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

NCT ID: NCT01070979

Last Updated: 2013-04-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

249 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2003-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Hormone Replacement Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Estradiol acetate (E3A)

Group Type EXPERIMENTAL

Estradiol acetate

Intervention Type DRUG

Tablet containing 0.9 mg E3A, daily oral administration.

Estradiol

Group Type ACTIVE_COMPARATOR

Estradiol

Intervention Type DRUG

Tablet containing 1 mg estradiol, daily oral administration.

Conjugated equine estrogens (CEE):

Group Type ACTIVE_COMPARATOR

Conjugated equine estrogens

Intervention Type DRUG

Tablet containing 0.625 mg CEE, daily oral administration.

Interventions

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Estradiol acetate

Tablet containing 0.9 mg E3A, daily oral administration.

Intervention Type DRUG

Estradiol

Tablet containing 1 mg estradiol, daily oral administration.

Intervention Type DRUG

Conjugated equine estrogens

Tablet containing 0.625 mg CEE, daily oral administration.

Intervention Type DRUG

Other Intervention Names

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Estrace Premarin

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Warner Chilcott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Herman Ellman, MD

Role: STUDY_DIRECTOR

Warner Chilcott

Locations

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Warner Chilcott Investigational Site

Phoenix, Arizona, United States

Site Status

Warner Chilcott Investigational Site

Carmichael, California, United States

Site Status

Warner Chilcott Investigational Site

San Diego, California, United States

Site Status

Warner Chilcott Investigational Site

San Diego, California, United States

Site Status

Warner Chilcott Investigational Site

Aventura, Florida, United States

Site Status

Warner Chilcott Investigational Site

Boynton Beach, Florida, United States

Site Status

Warner Chilcott Investigational Site

Clearwater, Florida, United States

Site Status

Warner Chilcott Investigational Site

Daytona Beach, Florida, United States

Site Status

Warner Chilcott Investigational Site

Gainesville, Florida, United States

Site Status

Warner Chilcott Investigational Site

Longwood, Florida, United States

Site Status

Warner Chilcott Investigational Site

Melbourne, Florida, United States

Site Status

Warner Chilcott Investigational Site

Miami, Florida, United States

Site Status

Warner Chilcott Investigational Site

Palm Springs, Florida, United States

Site Status

Warner Chilcott Investigational Site

Pinellas Park, Florida, United States

Site Status

Warner Chilcott Investigational Site

Sarasota, Florida, United States

Site Status

Warner Chilcott Investigational Site

Venice, Florida, United States

Site Status

Warner Chilcott Investigational Site

Roswell, Georgia, United States

Site Status

Warner Chilcott Investigational Site

Chicago, Illinois, United States

Site Status

Warner Chilcott Investigational Site

Peoria, Illinois, United States

Site Status

Warner Chilcott Investigational Site

Laurel, Maryland, United States

Site Status

Warner Chilcott Investigational Site

Lincoln, Nebraska, United States

Site Status

Warner Chilcott Investigational Site

Raleigh, North Carolina, United States

Site Status

Warner Chilcott Investigational Site

Winston-Salem, North Carolina, United States

Site Status

Warner Chilcott Investigational Site

Cleveland, Ohio, United States

Site Status

Warner Chilcott Investigational Site

Columbus, Ohio, United States

Site Status

Warner Chilcott Investigational Site

Mogadore, Ohio, United States

Site Status

Warner Chilcott Investigational Site

Portland, Oregon, United States

Site Status

Warner Chilcott Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

Warner Chilcott Investigational Site

Nashville, Tennessee, United States

Site Status

Warner Chilcott Investigational Site

Salt Lake City, Utah, United States

Site Status

Warner Chilcott Investigational Site

Spokane, Washington, United States

Site Status

Warner Chilcott Investigational Site

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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PR-03602.1

Identifier Type: -

Identifier Source: org_study_id

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