Hormone Replacement TherapyPhase 3NCT01070979
Hormone Replacement Therapy for Use in Postmenopausal Women for Relief of Hot Flushes and Urogenital Symptoms.
A Phase 3 study testing Estradiol acetate, Estradiol and Conjugated equine estrogens in people with Hormone Replacement Therapy, run by Warner Chilcott at 32 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Hormone Replacement Therapy
- What is being tested?
- Estradiol acetate, Estradiol and Conjugated equine estrogens
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 32 sitesUnited States
- Study dates
- Feb 2003to Sep 2003
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Warner Chilcott Investigational Site
Aventura, Florida, 33180
Warner Chilcott Investigational Site
Boynton Beach, Florida, 33437
Warner Chilcott Investigational Site
Carmichael, California, 95608
Warner Chilcott Investigational Site
Chicago, Illinois, 60612
Warner Chilcott Investigational Site
Clearwater, Florida, 33765
Warner Chilcott Investigational Site
Cleveland, Ohio, 44122
Warner Chilcott Investigational Site
Columbus, Ohio, 43212
Warner Chilcott Investigational Site
Daytona Beach, Florida, 32114
Warner Chilcott Investigational Site
Gainesville, Florida, 32605
Warner Chilcott Investigational Site
Laurel, Maryland, 20707
Warner Chilcott Investigational Site
Lincoln, Nebraska, 68510
Warner Chilcott Investigational Site
Longwood, Florida, 32779
Warner Chilcott Investigational Site
Melbourne, Florida, 32935
Warner Chilcott Investigational Site
Miami, Florida, 33143
Warner Chilcott Investigational Site
Mogadore, Ohio, 44260
Warner Chilcott Investigational Site
Nashville, Tennessee, 37203
Warner Chilcott Investigational Site
Palm Springs, Florida, 33461
Warner Chilcott Investigational Site
Peoria, Illinois, 61615
Warner Chilcott Investigational Site
Phoenix, Arizona, 85031
Warner Chilcott Investigational Site
Pinellas Park, Florida, 33781
Warner Chilcott Investigational Site
Pittsburgh, Pennsylvania, 15206
Warner Chilcott Investigational Site
Portland, Oregon, 97201
Warner Chilcott Investigational Site
Raleigh, North Carolina, 27612
Warner Chilcott Investigational Site
Roswell, Georgia, 30075
Warner Chilcott Investigational Site
Salt Lake City, Utah, 84124
Warner Chilcott Investigational Site
San Diego, California, 92108
Warner Chilcott Investigational Site
San Diego, California, 92123
Warner Chilcott Investigational Site
Sarasota, Florida, 34232
Warner Chilcott Investigational Site
Spokane, Washington, 99201
Warner Chilcott Investigational Site
Tacoma, Washington, 98405
Warner Chilcott Investigational Site
Venice, Florida, 34285
Warner Chilcott Investigational Site
Winston-Salem, North Carolina, 27103
About this study
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
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.
- Conditions
- Hormone Replacement Therapy
- Being tested
- Estradiol acetate, Estradiol, Conjugated equine estrogens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol acetateDrug
Tablet containing 0.9 mg E3A, daily oral administration.
EstradiolDrug
Also called Estrace
Tablet containing 1 mg estradiol, daily oral administration.
Conjugated equine estrogensDrug
Also called Premarin
Tablet containing 0.625 mg CEE, daily oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Estradiol acetate (E3A) | Experimental | Not described Receives: Drug: Estradiol acetate |
| Estradiol | Active comparator | Not described Receives: Drug: Estradiol |
| Conjugated equine estrogens (CEE): | Active comparator | Not described Receives: Drug: Conjugated equine estrogens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline to Week 12
Secondary outcomes (5)
Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 4, ITT Population
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.
Measured: Baseline to Week 4
Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 12, ITT Population
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.
Measured: Baseline to Week 12
Mean Change From Baseline in Total Urogenital Symptom Score, Week 4, ITT Population
Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.
Measured: Baseline to Week 4
Change From Baseline in Total Urogenital Symptom Score, Week 8, ITT Population
Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.
Measured: Baseline to Week 8
Change From Baseline in Total Urogenital Symptom Score, Week 12, ITT Population
Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startFeb 2003
- Primary completionSep 2003
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hormone Replacement TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herman Ellman, MD, Study director, Warner Chilcott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070979
- Sponsor's protocol ID
- PR-03602.1
- Status last verified
- Apr 2013
- First submitted
- 17 Feb 2010
- Last updated
- 22 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01070979
- Acronym / sponsor ID
- PR-03602.1
- Conditions
- Hormone Replacement Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 18 Feb 2010 (estimated)
- Results
- Posted 8 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Estradiol acetate (E3A) | Experimental | Drug: Estradiol acetate |
| Estradiol | Active comparator | Drug: Estradiol |
| Conjugated equine estrogens (CEE): | Active comparator | Drug: Conjugated equine estrogens |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 40 years of age; bilateral oophorectomy ≥ 35 years of age.
- Non-hysterectomized women:
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estradiol acetateTablet containing 0.9 mg E3A, daily oral administration. | Drug | Estradiol acetate (E3A) |
| EstradiolAlso: EstraceTablet containing 1 mg estradiol, daily oral administration. | Drug | Estradiol |
| Conjugated equine estrogensAlso: PremarinTablet containing 0.625 mg CEE, daily oral administration. | Drug | Conjugated equine estrogens (CEE): |
Primary outcome
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
5 secondary outcomes
Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 4, ITT Population
Time frame: Baseline to Week 4
Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 12, ITT Population
Time frame: Baseline to Week 12
Mean Change From Baseline in Total Urogenital Symptom Score, Week 4, ITT Population
Time frame: Baseline to Week 4
Change From Baseline in Total Urogenital Symptom Score, Week 8, ITT Population
Time frame: Baseline to Week 8
Change From Baseline in Total Urogenital Symptom Score, Week 12, ITT Population
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herman Ellman, MD study director
Warner Chilcott
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Estradiol acetate, Estradiol and Conjugated equine estrogens in people with Hormone Replacement Therapy, run by Warner Chilcott at 32 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2013.