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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01070979
Recruitment Status : Completed
First Posted : February 18, 2010
Results First Posted : April 8, 2011
Last Update Posted : April 22, 2013
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

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.

Condition or disease Intervention/treatment Phase
Hormone Replacement Therapy Drug: Estradiol acetate Drug: Estradiol Drug: Conjugated equine estrogens Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2003
Actual Primary Completion Date : September 2003
Actual Study Completion Date : September 2003


Arm Intervention/treatment
Experimental: Estradiol acetate (E3A) Drug: Estradiol acetate
Tablet containing 0.9 mg E3A, daily oral administration.

Active Comparator: Estradiol Drug: Estradiol
Tablet containing 1 mg estradiol, daily oral administration.
Other Name: Estrace

Active Comparator: Conjugated equine estrogens (CEE): Drug: Conjugated equine estrogens
Tablet containing 0.625 mg CEE, daily oral administration.
Other Name: Premarin




Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 4, ITT Population [ Time Frame: Baseline to Week 4 ]
    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.

  2. Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 12, ITT Population [ Time Frame: Baseline to Week 12 ]
    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.

  3. Mean Change From Baseline in Total Urogenital Symptom Score, Week 4, ITT Population [ Time Frame: Baseline to Week 4 ]
    Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.

  4. Change From Baseline in Total Urogenital Symptom Score, Week 8, ITT Population [ Time Frame: Baseline to Week 8 ]
    Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.

  5. Change From Baseline in Total Urogenital Symptom Score, Week 12, ITT Population [ Time Frame: Baseline to Week 12 ]
    Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01070979


Locations
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United States, Arizona
Warner Chilcott Investigational Site
Phoenix, Arizona, United States, 85031
United States, California
Warner Chilcott Investigational Site
Carmichael, California, United States, 95608
Warner Chilcott Investigational Site
San Diego, California, United States, 92108
Warner Chilcott Investigational Site
San Diego, California, United States, 92123
United States, Florida
Warner Chilcott Investigational Site
Aventura, Florida, United States, 33180
Warner Chilcott Investigational Site
Boynton Beach, Florida, United States, 33437
Warner Chilcott Investigational Site
Clearwater, Florida, United States, 33765
Warner Chilcott Investigational Site
Daytona Beach, Florida, United States, 32114
Warner Chilcott Investigational Site
Gainesville, Florida, United States, 32605
Warner Chilcott Investigational Site
Longwood, Florida, United States, 32779
Warner Chilcott Investigational Site
Melbourne, Florida, United States, 32935
Warner Chilcott Investigational Site
Miami, Florida, United States, 33143
Warner Chilcott Investigational Site
Palm Springs, Florida, United States, 33461
Warner Chilcott Investigational Site
Pinellas Park, Florida, United States, 33781
Warner Chilcott Investigational Site
Sarasota, Florida, United States, 34232
Warner Chilcott Investigational Site
Venice, Florida, United States, 34285
United States, Georgia
Warner Chilcott Investigational Site
Roswell, Georgia, United States, 30075
United States, Illinois
Warner Chilcott Investigational Site
Chicago, Illinois, United States, 60612
Warner Chilcott Investigational Site
Peoria, Illinois, United States, 61615
United States, Maryland
Warner Chilcott Investigational Site
Laurel, Maryland, United States, 20707
United States, Nebraska
Warner Chilcott Investigational Site
Lincoln, Nebraska, United States, 68510
United States, North Carolina
Warner Chilcott Investigational Site
Raleigh, North Carolina, United States, 27612
Warner Chilcott Investigational Site
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Warner Chilcott Investigational Site
Cleveland, Ohio, United States, 44122
Warner Chilcott Investigational Site
Columbus, Ohio, United States, 43212
Warner Chilcott Investigational Site
Mogadore, Ohio, United States, 44260
United States, Oregon
Warner Chilcott Investigational Site
Portland, Oregon, United States, 97201
United States, Pennsylvania
Warner Chilcott Investigational Site
Pittsburgh, Pennsylvania, United States, 15206
United States, Tennessee
Warner Chilcott Investigational Site
Nashville, Tennessee, United States, 37203
United States, Utah
Warner Chilcott Investigational Site
Salt Lake City, Utah, United States, 84124
United States, Washington
Warner Chilcott Investigational Site
Spokane, Washington, United States, 99201
Warner Chilcott Investigational Site
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Warner Chilcott
Investigators
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Study Director: Herman Ellman, MD Warner Chilcott
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Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT01070979    
Other Study ID Numbers: PR-03602.1
First Posted: February 18, 2010    Key Record Dates
Results First Posted: April 8, 2011
Last Update Posted: April 22, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Hot Flashes
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Estrogens
Estrogens, Conjugated (USP)
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female