Hormone Replacement Therapy for Use in Postmenopausal Women for Relief of Hot Flushes and Urogenital Symptoms.

Hormone Replacement Therapy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070979
• Other study ID #: PR-03602.1
• Status: Completed
• Phase: Phase 3
• First received: February 17, 2010
• Last updated: April 15, 2013
• Start date: February 2003
• Est. completion date: September 2003

Study information

• Verified date: April 2013
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hormone Replacement Therapy

Intervention

Drug:
• Estradiol acetate
Tablet containing 0.9 mg E3A, daily oral administration.
• Estradiol
Tablet containing 1 mg estradiol, daily oral administration.
• Conjugated equine estrogens
Tablet containing 0.625 mg CEE, daily oral administration.

Locations

Country	Name	City	State
United States	Warner Chilcott Investigational Site	Aventura	Florida
United States	Warner Chilcott Investigational Site	Boynton Beach	Florida
United States	Warner Chilcott Investigational Site	Carmichael	California
United States	Warner Chilcott Investigational Site	Chicago	Illinois
United States	Warner Chilcott Investigational Site	Clearwater	Florida
United States	Warner Chilcott Investigational Site	Cleveland	Ohio
United States	Warner Chilcott Investigational Site	Columbus	Ohio
United States	Warner Chilcott Investigational Site	Daytona Beach	Florida
United States	Warner Chilcott Investigational Site	Gainesville	Florida
United States	Warner Chilcott Investigational Site	Laurel	Maryland
United States	Warner Chilcott Investigational Site	Lincoln	Nebraska
United States	Warner Chilcott Investigational Site	Longwood	Florida
United States	Warner Chilcott Investigational Site	Melbourne	Florida
United States	Warner Chilcott Investigational Site	Miami	Florida
United States	Warner Chilcott Investigational Site	Mogadore	Ohio
United States	Warner Chilcott Investigational Site	Nashville	Tennessee
United States	Warner Chilcott Investigational Site	Palm Springs	Florida
United States	Warner Chilcott Investigational Site	Peoria	Illinois
United States	Warner Chilcott Investigational Site	Phoenix	Arizona
United States	Warner Chilcott Investigational Site	Pinellas Park	Florida
United States	Warner Chilcott Investigational Site	Pittsburgh	Pennsylvania
United States	Warner Chilcott Investigational Site	Portland	Oregon
United States	Warner Chilcott Investigational Site	Raleigh	North Carolina
United States	Warner Chilcott Investigational Site	Roswell	Georgia
United States	Warner Chilcott Investigational Site	Salt Lake City	Utah
United States	Warner Chilcott Investigational Site	San Diego	California
United States	Warner Chilcott Investigational Site	San Diego	California
United States	Warner Chilcott Investigational Site	Sarasota	Florida
United States	Warner Chilcott Investigational Site	Spokane	Washington
United States	Warner Chilcott Investigational Site	Tacoma	Washington
United States	Warner Chilcott Investigational Site	Venice	Florida
United States	Warner Chilcott Investigational Site	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 4, ITT (Intention to Treat) Population	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	Baseline to Week 4	No
Primary	Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 12, ITT Population	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	Baseline to Week 12	No
Secondary	Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 4, ITT Population	Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes.	Baseline to Week 4	No
Secondary	Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 12, ITT Population	Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes.	Baseline to Week 12	No
Secondary	Mean Change From Baseline in Total Urogenital Symptom Score, Week 4, ITT Population	Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.	Baseline to Week 4	No
Secondary	Change From Baseline in Total Urogenital Symptom Score, Week 8, ITT Population	Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.	Baseline to Week 8	No
Secondary	Change From Baseline in Total Urogenital Symptom Score, Week 12, ITT Population	Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.	Baseline to Week 12	No