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An Open-Label Study to Compare the Bleeding Profile of Norelgestromin/Ethinyl Estradiol in an Extended Regimen to Norelgestromin/Ethinyl Estradiol Given in a Traditional Regimen

Primary Purpose

Metrorrhagia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
norelgestromin/ethinyl estradiol
Sponsored by
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metrorrhagia focused on measuring Metrorrhagia, oral contraception, breakthrough bleeding, spotting

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Patients in good health as confirmed by medical history not pregnant as demonstrated by negative urine pregnancy test completed their last term pregnancy at least 42 days prior to Screening and at least one normal menstrual period since last pregnancy not lactating post-menarcheal and pre-menopausal Exclusion Criteria: History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy including but not limited to the following - active or history of deep vein thrombophlebitis or thromboembolytic disorders or hypercoagulation disorders, cerebral vascular or coronary artery disease, uncontrolled hypertension, or migraines with focal aura, benign or malignant liver tumor which developed during the use of oral contraceptives or estrogen-containing products treatment with continuous oral contraception within three months of study previous use of contraceptive patch including norelgestromin/ethinyl estradiol patients who are amenorrheic (abnormal suppression or absence of menstruation) recent history of alcohol or substance abuse skin conditions resulting in oily, irritated or damaged skin at potential sites of application

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    001

    Arm Description

    norelgestromin/ethinyl estradiol

    Outcomes

    Primary Outcome Measures

    The primary efficacy variables are the total number bleeding and/or spotting days during the 84-day reference period and the number of bleeding and/or spotting episodes during the 84-day reference period.

    Secondary Outcome Measures

    Secondary efficacy variables include the number of breakthrough bleeding and/or spotting days per 28-day interval, the number of breakthrough bleeding days per 28-day interval, time to first bleeding and/or spotting, duration of menses.

    Full Information

    First Posted
    April 28, 2006
    Last Updated
    June 30, 2011
    Sponsor
    McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00320580
    Brief Title
    An Open-Label Study to Compare the Bleeding Profile of Norelgestromin/Ethinyl Estradiol in an Extended Regimen to Norelgestromin/Ethinyl Estradiol Given in a Traditional Regimen
    Official Title
    A Randomized, Open-Label, Multicenter Study Comparing the Bleeding Profile of Ortho Evra (Norelgestromin/Ethinyl Estradiol) Continuous Regimen vs. Ortho Evra Cyclic Regimen
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the bleeding profile of norelgestromin/ethinyl estradiol given in an extended continuous regimen to norelgestromin/ethinyl estradiol given in a traditional cyclic regimen
    Detailed Description
    Norelgestromin/ethinyl estradiol is a contraceptive patch shown to be safe and effective for the prevention of pregnancy. The usual treatment regimen is three consecutive seven-day patches followed by one patch-free week. This cyclic method is followed in order to mimic the 28-day menstrual cycle. An extended contraceptive regimen (administration of active hormones for greater than 21 days) of oral contraceptives is a common practice among women wishing to delay or prevent withdrawal bleeding for reasons such as athletic participation or going on vacation. In addition to the convenience of reducing the frequency of withdrawal bleeds, elimination of the hormone-free interval reportedly reduces many menstrually-related symptoms (headaches, pelvic pain, breast tenderness, bloating, swelling) that occur at a greater frequency during the hormone-free interval than during the rest of the cycle. Headache is one of the most common adverse effects associated with hormonal contraceptive use. Studies have demonstrated that headaches were reduced in subjects using extended intervals of active hormone. However, one of the main side effects reported with extended regimens is breakthrough bleeding and/or spotting. Compared to cyclic regimens, extended oral contraceptive use may be associated with an increased incidence of breakthrough bleeding and spotting, especially during the first few months of use. This is a randomized (patients are assigned different treatments based on chance), open-label, multicenter study comparing the bleeding profile of norelgestromin/ethinyl estradiol patch continuous regimen to norelgestromin/ethinyl estradiol patch cyclic regimen. Safety evaluations include adverse event reporting, physical examinations, blood levels, and vital signs. The hypothesis of the study is that norelgestromin/ethinyl estradiol in an extended regimen of 84 days of active hormone would result in fewer days and episodes of bleeding compared to a traditional cyclic regimen of norelgestromin/ethinyl estradiol. Patients receive norelgestromin/ethinyl estradiol patches in a plastic sleeve. In the extended regimen patches will be applied weekly for 12 consecutive weeks followed by one week patch-free and then another three consecutive weeks of weekly patch applications. In the cyclic regimen patches will be applied for four consecutive cycles where each cycle consists of three weekly patch applications followed by one week patch-free. The total duration of treatment period is 112 days for each regimen.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metrorrhagia
    Keywords
    Metrorrhagia, oral contraception, breakthrough bleeding, spotting

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    239 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    001
    Arm Type
    Experimental
    Arm Description
    norelgestromin/ethinyl estradiol
    Intervention Type
    Drug
    Intervention Name(s)
    norelgestromin/ethinyl estradiol
    Primary Outcome Measure Information:
    Title
    The primary efficacy variables are the total number bleeding and/or spotting days during the 84-day reference period and the number of bleeding and/or spotting episodes during the 84-day reference period.
    Secondary Outcome Measure Information:
    Title
    Secondary efficacy variables include the number of breakthrough bleeding and/or spotting days per 28-day interval, the number of breakthrough bleeding days per 28-day interval, time to first bleeding and/or spotting, duration of menses.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients in good health as confirmed by medical history not pregnant as demonstrated by negative urine pregnancy test completed their last term pregnancy at least 42 days prior to Screening and at least one normal menstrual period since last pregnancy not lactating post-menarcheal and pre-menopausal Exclusion Criteria: History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy including but not limited to the following - active or history of deep vein thrombophlebitis or thromboembolytic disorders or hypercoagulation disorders, cerebral vascular or coronary artery disease, uncontrolled hypertension, or migraines with focal aura, benign or malignant liver tumor which developed during the use of oral contraceptives or estrogen-containing products treatment with continuous oral contraception within three months of study previous use of contraceptive patch including norelgestromin/ethinyl estradiol patients who are amenorrheic (abnormal suppression or absence of menstruation) recent history of alcohol or substance abuse skin conditions resulting in oily, irritated or damaged skin at potential sites of application
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial
    Organizational Affiliation
    McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15932834
    Citation
    Stewart FH, Kaunitz AM, Laguardia KD, Karvois DL, Fisher AC, Friedman AJ. Extended use of transdermal norelgestromin/ethinyl estradiol: a randomized trial. Obstet Gynecol. 2005 Jun;105(6):1389-96. doi: 10.1097/01.AOG.0000160430.61799.f6.
    Results Reference
    result
    PubMed Identifier
    15950671
    Citation
    LaGuardia KD, Fisher AC, Bainbridge JD, LoCoco JM, Friedman AJ. Suppression of estrogen-withdrawal headache with extended transdermal contraception. Fertil Steril. 2005 Jun;83(6):1875-7. doi: 10.1016/j.fertnstert.2004.12.048.
    Results Reference
    result

    Learn more about this trial

    An Open-Label Study to Compare the Bleeding Profile of Norelgestromin/Ethinyl Estradiol in an Extended Regimen to Norelgestromin/Ethinyl Estradiol Given in a Traditional Regimen

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