A Multicenter, Double-Blind, Controlled, Randomized Study to Compare the Efficacy in Relief of Hot Flushes in Women Receiving Oral Estradiol Acetate Tablets, Oral Estradiol Tablets or Oral Conjugated Equine Estrogens
Overview
- Phase
- Phase 3
- Intervention
- Estradiol acetate
- Conditions
- Hormone Replacement Therapy
- Sponsor
- Warner Chilcott
- Enrollment
- 249
- Locations
- 1
- Primary Endpoint
- Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 4, ITT (Intention to Treat) Population
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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.
Investigators
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 \< 20 pg /mL,
- •Hysterectomized women:
- •Bilateral oophorectomy - subjects may enter the study 6 weeks after surgery or
- •History of removal of ovaries may be confirmed by - serum FSH 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.
Arms & Interventions
Estradiol acetate (E3A)
Intervention: Estradiol acetate
Estradiol
Intervention: Estradiol
Conjugated equine estrogens (CEE):
Intervention: Conjugated equine estrogens
Outcomes
Primary Outcomes
Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 4, ITT (Intention to Treat) Population
Time Frame: Baseline to Week 4
Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep
Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 12, ITT Population
Time Frame: Baseline to Week 12
Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep
Secondary Outcomes
- Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 4, ITT Population(Baseline to Week 4)
- Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 12, ITT Population(Baseline to Week 12)
- Mean Change From Baseline in Total Urogenital Symptom Score, Week 4, ITT Population(Baseline to Week 4)
- Change From Baseline in Total Urogenital Symptom Score, Week 8, ITT Population(Baseline to Week 8)
- Change From Baseline in Total Urogenital Symptom Score, Week 12, ITT Population(Baseline to Week 12)