Clinical trial NCT01070979: Hormone Replacement Therapy for Use in Postmenopausal Women for Relief of Hot Flushes and Urogenital Symptoms.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hormone Replacement Therapy
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2010-02-18
Enrollment: 249
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 40 years of age; bilateral oophorectomy ≥ 35 years of age.
2. 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.
3. 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:

1. 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.
2. 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.
3. Urinary tract infection
4. Congestive heart failure
5. Uncontrolled hypertension; sitting systolic BP ≥ 160 mmHg or diastolic ≥ 95 mmHg
6. History of stroke or transient ischemic attacks
7. Treatment with anticoagulants (heparin or warfarin).
8. Uncontrolled thyroid disorders.
9. Insulin-dependent diabetes mellitus.
10. Increase frequency or severity of headaches including migraines during previous estrogen therapy.

Primary outcomes:
measure: Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 4, ITT (Intention to Treat) Population
timeFrame: Baseline to Week 4
measure: Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 12, ITT Population
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 4, ITT Population
timeFrame: Baseline to Week 4
measure: Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 12, ITT Population
timeFrame: Baseline to Week 12
measure: Mean Change From Baseline in Total Urogenital Symptom Score, Week 4, ITT Population
timeFrame: Baseline to Week 4
measure: Change From Baseline in Total Urogenital Symptom Score, Week 8, ITT Population
timeFrame: Baseline to Week 8
measure: Change From Baseline in Total Urogenital Symptom Score, Week 12, ITT Population
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Carmichael
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: San Diego
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: San Diego
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Aventura
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Boynton Beach
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Daytona Beach
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Longwood
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Miami
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Palm Springs
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Pinellas Park
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Venice
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Roswell
country: United States
facility: Warner Chilcott Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Warner Chilcott Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Warner Chilcott Investigational Site
state: Illinois
city: Laurel
country: United States
facility: Warner Chilcott Investigational Site
state: Maryland
city: Lincoln
country: United States
facility: Warner Chilcott Investigational Site
state: Nebraska
city: Raleigh
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Winston Salem
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Warner Chilcott Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Warner Chilcott Investigational Site
state: Ohio
city: Mogadore
country: United States
facility: Warner Chilcott Investigational Site
state: Ohio
city: Portland
country: United States
facility: Warner Chilcott Investigational Site
state: Oregon
city: Pittsburgh
country: United States
facility: Warner Chilcott Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: Warner Chilcott Investigational Site
state: Tennessee
city: Salt Lake City
country: United States
facility: Warner Chilcott Investigational Site
state: Utah
city: Spokane
country: United States
facility: Warner Chilcott Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Warner Chilcott Investigational Site
state: Washington
Study officials:
affiliation: Warner Chilcott
name: Herman Ellman, MD
role: STUDY_DIRECTOR
References: