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

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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

Tracking Information
First Submitted Date  ICMJE February 17, 2010
First Posted Date  ICMJE February 18, 2010
Results First Submitted Date  ICMJE February 14, 2011
Results First Posted Date  ICMJE April 8, 2011
Last Update Posted Date April 22, 2013
Study Start Date  ICMJE February 2003
Actual Primary Completion Date September 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2011)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: February 17, 2010)
To determine the effectiveness of continuous administration of estradiol acetate compared with estradiol and conjugated equine estrogens in decreasing the frequency and severity of hot flushes in postmenopausal women. [ Time Frame: Differences in change in hot flush frequency and severity at Weeks 4, 8 and 12 between estradiol acetate group compared to estradiol and conjugated equine estrogens groups. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2011)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2010)
To evaluate the effectiveness of the treatment regimen in relieving urogenital symptoms:vaginal dryness, dyspareunia, urinary urgency, dysuria, urinary incontinence, nocturia, vaginal irritation/itching and bleeding after intercourse. [ Time Frame: Differences in prevalence and severity of each symptom at Weeks 4, 8 and 12 between estradiol acetate group compared to estradiol and conjugated equine estrogens groups. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hormone Replacement Therapy for Use in Postmenopausal Women for Relief of Hot Flushes and Urogenital Symptoms.
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hormone Replacement Therapy
Intervention  ICMJE
  • Drug: Estradiol acetate
    Tablet containing 0.9 mg E3A, daily oral administration.
  • Drug: Estradiol
    Tablet containing 1 mg estradiol, daily oral administration.
    Other Name: Estrace
  • Drug: Conjugated equine estrogens
    Tablet containing 0.625 mg CEE, daily oral administration.
    Other Name: Premarin
Study Arms  ICMJE
  • Experimental: Estradiol acetate (E3A)
    Intervention: Drug: Estradiol acetate
  • Active Comparator: Estradiol
    Intervention: Drug: Estradiol
  • Active Comparator: Conjugated equine estrogens (CEE):
    Intervention: Drug: Conjugated equine estrogens
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2011)
249
Original Actual Enrollment  ICMJE
 (submitted: February 17, 2010)
210
Actual Study Completion Date  ICMJE September 2003
Actual Primary Completion Date September 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01070979
Other Study ID Numbers  ICMJE PR-03602.1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Warner Chilcott
Study Sponsor  ICMJE Warner Chilcott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Herman Ellman, MD Warner Chilcott
PRS Account Warner Chilcott
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP