Efficacy and Safety of S-equol on Vasomotor Symptoms in Menopausal Patients
Condition: Menopause
Intervention: Placebo; S-equol
Intervention description: Eligible patients meeting all study entry criteria were randomly assigned to receive one of the following active treatments for 4 weeks:
S-equol 10 mg BID (20 mg total daily dose)
S-equol 50 mg BID (100 mg total daily dose)
S-equol 150 mg BID (300 mg total daily dose)
Intervention MeSH terms: Equol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 169.0
Sex: Female
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and effectiveness of S-equol in menopausal
      patients with hot flushes and night sweats.
    

Eligibility criteria:

        Inclusion Criteria:

          -  12 months of spontaneous amenorrhea, or 6 months of spontaneous amenorrhea with serum
             follicle stimulating hormone (FSH) concentrations > 40 mIU/mL, or 6 weeks postsurgical
             bilateral oophorectomy with or without hysterectomy, or hysterectomy with 2 (measured
             14 days apart) serum FSH concentrations > 40 mIU/mL.

          -  Is likely to experience at least 50 moderate to severe vasomotor symptoms ([MSVS] hot
             flushes and nocturnal sweating) per week while not receiving estrogen replacement
             therapy based on history of menopause, in the judgment of the investigator.

          -  Documented experiencing at least 50 MSVS per week during the 14 day baseline period
             before the Randomization Visit (Visit 3), based on the patient diary entries
             (calculated mean MSVS/week for the 14 day baseline period).

          -  If ≥ 40 years of age, has a documented negative mammogram and a normal clinical breast
             examination with no findings indicative of breast malignancy.

          -  Has a body mass index (BMI) < 35.0 kg/m2.

        Exclusion Criteria:

          -  Has a known history of allergic reaction or clinically significant intolerance to
             ingredients of the study drug.

          -  Received any of the following:oral or dermal estrogen/progestin or selective estrogen
             receptor modulator (SERM) containing drug product therapy within 8 weeks before
             Screening, injectable or implantable estrogen/progestin therapy within 3 months before
             Screening, hormone releasing intrauterine device

          -  Had unexplained or otherwise abnormal vaginal bleeding within 6 months before
             Screening.

          -  Has a history of, or currently has, any of the following conditions: thrombophlebitis,
             thromboembolic disease, estrogen dependent neoplasia, or carcinoma of the breast.

          -  Has a history of any untreated or uncontrolled endocrine disorders (e.g.,
             hyperparathyroidism, uncontrolled hyperthyroidism).

          -  Has any clinically significant unstable cardiac, respiratory, neurological,
             immunological, hematological, hepatic, renal, endocrine, or gastric disease or any
             other condition that, in the opinion of the investigator, could compromise the
             patient's welfare, ability to communicate with the study staff, or otherwise
             contraindicate study participation.

          -  Has clinically significant depression or severe psychiatric disturbances.

          -  Has active liver disease with aspartate aminotransferase (AST) > 3 times the upper
             limit of normal (ULN), alanine aminotransferase (ALT) > 3 times ULN, unexplained
             alkaline phosphatase > 3 times ULN, total bilirubin > 2 times ULN, renal insufficiency
             with creatinine > 1.7 mg/dL, or clinically significant abnormal hemoglobin, white
             blood cell count, or platelet count.

          -  Has an endometrial thickness ≥ 4 mm.

          -  Has a history indicative of endometrial hyperplasia or cancer.

          -  Shows presence of any manifest premalignant or malignant disease except treated skin
             cancers (except melanoma).

          -  Has known or suspected history of alcoholism or drug abuse or misuse within the past 5
             years.

          -  Has resting systolic blood pressure (BP) > 160 mmHg or < 90 mmHg, or diastolic BP > 90
             mmHg or < 60 mmHg at Screening.

          -  Has a history of smoking more than 5 cigarettes daily within the year before
             Screening.

          -  Has tested positive on the urine drug screen. Patients who test positive at Screening
             and can produce documentation from their physician for the medication that caused the
             positive test may be considered for study enrollment at the discretion of the
             investigator.

          -  Has significant difficulties swallowing capsules or is unable to tolerate oral
             medication.

          -  Has participated in another clinical trial or received any investigational drug or
             device or investigational therapy within 30 days before Screening.

          -  Has a disorder that affects gastrointestinal absorption.