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Completed

NCT Number: NCT01070979

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

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.

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Key information

Conditions

Hormone Replacement Therapy

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Warner Chilcott Investigational Site, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 40 years of age; bilateral oophorectomy ≥ 35 years of age.
  • 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.
  • 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

  • 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.
  • 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.
  • Urinary tract infection
  • Congestive heart failure
  • Uncontrolled hypertension; sitting systolic BP ≥ 160 mmHg or diastolic ≥ 95 mmHg
  • History of stroke or transient ischemic attacks
  • Treatment with anticoagulants (heparin or warfarin).
  • Uncontrolled thyroid disorders.
  • Insulin-dependent diabetes mellitus.
  • Increase frequency or severity of headaches including migraines during previous estrogen therapy.

Treatment and study plan

Estradiol acetate

Drug

Tablet containing 0.9 mg E3A, daily oral administration.

Estradiol

Drug

Tablet containing 1 mg estradiol, daily oral administration.

Other names: Estrace

Conjugated equine estrogens

Drug

Tablet containing 0.625 mg CEE, daily oral administration.

Other names: Premarin

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Feb 18, 2010
Registry last updated
Apr 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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