DysmenorrheaPhase 2NCT00318500
Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women
A Phase 2 study testing ERB-041 in people with Dysmenorrhea and Dyspareunia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 70 sites in 7 countries.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of two doses of ERB-041 (75 mg and 150 mg) relative to placebo on the relief of endometriosis-related symptoms (dysmenorrhea, pelvic pain, and deep dyspareunia) in reproductive aged women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Dysmenorrhea, Dyspareunia, Endometriosis
- What is being tested?
- ERB-041
- How many people
- 150 participants
- Where
- 70 sitesin 7 countries
- Study dates
- May 2006to Dec 2006
- Phase
- Phase 2
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Surgical diagnosis of endometriosis within the last 10 years
- Sexually active, nonpregnant, nonlactating women (18-45 years) with regular menstrual cycles who are willing to use non-hormonal contraception
Who cannot join
- Conditions requiring the use of chronic pain therapy
- Prophylactic use of analgesics to avoid endometriosis-related pain
Trial locations and contacts
70 sites in 7 countries.
70 sites in 7 countries
United States49 sites
Study site
Abington, Pennsylvania, 19001
Study site
Bristol, Tennessee, 37620
Study site
Chandler, Arizona, 85225
Study site
Chattanooga, Tennessee, 37403
Study site
Clearwater, Florida, 33759
Study site
Cleveland, Ohio, 44122
Study site
Columbia, South Carolina, 29201
Study site
Corpus Christi, Texas, 78414
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Denver, Colorado, 80202
Study site
Denver, Colorado, 80206
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Durham, North Carolina, 27710
Study site
Evansville, Indiana, 47714
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Greenville, South Carolina, 29607
Study site
Idaho Falls, Idaho, 83404
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Lansdale, Pennsylvania, 19446
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Lawrenceville, New Jersey, 08648
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Madison, Wisconsin, 53792
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Marietta, Georgia, 30066
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Memphis, Tennessee, 38119
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Miamisburg, Ohio, 45342
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Montgomery, Alabama, 36116
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New Bern, North Carolina, 28562
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New Britain, Connecticut, 06050
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New Port Richey, Florida, 34652
Study site
Norfolk, Virginia, 23507
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Oak Brook, Illinois, 60523
Study site
Oklahoma City, Oklahoma, 73112
Study site
Philadelphia, Pennsylvania, 19107
Study site
Philadelphia, Pennsylvania, 19114
Study site
Phoenix, Arizona, 85032
Study site
Phoenix, Arizona, 85035
Study site
Pittsburgh, Pennsylvania, 15243
Study site
Plantation, Florida, 33324
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Portland, Oregon, 97210
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Raleigh, North Carolina, 27612
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Reno, Nevada, 89502
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Renton, Washington, 98055
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Richmond, Virginia, 23233
Study site
Richmond, Virginia, 23294
Study site
San Antonio, Texas, 78229
Study site
San Francisco, California, 94115
Study site
Tucson, Arizona, 85712
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Venice, Florida, 34285
Study site
Virginia Beach, Virginia, 23456
Study site
Vista, California, 92083
Study site
West Palm Beach, Florida, 33401
Study site
West Palm Beach, Florida, 33409
Study site
West Valley City, Utah, 84120
Study site
Winston-Salem, North Carolina, 27103
Canada7 sites
Study site
Calgary, Alberta, T2N 4L7
Study site
Halifax, Nova Scotia, B3H 2N1
Study site
London, Ontario, N6A 4V2
Study site
Saskatoon, Saskatchewan, S7K 1N4
Study site
Toronto, Ontario, M5B 1W8
Study site
Vancouver, British Columbia, V6Z 1Y6
Study site
Winnipeg, Manitoba, R3A 1R9
Australia4 sites
Study site
Nedlands, Western Australia, 6009
Study site
Randwick, New South Wales, 2031
Study site
Richmond, Victoria, 3121
Study site
Sydney, New South Wales, 200
South Africa4 sites
Study site
Cape Town, Capetown, 7925
Study site
Durban, KwaZulu-Natal, 4320
Study site
Port Elizabeth, Eastern Cape, 6001
Study site
Roodepoort, Jgb Gauteng, 1724
United Kingdom4 sites
Study site
Glasgow, Scotland, G51 4TF
Study site
Nottingham, Nottinghamshire, NG7 2UH
Study site
Sheffield, South Yorshire, S10 2SF
Study site
Swindon, Wiltshire, SN3 6BD
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 75 mg and 150 mg Doses of ERB-041 on the Reduction of Symptoms Associated With Endometriosis During Treatment and Post Treatment in Reproductive-Aged Women
The purpose of the study is to evaluate the efficacy and safety of two doses of ERB-041 (75 mg and 150 mg) relative to placebo on the relief of endometriosis-related symptoms (dysmenorrhea, pelvic pain, and deep dyspareunia) in reproductive aged women.
- Conditions
- Dysmenorrhea, Dyspareunia, Endometriosis, Pelvic Pain
- Being tested
- ERB-041
- Keywords
- Endometriosis, Dysmenorrhea, Pelvic pain, Dyspareunia
- Medical subject headings
- Dysmenorrhea, Dyspareunia, Endometriosis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERB-041Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
severity scores for dysmenorrhea, pelvic pain and deep dyspareunia from baseline through 12 weeks of treatment using the B & B scale administered by the investigator
Secondary outcomes (3)
change in severity scores for pelvic tenderness and pelvic induration during 12 weeks of treatment
change in rescue medication use
change in health related quality of life questionnaires
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2006 (estimated)
- Study startMay 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of PfizerTrial Manager, Principal investigator, For United Kingdom, ukmedinfo@wyeth.comTrial Manager, Principal investigator, For Australia and Hong Kong, medinfo@wyeth.comTrial Manager, Principal investigator, For South Africa, ZAFinfo@wyeth.comTrial Manager, Principal investigator, For Belgium, trials-BEL@wyeth.comTrial Manager, Principal investigator, For Canada, clintrialparticipation@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318500
- Sponsor's protocol ID
- 3142A2-203
- Status last verified
- Dec 2007
- First submitted
- 24 Apr 2006
- Last updated
- 10 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 75 mg and 150 mg Doses of ERB-041 on the Reduction of Symptoms Associated With Endometriosis During Treatment and Post Treatment in Reproductive-Aged Women
- ClinicalTrials.gov ID
- NCT00318500
- Acronym / sponsor ID
- 3142A2-203
- Conditions
- Dysmenorrhea, Dyspareunia, Endometriosis, Pelvic Pain
- Keywords
- Endometriosis, Dysmenorrhea, Pelvic pain, Dyspareunia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 26 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 evaluate the efficacy and safety of two doses of ERB-041 (75 mg and 150 mg) relative to placebo on the relief of endometriosis-related symptoms (dysmenorrhea, pelvic pain, and deep dyspareunia) in reproductive aged women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Surgical diagnosis of endometriosis within the last 10 years
- Sexually active, nonpregnant, nonlactating women (18-45 years) with regular menstrual cycles who are willing to use non-hormonal contraception
Key exclusion criteria (2 listed)
- Conditions requiring the use of chronic pain therapy
- Prophylactic use of analgesics to avoid endometriosis-related pain
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 |
|---|---|---|
| ERB-041 | Drug | – |
Primary outcome
severity scores for dysmenorrhea, pelvic pain and deep dyspareunia from baseline through 12 weeks of treatment using the B & B scale administered by the investigator
3 secondary outcomes
change in severity scores for pelvic tenderness and pelvic induration during 12 weeks of treatment
change in rescue medication use
change in health related quality of life questionnaires
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 10 Dec 2007.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager principal investigator
For United Kingdom, ukmedinfo@wyeth.com
Trial Manager principal investigator
For Australia and Hong Kong, medinfo@wyeth.com
70 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ERB-041 in people with Dysmenorrhea and Dyspareunia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 70 sites in 7 countries.
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 2 inclusion and 2 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 10 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United States, Canada, Australia, South Africa, United Kingdom and 2 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
severity scores for dysmenorrhea, pelvic pain and deep dyspareunia from baseline through 12 weeks of treatment using the B & B scale administered by the investigator. 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 10 Dec 2007.