Phase 3
Completed N=249
Hormone Replacement Therapy for Use in Postmenopausal Women for Relief of Hot Flushes and Urogenital Symptoms.
Hormone Replacement Therapy
Source: ClinicalTrials.gov NCT01070979 ↗
Enrolled (actual)
249
Serious AEs
0.4%
Results posted
Apr 2011
Primary outcomePrimary: Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 4, ITT (Intention to Treat) Population — -54.1; -62.0; -54.5 Change in Hot Flush Count
Summary
Multicenter, double-blind, controlled, parallel group, randomized study to compare the clinical benefit of Estradiol acetate tablets, estradiol tablets and conjugated equine estrogen tablets, each administered orally, once daily, to postmenopausal women.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 4, ITT (Intention to Treat) Population |
-54.1; -62.0; -54.5 | — |
| PRIMARY Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 12, ITT Population |
-63.6; -72.2; -67.2 | — |
| SECONDARY Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 4, ITT Population |
-0.53; -0.51; -0.59 | — |
| SECONDARY Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 12, ITT Population |
-1.05; -1.34; -1.17 | — |
| SECONDARY Mean Change From Baseline in Total Urogenital Symptom Score, Week 4, ITT Population |
-1.89; -2.26; -1.96 | — |
| SECONDARY Change From Baseline in Total Urogenital Symptom Score, Week 8, ITT Population |
-1.96; -2.58; -2.42 | — |
| SECONDARY Change From Baseline in Total Urogenital Symptom Score, Week 12, ITT Population |
-2.49; -2.59; -2.52 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 40 years of age; bilateral oophorectomy ≥ 35 years of age.
- Non-hysterectomized women:
- Amenorrhea for ≥ 12 months or
- Amenorrhea for ≤ 12 months, but longer than 6 months, and serum FSH (follicle stimulating hormone) levels > 40 units/L and serum estradiol levels 40 units/L and serum estradiol levels < 20 pg/mL or via surgical report / ultrasound.
- Seven or more moderate or severe hot flushes daily for 1 week or 60 or more moderate or severe flushes in 1 week during the 2 week screening period prior to study entry.
Exclusion Criteria
- Hormone therapy administered via the following routes and during the specified timeframes: oral within 8 weeks, vaginal (rings, creams, gels) within 1 week, transdermal within 4 weeks, intramuscular within 6 weeks, progestational implants, estrogen or estrogen/progestational injectable drug therapy within 3 months, estrogen pellet or progestational injectable within 6 months.
- Abnormal Pap smear suggestive of low grade squamous intraepithelial lesion (LGSIL) or worse. Enrollment of subjects with an ASCUS (atypical squamous cells of undetermined significance) interpretation must be discussed with the sponsor prior to randomization.
- Urinary tract infection
- Congestive heart failure
- Uncontrolled hypertension; sitting systolic BP ≥ 160 mmHg or diastolic ≥ 95 mmHg
- History of stroke or transient ischemic attacks
- Treatment with anticoagulants (heparin or warfarin).
- Uncontrolled thyroid disorders.
- Insulin-dependent diabetes mellitus.
- Increase frequency or severity of headaches including migraines during previous estrogen therapy.
Data sourced from ClinicalTrials.gov (NCT01070979). 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.