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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT01070979
First received: February 17, 2010
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Hormone Replacement Therapy
Drug: Estradiol acetate
Drug: Estradiol
Drug: Conjugated equine estrogens
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 4, ITT Population [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.


Enrollment: 249
Study Start Date: February 2003
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070979

  Show 32 Study Locations
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Herman Ellman, MD Warner Chilcott
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT01070979     History of Changes
Other Study ID Numbers: PR-03602.1
Study First Received: February 17, 2010
Results First Received: February 14, 2011
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Estrogens
Estrogens, Conjugated (USP)
Polyestradiol phosphate
Contraceptive Agents
Contraceptive Agents, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014