Phase 3
Completed N=735
Low-dose Hormone Therapy for Relief of Vasomotor Symptoms
vasomotor symptoms · Hot Flashes
Source: ClinicalTrials.gov NCT00446199 ↗
Enrolled (actual)
735
Serious AEs
0.7%
Results posted
Apr 2012
Primary outcomePrimary: Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value) — -54.515; -54.125; -44.389; -30.020 Hot Flushes per week — p=<0.0001
Summary
The purpose of this study is to determine the lowest effective dose of the study drug for the relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value) |
-54.515; -54.125; -44.389; -30.020 | <0.0001 sig |
| PRIMARY Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value) |
-46.868; -37.596; -31.621; -15.109 | <0.0001 sig |
| PRIMARY Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value) |
-1.9294; -1.000; -0.2638; -0.0698 | <0.0001 sig |
| PRIMARY Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value) |
-0.2905; -0.1821; -0.0651; 0.0000 | <0.0001 sig |
| SECONDARY Change From Baseline to Week 12 in Vaginal pH |
-0.63; -0.63; -0.66; -0.06 | <0.0001 sig |
| SECONDARY Change From Baseline to Week 12 in Vaginal Maturation Value |
10.07; 11.71; 7.69; -2.41 | <0.0001 sig |
| SECONDARY Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Dryness' |
83; 70; 71; 70; 59; 52 | 0.0314 sig |
| SECONDARY Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal and/or Vulvar Irritation/Itching' |
152; 140; 146; 128; 20; 24 | 0.0027 sig |
| SECONDARY Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Dysuria' |
166; 169; 167; 153; 6; 2 | 0.4397 |
| SECONDARY Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Pain Associated With Sexual Activity' |
128; 132; 127; 118; 21; 22 | 0.9555 |
| SECONDARY Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Bleeding Associated With Sexual Activity' |
164; 162; 159; 151; 2; 2 | 0.8966 |
| SECONDARY Urogenital Symptoms: Number of Participants With Symptom 'Frequent Urination' |
45; 56; 62; 57 | 0.1067 |
| SECONDARY Urogenital Symptoms: Number of Participants With Symptom 'Involuntary Urination When Laughing or Coughing' |
70; 53; 53; 48 | 0.0144 sig |
| SECONDARY Urogenital Symptoms: Number of Participants With Symptom 'Urination at Night' |
99; 114; 114; 111 | 0.2179 |
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women >40 years of age experiencing a minimum of 7 to 8 moderate to severe hot flushes per day or 50 to 60 moderate to severe hot flushes per week
Exclusion Criteria
- The usual exclusion criteria for hormone therapy apply
- Intake of medications other than hormones affecting hot flushes
Data sourced from ClinicalTrials.gov (NCT00446199). 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. Informational only — not medical advice.