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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01070979
Other study ID # PR-03602.1
Secondary ID
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


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
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