Efficacy and Safety of S-equol on Vasomotor Symptoms in Menopausal Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Menopause

In brief

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

Key facts

Study ID

NCT00962585

Run by

Ausio Pharmaceuticals, LLC

People needed

169

Starts

2010-06-01

Expected to finish

2011-11-01

Last updated by the study team

2014-04-08

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Bluegrass Clinical Research — Louisville, Kentucky, United States
• Greater Cincinnati OB/GYN, Inc. — Cincinnati, Ohio, United States
• Rapid Medical Research — Cleveland, Ohio, United States
• Radiant Research, Inc — Greenville, South Carolina, United States
• Advanced Clinical Research — West Jordon, Utah, United States
• Sydney Centre for Reproductive Health Research — Ashfield, New South Wales, Australia
• Royal Hospital for Women — Randwick, New South Wales, Australia
• Women's Health Center, Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Emeritus Research — Malvern East, Victoria, Australia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.