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An Open-Label Study Evaluating Breakthrough Bleeding and Spotting With Norgestimate/Ethinyl Estradiol Tablets Administered as an Extended Regimen

Primary Purpose

Metrorrhagia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Norgestimate/Ethinyl Estradiol tablet
Sponsored by
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Subjects in good health as confirmed by medical history, physical exam, and PAP smear within the preceding six months Non-smokers, if between 35 and 45 years of age Patients who are not pregnant or lactating Had at least one normal menstrual period within 35 days prior to screening Completed their last term pregnancy at least 42 days prior to screening and had at least one normal menstrual period since the last pregnancy Must be post-menarcheal (have had at least one normal menstrual period) and pre-menopausal (having regular menstrual periods) Exclusion Criteria: History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy, eg, menopause, active or history of deep vein thrombophlebitis, thromboembolic disorders or hypercoagulation disorders, cerebral vascular or coronary artery disease, uncontrolled hypertension, or migraines with focal aura, benign or malignant liver tumor that developed during the use of oral contraceptives or estrogen-containing products carcinoma of any body system, diabetes mellitus with vascular involvement, known or suspected estrogen-dependent neoplasia, cholestatic jaundice, undiagnosed abnormal vaginal bleeding, neurovascular lesion of the eye, clinically relevant impairment of liver function, liver disease or renal disease absence of cyclic bleeding for at least three months, recent history of alcohol or other substance abuse significant depression or psychiatric disease that would result in an unreliable patients any subject deemed by the investigator to have questionable reliability in her ability to comply with the protocol and provide accurate information.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The primary efficacy variables include the number of breakthrough bleeding and/or spotting days during the extended regimen treatment phase and the number of breakthrough bleeding days during the extended regimen treatment phase.

    Secondary Outcome Measures

    Secondary efficacy variables include the number of bleeding and/or spotting days, number of bleeding days, number of bleeding and/or spotting episodes, and number of bleeding episodes during both treatment regimens

    Full Information

    First Posted
    June 23, 2006
    Last Updated
    March 3, 2011
    Sponsor
    McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00344383
    Brief Title
    An Open-Label Study Evaluating Breakthrough Bleeding and Spotting With Norgestimate/Ethinyl Estradiol Tablets Administered as an Extended Regimen
    Official Title
    An Open-Label Study Evaluating the Bleeding Profile of Ortho Tri-Cyclen Lo (Norgestimate/Ethinyl Estradiol) Administered as an Extended Regimen
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2004 (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 evaluate the bleeding profile of norgestimate/ethinyl estradiol, an oral contraceptive tablet, given in an extended regimen
    Detailed Description
    This is an open-label study evaluating the bleeding profile of norgestimate/ethinyl estradiol tablets administered as an extended regimen (84 consecutive days of active tablets followed by seven days medication free) following a traditional regimen of two 28-day cycles (21 days of active tablets, followed by seven days of placebo tablets) of norgestimate/ethinyl estradiol tablets. All patients will receive norgestimate/ethinyl estradiol tablets in a traditional regimen for two 28-day cycles. Following the Traditional Treatment Phase, all patients will receive norgestimate/ethinyl estradiol tablets in an Extended Regimen Treatment Phase, consisting of 84 days of treatment with norgestimate/ethinyl estradiol tablets. Safety evaluations include physical examinations, adverse event reporting and vital signs. The hypothesis of the study is that a triphasic extended regimen would not result in breakthrough bleeding and spotting when the progestin dose drops. Traditional Regimen: two 28 day cycles of norgestimate 180 mcg daily for 1 week, 215 mcg daily for 1 week, 250 mcg daily for 1 week, placebo daily for 1 week. Extended Regimen: four uninterrupted cycles of norgestimate 180 mcg daily for 1 week, 215 mcg daily for 1 week, 250 mcg daily for 1 week, 1 week medication-free. In both Treatment Regimens patients receive ethinyl estradiol 25 mcg in each active tablet. The study is 147 days, Traditional days 1-56 and Extended days 57-147

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    61 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Norgestimate/Ethinyl Estradiol tablet
    Primary Outcome Measure Information:
    Title
    The primary efficacy variables include the number of breakthrough bleeding and/or spotting days during the extended regimen treatment phase and the number of breakthrough bleeding days during the extended regimen treatment phase.
    Secondary Outcome Measure Information:
    Title
    Secondary efficacy variables include the number of bleeding and/or spotting days, number of bleeding days, number of bleeding and/or spotting episodes, and number of bleeding episodes during both treatment regimens

    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: Subjects in good health as confirmed by medical history, physical exam, and PAP smear within the preceding six months Non-smokers, if between 35 and 45 years of age Patients who are not pregnant or lactating Had at least one normal menstrual period within 35 days prior to screening Completed their last term pregnancy at least 42 days prior to screening and had at least one normal menstrual period since the last pregnancy Must be post-menarcheal (have had at least one normal menstrual period) and pre-menopausal (having regular menstrual periods) Exclusion Criteria: History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy, eg, menopause, active or history of deep vein thrombophlebitis, thromboembolic disorders or hypercoagulation disorders, cerebral vascular or coronary artery disease, uncontrolled hypertension, or migraines with focal aura, benign or malignant liver tumor that developed during the use of oral contraceptives or estrogen-containing products carcinoma of any body system, diabetes mellitus with vascular involvement, known or suspected estrogen-dependent neoplasia, cholestatic jaundice, undiagnosed abnormal vaginal bleeding, neurovascular lesion of the eye, clinically relevant impairment of liver function, liver disease or renal disease absence of cyclic bleeding for at least three months, recent history of alcohol or other substance abuse significant depression or psychiatric disease that would result in an unreliable patients any subject deemed by the investigator to have questionable reliability in her ability to comply with the protocol and provide accurate information.
    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

    Learn more about this trial

    An Open-Label Study Evaluating Breakthrough Bleeding and Spotting With Norgestimate/Ethinyl Estradiol Tablets Administered as an Extended Regimen

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