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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2005-004978-25
    Sponsor's Protocol Code Number:300
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2006-07-19
    Trial 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 ConcernedSweden - MPA
    A.2EudraCT number2005-004978-25
    A.3Full title of the trial
    A multicenter, open-label study on the efficacy, cycle control and safety of a contraceptive
    vaginal ring delivering a daily dose of 150 µg of Nestorone(R) and 15 µg of ethinyl estradiol (150/15 NES/EE CVR)
    A.4.1Sponsor's protocol code number300
    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 SponsorInternational Committee for Contraception Research of the Population Council
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 nameNestorone®/Ethinyl Estradiol Contraceptive Vaginal Ring
    D.3.2Product code 150/15 NES/EE CVR
    D.3.4Pharmaceutical form Vaginal delivery system
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNethinylestradiol
    D.3.9.1CAS number 57-63-6
    D.3.9.2Current sponsor codeEE
    D.3.9.3Other descriptive name17α-ethynyl-1,3,5(10) estriene-3, 17β-diol
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number17.4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 7759-35-5
    D.3.9.2Current sponsor codeNestorone, NES; ST 1435
    D.3.9.3Other descriptive name16-methylene-17α-acetoxy-19-nor-pregn-4-ene-3,20 dione
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number103
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    As the trial is intended to investigate a new contraceptive medicinal product, the study subjects included are not characterized by a specific medical condition.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10010808
    E.1.2Term Contraception
    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 one-year data on the contraceptive efficacy and safety of the 150/15 NES/EE CVR as the basis for regulatory approvals of this CVR as a new delivery system for contraception.
    E.2.2Secondary objectives of the trial
    To evaluate the cycle control, bleeding patterns, side effects, and acceptability of a 21-day continuous use regimen of the CVR, followed by one week off per cycle.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A multicenter, open-label study on the acceptability of a contraceptive vaginal ring delivering a daily dose of 150 mg of Nestorone and 15 mg of Ethinyl estradiol (150/15 NES/EE CVR): An addendum to Protocol 300 A/B: A multicenter, open-label study on the efficacy, cycle control and safety of a contraceptive vaginal ring delivering a daily dose of 150µg of Nestorone and 15 mg of Ethinyl estradiol (150/15 NES/EE CVR). Date and Version are the same as for the main study protocol.
    Primary Objective: To evaluate method acceptability among women who are enrolled in the phase 3 safety and efficacy trial for the 150/15 µg NES/EE CVR.

    Secondary Objectives:
    a) To determine characteristics of women who are satisfied and successful users of the CVR;
    b) To determine characteristics and properties of the NES/EE CVR that appeal to women and their partners seeking contraception including affects on sexual activity:
    c) To describe women’s’ perspectives regarding use of vaginal rings to deliver other therapies important to women’s health, e.g. anti-infective agents.
    E.3Principal inclusion criteria
    a. Healthy women, aged 18-<40 years at the enrollment visit who wish to use a combined hormonal contraceptive
    b. Women not intending to become pregnant before December 31, 2008
    c. Intact uterus and both ovaries.
    d. Prior history of regular menstrual cycles that usually occur every 28 ± 7 days when not using hormonal contraception; if postpartum or postabortal, history of regular menstrual cycles of 21-35 days in length and resumption of at least one cycle with a cycle length consistent with her past cycles.
    e. Sexually active (currently) and willing to discontinue current contraceptive method to participate in the study.
    f. In the opinion of the investigator, able to comply with the protocol, e.g. live within the clinic catchment area or within a reasonable distance from the clinic.
    g. Do not meet any of the exclusion criteria.
    h. Signed informed consent prior to entry into the trial.
    Amd9-EX: i. Completion of 13 cycles in Protocol 300B immediately prior to entry in the
    E.4Principal exclusion criteria
    a. Known hypersensitivity to estrogens or progestins
    b. Known hypersensitivity to silicone rubber.
    c. Known or suspected pregnancy.
    d. History of infertility of >1.0 year in woman or her male partner.
    e. History of vasectomy or sterility in male partner; tubal ligation (sterilization) in women.
    f. Undiagnosed abnormal genital bleeding.
    g. Undiagnosed vaginal discharge or vaginal lesions or abnormalities.
    h. History of pelvic inflammatory disease since last pregnancy episode.
    i. History of toxic shock syndrome.
    j. In accordance with the Bethesda system of classification: Women with a current abnormal Pap smear suggestive of high-grade pre-cancerous lesion (s), including HGSIL, are excluded;
    · Women with LGSIL or ASCUS/high-risk HPV positive may participate if further evaluated with colposcopy and biopsy and no evidence of a lesion with a severity > CIN I is present and/or endocervical curettage is negative.
    · Women with a biopsy finding of CIN I should have follow up for this finding per standard of care; women are excluded it treatment is indicated.
    In accordance with other Pap class systems:
    · Women with high grade dysplasia are excluded.
    · Women with low grade dysplasia or CIN I interpretation on Pap smear may participate if further evaluated with colposcopy and, as needed, biopsy with endocervical curettage.
    · Women may participate if colposcopy findings are negative provided there is appropriate follow up in accordance with local standards of care;
    · Women whose colposcopy results indicate need for biopsy may participate as long as biopsy results indicate there is no lesion with a severity > CIN I and endocervical curettage results are negative.
    k. Cystoceles or rectoceles or other anatomical abnormality that would preclude use of a vaginal ring.
    l. Women planning to undergo major surgery.
    m. Smoking in women who are 35 years and over or will be 35 years during the course of the trial; women < 35yrs who smoke 15 cigarettes or more per day must be evaluated by the PI for inclusion based on risk factors that would increase their risk for CVD and thromboembolism, e.g. lipid levels, glucose level, BP, BMI, family history of CVD at a young age.
    n. Breastfeeding.
    o. Current or past thrombophlebitis or thromboembolic disorders.
    p. History of venous thrombosis or embolism in a first-degree relative, <55 years of age suggesting a familial defect in the blood coagulation system, which in the opinion of the PI, suggests use of a hormonal contraceptive could pose a significant risk.
    q. Cerebrovascular or cardiovascular disease.
    r. History of retinal vascular lesions, unexplained partial or complete loss of vision.
    s. Known or suspected carcinoma of the breast.
    t. Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.
    u. Past history of any other carcinoma unless in remission for more than 5 years.
    v. Current or history of medically diagnosed severe depression, which, in the opinions of the investigator, could be exacerbated by use of a hormonal contraceptive.
    w. Headaches with focal neurological symptoms.
    x. Severe constipation.
    y. History of cholestatic jaundice of pregnancy or jaundice with prior steroid use.
    z. Benign or malignant liver tumors; active liver disease.
    aa. Diastolic blood pressure (BP) >85 mm Hg and/or systolic BP >135 mm Hg after 5-10 minutes rest.
    bb. Known or suspected alcoholism or drug abuse.
    cc. Abnormal serum chemistry values according to the physician’s judgment.
    dd. Participation in another clinical trial involving an investigational drug within last 30 days (prior to screening),
    ee. BMI >29.
    ff. Use of liver enzyme inducers on a regular basis.
    gg. Use of monthly injectable contraceptives (e.g. cyclofem) unless suspended 2 months before initiation of treatment. Use of Depo-Provera [depo-medroxyprogesterone (DMPA)] unless suspended 6 months before treatment.
    hh. Current use of implanted hormonal contraceptives
    ii. Current use of a non-hormonal IUD. Subjects with IUDs who request removal for reasons unrelated to the purpose of enrollment in this study may be considered for participation.
    jj. Known HIV infection.
    kk. Women at high risk of contracting HIV
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the Pearl Index per 100 woman years for women <= 35 years.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 Yes
    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
    The end of the study will be when the last subject enrolled in Protocol 300A or 300B has completed her last visit or follow-up period.
    This definition is preferred to the definition that the end of the study is the last visit of the last subject undergoing the trial in an EU member state because that might mean to prepare a report on the subsection of the data collected from a subset of participating states, where a final report based on the data of the whole trial is more appropriate.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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 Yes
    F.3.2Patients No
    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 2006-07-19. 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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 2200
    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)
    This issue is described in section 13.4 of the study protocol.
    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 Decision2006-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-22
    P. End of Trial
    P.End of Trial StatusOngoing
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