Phase 2
N=169
Efficacy and Safety of S-equol on Vasomotor Symptoms in Menopausal Patients
Menopause
Bottom Line
View on ClinicalTrials.gov: NCT00962585 ↗Enrolled (actual)
169
Serious AEs
1.2%
Results posted
Apr 2014
Primary outcome: Primary: Mean Change in Frequency of Moderate to Severe Vasomotor Symptoms (MSVS) Baseline at Week 4 (2-week Period) — 73.5; 69.5; 70.4; 67.9 Number of MSVS/2 weeks — p=0.5730
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); S-equol (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Ausio Pharmaceuticals, LLC
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Frequency of Moderate to Severe Vasomotor Symptoms (MSVS) Baseline at Week 4 (2-week Period) |
73.5; 69.5; 70.4; 67.9; 41.7; 46.1 | 0.5730 |
| SECONDARY Mean Change in Frequency of MSVS From Baseline at Week 4 (1-week Period) |
73.0; 71.4; 69.5; 67.9; 40.0; 45.5 | 0.7364 |
| SECONDARY Change From Baseline (Day 0) in the Frequency of MSVS at Week 1 and Week 2 |
53.6; 63.1; 54.4; 54.1; -19.9; -6.7 | 0.1217 |
| SECONDARY Change From Baseline (Day 0) in the Severity of VMS as Recorded in the Patient Diary at Week 1, Week 2, and Week 4 |
188.6; 177.1; 175.6; 172.8; 139.0; 160.4 | 0.1609 |
| SECONDARY Change From Baseline (Day 0) in Vaginal pH at Week 2 and Week 4 |
5.5; 5.5; 5.8; 5.7; 5.4; 5.4 | 0.2211 |
| SECONDARY Change From Baseline in Vaginal Maturation Index at Week 2 and Week 4 |
52.6; 55.7; 50.9; 43.5; 54.5; 54.3 | 0.6375 |
| SECONDARY Change From Baseline in Estradiol Concentration at Weeks 2 and 4 |
79.0; 65.7; 66.1; 59.6; 117.3; 72.2 | 0.0681 |
| SECONDARY Change From Baseline in Progesterone Concentration at Week 2 and Week 4 |
1.1; 1.1; 1.3; 1.1; 1.2; 1.3 | — |
| SECONDARY Mean Change in the Menopause Rating Scale Total Score From Baseline at Week 4 |
16.9; 17.3; 15.7; 14.5; 11.5; 10.8 | — |
| SECONDARY Mean Precentage Change in the Menopause Rating Scale Total Score From Baseline at Week 4 |
-36.7; -37.4; -30.6; -27.4 | 0.4352 |
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) 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 < 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.
Data sourced from ClinicalTrials.gov (NCT00962585). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.