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A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women

Primary Purpose

Amenorrhea, Postmenopause

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Asoprisnil/Premarin
Asoprisnil/Premarin
Asoprisnil/Premarin
Placebo and Premarin
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amenorrhea focused on measuring Postmenopausal, Amenorrhea, Hormone replacement therapy, HRT, asoprisnil

Eligibility Criteria

48 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Postmenopausal women with an intact uterus Body mass index (BMI) between 18.0 - 33.0 Good general health Endometrial thickness ≤ 4 mm by TVU No history or suspected endometrial hyperplasia Negative urine pregnancy test Pap smear in last 6 months with no evidence of malignancy or pre-malignant changes Mammogram without suspicion of malignancy within last 6 months Endometrial biopsy with no evidence of pathologic changes within last 6 months Exclusion Criteria: Any abnormal lab result the study-doctor considers significant History of severe reaction to hormone therapy Receiving hormone therapy Currently using phytoestrogenic compounds, such as red clover, black cohosh (Promensil and Remifemin), dong quai, ginseng and soy isoflavones History or known or suspected cancer other than basal cell carcinoma Stenosis of the cervix History of reproductive endocrine disorder Washout requirement for hormonal therapy not met Ovarian mass Submucus or other symptomatic fibroid which would confound efficacy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    3

    4

    Arm Description

    Outcomes

    Primary Outcome Measures

    Assessment of endometrium by endometrial biopsy
    Change from baseline in endometrial thickness as assessed by ultrasound

    Secondary Outcome Measures

    Frequency and amount of vaginal bleeding via patient diary.
    Incidence of hot flushes
    Presence or absence of endometrial hyperplasia.
    Response to global efficacy question regarding improvement in menopause symptoms.

    Full Information

    First Posted
    September 7, 2005
    Last Updated
    May 27, 2008
    Sponsor
    Abbott
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00152282
    Brief Title
    A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women
    Official Title
    A Phase II Pilot Study to Evaluate the Safety and Efficacy of J867 Administered With Estrogen to Postmenopausal Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2000 (undefined)
    Primary Completion Date
    August 2001 (Actual)
    Study Completion Date
    August 2001 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Abbott

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of this study is to determine the safety and effectiveness of 3 asoprisnil doses when administered to postmenopausal women with Premarin® 0.625 mg.
    Detailed Description
    The objective of this study is to determine the safety and effectiveness of asoprisnil 5, 10, and 25 mg, compared to placebo, when administered to postmenopausal women, with Premarin® 0.625 mg, for 12 weeks. Pharmacodynamic effects to be assessed include bleeding pattern, endometrial biopsy results, and endometrial thickness. Safety assessments will include clinical laboratory results, physical examination with vital signs, pelvic and breast examinations, ultrasound results, and adverse events

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Amenorrhea, Postmenopause
    Keywords
    Postmenopausal, Amenorrhea, Hormone replacement therapy, HRT, asoprisnil

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    105 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Experimental
    Arm Title
    3
    Arm Type
    Experimental
    Arm Title
    4
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Asoprisnil/Premarin
    Intervention Description
    Asoprisnil 5mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Asoprisnil/Premarin
    Intervention Description
    Asoprisnil 10mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Asoprisnil/Premarin
    Intervention Description
    Asoprisnil 25mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo and Premarin
    Intervention Description
    Placebo and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
    Primary Outcome Measure Information:
    Title
    Assessment of endometrium by endometrial biopsy
    Time Frame
    Week 12
    Title
    Change from baseline in endometrial thickness as assessed by ultrasound
    Time Frame
    Week 12
    Secondary Outcome Measure Information:
    Title
    Frequency and amount of vaginal bleeding via patient diary.
    Time Frame
    Week 4, 8, and 12
    Title
    Incidence of hot flushes
    Time Frame
    Week 4, 8, and 12
    Title
    Presence or absence of endometrial hyperplasia.
    Time Frame
    Week 12
    Title
    Response to global efficacy question regarding improvement in menopause symptoms.
    Time Frame
    Week 12

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    48 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Postmenopausal women with an intact uterus Body mass index (BMI) between 18.0 - 33.0 Good general health Endometrial thickness ≤ 4 mm by TVU No history or suspected endometrial hyperplasia Negative urine pregnancy test Pap smear in last 6 months with no evidence of malignancy or pre-malignant changes Mammogram without suspicion of malignancy within last 6 months Endometrial biopsy with no evidence of pathologic changes within last 6 months Exclusion Criteria: Any abnormal lab result the study-doctor considers significant History of severe reaction to hormone therapy Receiving hormone therapy Currently using phytoestrogenic compounds, such as red clover, black cohosh (Promensil and Remifemin), dong quai, ginseng and soy isoflavones History or known or suspected cancer other than basal cell carcinoma Stenosis of the cervix History of reproductive endocrine disorder Washout requirement for hormonal therapy not met Ovarian mass Submucus or other symptomatic fibroid which would confound efficacy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Abbott
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women

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