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EndometriosisPhase 2NCT00110487

Study Evaluating ERB-041 in Endometriosis in Reproductive-Age Women

A Phase 2 study testing ERB-041 in people with Endometriosis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 46 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this investigational study is to determine if a study medication is safe and effective in reducing the symptoms associated with endometriosis; if the study medication reduces the need for pain medication for endometriosis symptoms; and if the study medication improves a participant's ability to carry… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Endometriosis
What is being tested?
ERB-041
How many people
200 participants
Where
46 sitesUnited States
Study dates
Jan 2005to 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 5 years
  • Not pregnant and not lactating
  • Willing to use non-hormonal contraception, history of regular menstrual cycles

Who cannot join

  • Hysterectomy, surgical treatment for endometriosis within 3 months
  • Certain medications for the treatment of endometriosis
  • Previous history of a malignancy
  • Abnormalities on physical or gyn exams and abnormal lab tests

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

United States46 sites

  • Study site

    Alpharetta, Georgia, 30005

  • Study site

    Arlington Heights, Illinois, 60005

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Aventura, Florida, 33180

  • Study site

    Berlin, New Jersey, 08009

  • Study site

    Boynton Beach, Florida, 33437

  • Study site

    Carmichael, California, 95608

  • Study site

    Celebration, Florida, 34747

  • Study site

    Champaign, Illinois, 61820

  • Study site

    Charlotte, North Carolina, 28209

  • Study site

    Chaska, Minnesota, 55318

  • Study site

    Chesterfield, Missouri, 63017

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Cincinnati, Ohio, 45267

  • Study site

    Clearwater, Florida, 33758

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Dallas, Texas, 75390-9032

  • Study site

    Detroit, Michigan, 48201

  • Study site

    Eugene, Oregon, 97401

  • Study site

    Fargo, North Dakota, 58104

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Greenville, South Carolina, 29605

  • Study site

    Greer, South Carolina, 29651

  • Study site

    La Jolla, California, 92093

  • Study site

    Lakewood, Colorado, 80228

  • Study site

    Lanham, Maryland, 20706

  • Study site

    Las Vegas, Nevada, 89104

  • Study site

    Laurel, Maryland, 20707

  • Study site

    Madison, Wisconsin, 53792-6188

  • Study site

    Miami, Florida, 33136

  • Study site

    Miami, Florida, 33143

  • Study site

    New Port Richey, Florida, 34652

  • Study site

    Norfolk, Virginia, 23507-1627

  • Study site

    Oak Brook, Illinois, 60523

  • Study site

    Ocala, Florida, 34471

  • Study site

    Palm Harbor, Florida, 34684

  • Study site

    Phoenix, Arizona, 85015

  • Study site

    Redding, California, 96001

  • Study site

    Richmond, Virginia, 23298

  • Study site

    San Diego, California, 92123

  • Study site

    Sandy City, Utah, 84070

  • Study site

    Shreveport, Louisiana, 71103

  • Study site

    South Bend, Indiana, 46601

  • Study site

    Tucson, Arizona, 85710

  • Study site

    Webster, Texas, 77598

Other trials in United States

About this study

Official title: A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study of the Effect of ERB-041 in the Reduction of Symptoms Associated With Endometriosis in Reproductive-Age Women

The purpose of this investigational study is to determine if a study medication is safe and effective in reducing the symptoms associated with endometriosis; if the study medication reduces the need for pain medication for endometriosis symptoms; and if the study medication improves a participant's ability to carry out daily activities. Qualified participants will receive no cost treatment, which may include study-related examinations, diagnostic procedures including a Pap smear, laboratory testing, and a mammogram (aged 40-45). Qualified participants will also receive study medication at no cost. As a participant, the study volunteer may also experience the satisfaction of knowing she is helping the advancement of women's health care.

Conditions
Endometriosis
Being tested
ERB-041
Keywords
Endometriosis
Medical subject headings
Endometriosis

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.

  1. To assess the effects and to compare the safety profile of an investigational

  2. medication on the relief of endometriosis-related symptoms.

Secondary outcomes (2)

  1. Clinical and subject assessment of symptoms related to endometriosis and the

  2. use of analgesia to relieve symptoms.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2005 (estimated)
  2. Study startJan 2005
  3. Study completionDec 2006

Resources

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
Single group
Masking
Double blind
Enrolment
200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00110487
Sponsor's protocol ID
3142A2-200
Status last verified
Dec 2007
First submitted
9 May 2005
Last updated
1 May 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ERB-041 in people with Endometriosis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 46 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 3 inclusion and 4 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 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 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 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?

To assess the effects and to compare the safety profile of an investigational. 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?

On the ClinicalTrials.gov record for NCT00110487.

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 1 May 2015.

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