NCT01070979|CompletedPhase 3Results

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

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

Warner Chilcott ClinicalTrials.gov

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1 other identifier

PR-03602.1

Study Type

interventional

Target

249

Locations

1 country

Sites

Timeline

RegisteredFeb 2010

StartedFeb 2003

CompletionSep 2003

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

249

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Feb 2003

Shorter than P25 for phase_3

Geographic Reach

1 country

32 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7 months study duration

Study Start

First participant enrolled

February 1, 2003

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed

6.5 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2010

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

April 8, 2011

Completed

Last Updated

April 22, 2013

Status Verified

April 1, 2013

Enrollment Period

7 months

First QC Date

February 17, 2010

Results QC Date

February 14, 2011

Last Update Submit

April 15, 2013

Conditions

Hormone Replacement Therapy

Outcome Measures

Primary Outcomes (2)

Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 4, ITT (Intention to Treat) Population
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
Baseline to Week 4
Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 12, ITT Population
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
Baseline to Week 12

Secondary Outcomes (5)

Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 4, ITT Population
Baseline to Week 4
Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 12, ITT Population
Baseline to Week 12
Mean Change From Baseline in Total Urogenital Symptom Score, Week 4, ITT Population
Baseline to Week 4
Change From Baseline in Total Urogenital Symptom Score, Week 8, ITT Population
Baseline to Week 8
Change From Baseline in Total Urogenital Symptom Score, Week 12, ITT Population
Baseline to Week 12

Study Arms (3)

Estradiol acetate (E3A)

EXPERIMENTAL

Drug: Estradiol acetate

Estradiol

ACTIVE COMPARATOR

Drug: Estradiol

Conjugated equine estrogens (CEE):

ACTIVE COMPARATOR

Drug: Conjugated equine estrogens

Interventions

Estradiol acetateDRUG

Tablet containing 0.9 mg E3A, daily oral administration.

Estradiol acetate (E3A)

EstradiolDRUG

Tablet containing 1 mg estradiol, daily oral administration.

Also known as: Estrace

Estradiol

Conjugated equine estrogensDRUG

Tablet containing 0.625 mg CEE, daily oral administration.

Also known as: Premarin

Conjugated equine estrogens (CEE):

Eligibility Criteria

Age35 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.