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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-000068-10
    Sponsor's Protocol Code Number:3142A2-203
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-05-17
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2006-000068-10
    A.3Full title of the trial
    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
    A.4.1Sponsor's protocol code number3142A2-203
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorWyeth Research Division of Wyeth Pharmaceuticals Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameERB-041
    D.3.2Product code ERB-041
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 524684-52-4
    D.3.9.2Current sponsor codeERB-041
    D.3.9.3Other descriptive nameWAY-202041
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Reproductive-aged women with moderate to severe symptoms related to endometriosis. Subjects will have been diagnosed with endometriosis by laparoscopy or laparotomy within 10 years before visit 1B (screening).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10014788
    E.1.2Term Endometriosis related pain
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -To evaluate the superiority of ERB-041 relative to placebo on the relief of endometriosis-related symptoms (dysmenorrhea, pelvic pain, and deep dyspareunia) in reproductive-aged women using the Biberoglu & Behrman (B&B) scale administered by the physician investigator.
    -To compare the safety profile of ERB-041 with placebo during 12 weeks of treatment.
    E.2.2Secondary objectives of the trial
    Compare ERB-041 with placebo:
    Treatment Phase:
    -Clinical assessment of endometriosis using B&B scale
    -Subject assessment of symptoms using 11-point daily subject-reported severity scale
    -Assessment of change in subject-reported use of rescue medication
    -Evaluation of number of subject withdrawals secondary to symptoms associated with endometriosis
    -Assessment of HRQL measured by the EHP-30 questionnaire
    -Pharmacokinetic analysis
    Pilot and validate administration of:
    -Novel daily subject assessment instrument to measure symptoms associated with endometriosis
    -Novel subject assessment instrument to measure subject satisfaction with treatment
    Post-treatment Phase:
    -Evaluation of number of subjects whose symptoms recur and time to recurrence
    -Clinical assessment of endometriosis using criteria from the B&B scale
    -Subject assessment of symptoms using a daily subject-reported 11-point severity scale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must have had a surgical diagnosis (laparoscopy or laparotomy) of endometriosis established within 10 years before visit 1B (screening). Operative report review will be required for verification. If multiple surgeries have been performed within the previous 10 years, the operative report of the most recent laparoscopy or laparotomy will be used for eligibility requirements and source documentation.
    ·-Subjects must be nonpregnant, nonlactating women aged 18 to 45 years, inclusive, at the time of visit 1B (screening).
    ·- Subjects not undergoing a washout from oral contraceptives must have a history of regular menstrual periods (3 or more consecutive days of uterine bleeding requiring sanitary protection), with cycle lengths of 21 to 35 days, for at least 3 consecutive months before visit 1B (screening).
    ·- After discontinuation of oral contraceptives, subjects must have had 1 spontaneous period (ie, after the oral contraceptives withdrawal bleed) before visit 1B (screening).
    ·- Subjects must be sexually active (vaginal intercourse). “Sexually active” is defined as full vaginal penetration at least 2 times per month or 2 failed attempts at vaginal intercourse.
    ·- Subjects must be willing to use highly effective nonhormonal methods of birth control (eg, sterilization, diaphragm with spermicide, or condom with spermicide) for the duration of study participation.
    ·- Subject must have a telephone line (analog preferred) or wireless communication instrument.
    ·- Subject should be able to understand the use of a personal digital assistant (PDA) device.
    ·- In the opinion of the investigator, the subject will comply with the protocol and has a high probability of completing the study.
    ·- Subjects must be willing to refrain from the use of prohibited medications during the treatment and posttreatment phases of the study.
    ·- During the treatment phase, subjects must be willing to use no more than the rescue medication regimen historically established during the pretreatment phase.
    ·- Rescue medication is limited to intake of 1 dose of analgesic per episode. If pain recurs, the subject is permitted to take a dose for each recurring episode up to the daily recommended dose for that rescue medication. Chronic narcotic use is not permitted.
    ·- Subjects must exhibit a positive response regarding the symptom of pelvic pain. A positive response is reported by the subject, reflects the worst episode before analgesic use, and is determined as follows:
    o At Visit 1B (Screening):
    i. Subjects must have moderate to severe pelvic pain for at least 3 months before visit 1B (screening), as exhibited by a pelvic pain score of 3 or 4 on the B&B scale (the B&B scale includes the symptom of pelvic pain and assigns a point score for the degree of reported severity); AND
    ii. The subject must report a pelvic pain score of at least 4 on the numeric rating scale (NRS, question 3) included in the Pelvic Pain Classification Tool (PPCT) on the basis of 1-month recall of the severity of her nonmenstrual pelvic pain before taking pain medication (if applicable).
    o At Visit 2 (Randomization):
    i. The subject must have a pelvic pain score of 3 or 4 on the B&B scale (this pelvic pain score will be considered baseline); AND
    ii. The subject must report a pelvic pain score of at least 4 on the NRS on the basis of 1-month recall of the severity of her nonmenstrual pelvic pain before taking pain medication (if applicable).
    ·- Subjects must sign and date an institutional review board (IRB)-approved written informed consent form before any screening procedures are performed.
    E.4Principal exclusion criteria
    Subjects who desire to become pregnant during the study.
    - Subjects who have undergone hysterectomy and/or bilateral oophorectomy
    - Subjects who are not candidates for estrogen therapy.
    - Subjects who are pregnant or who were pregnant before visit 1B (screening).
    - Subjects who are breastfeeding.
    - Subjects who are not sexually active.
    - The use of the following drugs within 30 days before visit 1B (screening):
    a. Oral contraceptives, dermal patch containing contraceptives, injectable or implantable or insertable contraceptive hormones.
    b. Oral, transdermal, or vaginally applied estrogens, progestogens, and/or androgens.
    c. Aromatase inhibitors (eg, anastrozole).
    - The use of the following drugs within 90 days before visit 1B (screening):
    a. Progestin containing intrauterine device (IUD).
    b. Monthly dose gonadotropin-releasing hormone (GnRH) analogs (eg, leuprolide acetate, 3.75 mg formulation).
    c. Use of psychoactive medications (eg, selective serotonin reuptake inhibitors [SSRIs], serotonin norepinephrine reuptake inhibitors [SNRIs], tricyclic antidepressants), if used for chronic pain.
    d. Use of selective estrogen receptor modulators (SERMs), including raloxifene, tamoxifen, and clomiphene.
    - The use of the following drugs within 10 months before visit 1B (screening):
    a. Injectable/implantable progestogens (eg, medroxyprogesterone acetate depot formulation).
    b. Three (3)-month dose GnRH analogs (eg, leuprolide acetate, 11.25 mg formulation).
    - Use of antiepileptic medications (eg, carbamazepine, gabapentin, lamotrigine).
    - Transvaginal ultrasound (TVUS) findings requiring immediate surgical intervention, as determined by the investigator, and/or evidence of findings indicative of a secondary cause of pelvic pain other than endometriosis.
    - A history of endometriosis-related symptoms that are completely relieved by mild analgesics.
    - Abnormal cervical cytology smear (based on the Bethesda 2001 system). Subjects with reported atypical squamous cells of undetermined significance (ASCUS) may be considered if human papilloma virus (HPV) result is negative.
    - Presence or history of the following:
    a. Pelvic pain secondary to other disease processes (eg, pelvic masses other than endometriomas, genitourinary disease, fibromyalgia, pelvic inflammatory disease, gastrointestinal disease, irritable bowel syndrome).
    b. Known history of or suspected endometrial hyperplasia or carcinoma.
    c. Thrombophlebitis, thrombosis or thromboembolic disorders, deep vein thrombosis, pulmonary embolism, or known coagulopathy.
    d. Ischemic heart disease, myocardial infarction, or unstable angina within 6 months before screening.
    e. Cerebrovascular or cardiovascular disease.
    f. Neuro-ocular disorders (eg, optic neuritis or retinal vein thrombosis).
    g. Cholestasis or symptomatic gallstones (subjects who have had a cholecystectomy may be enrolled).
    h. Valvular heart disease.
    i. Breast cancer.
    j. Estrogen-dependent neoplasia (eg, endometrial carcinoma, melanoma).
    k. Liver tumors (benign or malignant).
    l. Diabetes with vascular involvement, or uncontrolled diabetes.m. Undiagnosed abnormal genital bleeding within the past 6 months.
    - Presence of the following:
    a. Abnormality suggestive of malignancy noted on mammogram, breast examination, and/or ultrasound findings.
    b. Malignancy, or treatment for malignancy, within the previous 10 years. History or active presence of basal cell or squamous cell carcinoma of the skin does not exclude the subject. History of nonmelanoma skin cancer does not exclude the subject.
    c. Body mass index (BMI) above 40 kg/m2.
    d. Persistent elevated blood pressure. Elevated blood pressure is defined as >140 mm Hg systolic or >90 mm Hg diastolic on hypertensive therapy when meas ured after the subject sits for 3 minutes.
    e. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) values ≥1.5 times the upper limit of normal (ULN) for the laboratory used.
    f. Serum creatinine value ≥1.5 times the ULN for the laboratory used.
    g. Alkaline phosphatase value ≥1.5 times the ULN for the laboratory used.
    h. Total bilirubin value ≥1.5 times the ULN for the laboratory used. Subjects with a preexisting diagnosis of Gilbert’s syndrome may be included after approval by the Wyeth Research (WR) medical monitor.
    i. Fasting total cholesterol value ≥250 mg/dL ( ≥6.5 mmol/L) or triglycerides value ≥250 mg/dL ( ≥2.8 mmol/L).
    j. Fasting blood glucose ≥125 mg/dL (≥6.9 mmol/L).
    k. Positive cervical cultures for gonorrhea or Chlamydia infection. Subjects with positive culture results may be treated and, if repeat results are negative, allowed into the study.
    l. Headaches with focal neurologic symptoms.
    m. Planned major surgery requiring immobilization.
    - Known alcohol or drug abuse.
    - Presence of a malabsorption disorder.
    - Clinically important abnormalities on initial physical examination or pretreatment laboratory tests.
    E.5 End points
    E.5.1Primary end point(s)
    The change in individual severity scores for the 3 symptoms of endometriosis (dysmenorrhea, pelvic pain, and deep dyspareunia [co-primary endpoints]) from baseline to last on-therapy cycle based on the B&B scale administered by the physician investigator.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-05-17. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 150
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Post-treatment phone calls approx 15, 28, and 56 days after last day of test article intake to obtain information about any worsening of the subject’s condition, any new or persistent adverse events, any medications/treatments, any symptoms/complaints. During post-treatment phase of study, medications to treat endometriosis pain are permitted. The Investigator will counsel subject on available therapies for treatment of endometriosis.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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