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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00152282
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : May 29, 2008
Sponsor:
Information provided by:
Abbott

Tracking Information
First Submitted Date  ICMJE September 7, 2005
First Posted Date  ICMJE September 9, 2005
Last Update Posted Date May 29, 2008
Study Start Date  ICMJE September 2000
Actual Primary Completion Date August 2001   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2007)
  • Assessment of endometrium by endometrial biopsy [ Time Frame: Week 12 ]
  • Change from baseline in endometrial thickness as assessed by ultrasound [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
The percent of subjects in each endometrial biopsy diagnostic category, mean change from baseline to final visit in endometrial thickness, and cumulative rates and incremental incidence rate of vaginal bleeding (bleeding, spotting, and amenorrhea).
Change History Complete list of historical versions of study NCT00152282 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2008)
  • Frequency and amount of vaginal bleeding via patient diary. [ Time Frame: Week 4, 8, and 12 ]
  • Incidence of hot flushes [ Time Frame: Week 4, 8, and 12 ]
  • Presence or absence of endometrial hyperplasia. [ Time Frame: Week 12 ]
  • Response to global efficacy question regarding improvement in menopause symptoms. [ Time Frame: Week 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
Secondary outcomes in this study will be percent of total bleeding days, mean number of moderate to severe hot flush, and mean weekly hot flush scores, etc.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women
Official Title  ICMJE A Phase II Pilot Study to Evaluate the Safety and Efficacy of J867 Administered With Estrogen to Postmenopausal Women
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Amenorrhea
  • Postmenopause
Intervention  ICMJE
  • Drug: Asoprisnil/Premarin
    Asoprisnil 5mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
  • Drug: Asoprisnil/Premarin
    Asoprisnil 10mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
  • Drug: Asoprisnil/Premarin
    Asoprisnil 25mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
  • Drug: Placebo and Premarin
    Placebo and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Asoprisnil/Premarin
  • Experimental: 2
    Intervention: Drug: Asoprisnil/Premarin
  • Experimental: 3
    Intervention: Drug: Asoprisnil/Premarin
  • Placebo Comparator: 4
    Intervention: Drug: Placebo and Premarin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2007)
105
Original Enrollment  ICMJE
 (submitted: September 7, 2005)
100
Actual Study Completion Date  ICMJE August 2001
Actual Primary Completion Date August 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 48 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00152282
Other Study ID Numbers  ICMJE M00-198
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cynthia Mattia-Goldberg, Abbott
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Medical Director Abbott
PRS Account Abbott
Verification Date May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP