Coronary Heart DiseasePhase 3NCT00319566
Heart and Estrogen-Progestin Replacement Study (HERS)
A Phase 3 study testing Premarin .625 mg daily plus medroxyprogesterone 2.5 mg daily in people with Coronary Heart Disease, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of the study is to determine whether hormone replacement therapy in post menopausal women with coronary artery disease prevents future heart attacks or death from coronary heart disease. Read more about this study
- Who is it for?
- Ages 55 to 75 years, women only
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Premarin .625 mg daily plus medroxyprogesterone 2.5 mg daily
- How many people
- 2,430 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1992to Jul 2001
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 55 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- <75 y.o.
- uterus present
- postmenopausal
- evidence of CHD
- signed consent
Who cannot join
- MI, CABG, mechanical revascularization within 6 months
- serum triglyceride >300mg/dl
- used hormone therapy or estrogen vaginal cream in past 3 months
- history of DVT or pulmonary embolism
- history of breast cancer or mammogram suggestive of cancer
- history of endometrial cancer
Show all 15Show fewer
- abnormal uterine bleeding
- pap smear abnormal
- SGOT more than 1.2 times normal
- Disease judged to be fatal within 4 yrs
- alcoholism, drug abuse
- NYHA Class IV congestive heart failure
- uncontrolled hypertension
- uncontrolled diabetes
- participation in any other investigational study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
The purpose of the study is to determine whether hormone replacement therapy in post menopausal women with coronary artery disease prevents future heart attacks or death from coronary heart disease.
Read the detailed description
A randomized, blinded trial in post menopausal women with cornaornary artery disease to test the hypothesis, among 2340 women who have a uterus, that those randomized to receive estrogen-progestin replacement therapy (Premanrin .625 mg daily plus medroxygrprogesterone acetate 2.5 mg daily) have the same frequency on new CHD events (myocardial infarction and CHD death) as those randomized to placebo.
- Conditions
- Coronary Heart Disease
- Being tested
- Premarin .625 mg daily plus medroxyprogesterone 2.5 mg daily
- Keywords
- Coronary Heart Disease, Hormone replacement therapy, Estrogen, Postmenopausal women
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premarin .625 mg daily plus medroxyprogesterone 2.5 mg dailyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Infarction
CHD Death
Secondary outcomes (14)
CABG, revascularization, angina
serum lipids
quality of life
compliance
incidence of uterine bleeding and endometrial hyperplasia
incidencet and severity of vasomotor and genitourinary symptoms
adverse effects
thromboembolic events
symptomatic gallbladder disease
fractures
cancer
stroke
peripheral arterial disease
total mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startJul 1992
- Study completionJul 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 2,430 participants
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Investigators
- Stephen Hulley, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319566
- Sponsor's protocol ID
- 713B-401-US
- Status last verified
- Jan 2002
- First submitted
- 27 Apr 2006
- Last updated
- 27 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart and Estrogen-Progestin Replacement Study (HERS)
- ClinicalTrials.gov ID
- NCT00319566
- Acronym / sponsor ID
- 713B-401-US
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary Heart Disease, Hormone replacement therapy, Estrogen, Postmenopausal women
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,430 participants
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Jul 1992
- Study completion
- Jul 2001
- First posted
- 27 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether hormone replacement therapy in post menopausal women with coronary artery disease prevents future heart attacks or death from coronary heart disease.
Detailed description
A randomized, blinded trial in post menopausal women with cornaornary artery disease to test the hypothesis, among 2340 women who have a uterus, that those randomized to receive estrogen-progestin replacement therapy (Premanrin .625 mg daily plus medroxygrprogesterone acetate 2.5 mg daily) have the same frequency on new CHD events (myocardial infarction and CHD death) as those randomized to placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- <75 y.o.
- uterus present
- postmenopausal
- evidence of CHD
- signed consent
Key exclusion criteria (15 listed)
- MI, CABG, mechanical revascularization within 6 months
- serum triglyceride >300mg/dl
- used hormone therapy or estrogen vaginal cream in past 3 months
- history of DVT or pulmonary embolism
- history of breast cancer or mammogram suggestive of cancer
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 |
|---|---|---|
| Premarin .625 mg daily plus medroxyprogesterone 2.5 mg daily | Drug | – |
Primary outcome
Myocardial Infarction
CHD Death
14 secondary outcomes
CABG, revascularization, angina
serum lipids
quality of life
compliance
incidence of uterine bleeding and endometrial hyperplasia
incidencet and severity of vasomotor and genitourinary symptoms
adverse effects
thromboembolic events
symptomatic gallbladder disease
fractures
cancer
stroke
peripheral arterial disease
total mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2006.
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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.
Stephen Hulley principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Premarin .625 mg daily plus medroxyprogesterone 2.5 mg daily in people with Coronary Heart Disease, run by University of California, San Francisco at 1 site 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 5 inclusion and 15 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 27 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Myocardial Infarction. 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 27 Apr 2006.