic smear report of ASCUS, low
             grade squamous intraepithelial lesion or greater, or any reported dysplasia

          9. have unresolved findings suspicious for malignancy on the breast examination