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A Long-Term Study to Evaluate the Safety 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: NCT00152295
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : May 29, 2008
Sponsor:
Information provided by:
Abbott

Study Description
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Brief Summary:
The objective of this study is to determine the long-term safety of asoprisnil 10 mg when administered to postmenopausal women with Premarin® 0.625 mg

Condition or disease Intervention/treatment Phase
Postmenopause Drug: Asoprisnil/Premarin Phase 2

Detailed Description:
The objective of this study is to determine the long-term safety of asoprisnil 10 mg (2-5mg tablets) when taken with Premarin® 0.625 mg, by postmenopausal women, for 6 months after an initial 12 weeks in Study M00-198. Pharmacodynamic effects to be assessed include uterine 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Long-Term Extension Safety Study of J867 Administered With Estrogen to Postmenopausal Women
Study Start Date : April 2001
Actual Primary Completion Date : December 2001
Actual Study Completion Date : December 2001

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Asoprisnil/Premarin
10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months


Outcome Measures
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Primary Outcome Measures :
  1. The percent of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System. [ Time Frame: Throughout Study ]
  2. The percentage of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System [ Time Frame: Months 3,6 ]
  3. Change from baseline in endometrial thickness (mm) as measured by transvaginal ultrasound. [ Time Frame: Months 3,6 ]

Secondary Outcome Measures :
  1. Frequency and amount of vaginal bleeding assessed via daily diary. [ Time Frame: Throughout study ]
  2. Frequency and severity of hot flushes assessed via daily diary. [ Time Frame: Throughout study ]
  3. Mean change from baseline in endocrine determinations. [ Time Frame: Months 2,4,and 6 ]
  4. Global efficacy question [ Time Frame: Month 6 ]

Eligibility Criteria
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Ages Eligible for Study:   48 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Successful completion of study M00-198
  • Continued good general health
  • Negative urine pregnancy test

Exclusion Criteria:

  • History of known or suspected cancer other than basal cell carcinoma in last 5 years
  • History of reproductive endocrine disorder
  • Submucous or other symptomatic fibroid which would confound efficacy
  • Ovarian mass
  • Ongoing treatment with an excluded medication
  • Stenosis of the cervix
  • Any abnormal lab result the study-doctor considers significant.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00152295


Sponsors and Collaborators
Abbott
Investigators
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Study Chair: Medical Director Abbott
More Information
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Responsible Party: Cynthia Mattia-Goldberg, Abbott
ClinicalTrials.gov Identifier: NCT00152295    
Other Study ID Numbers: M01-280
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: May 29, 2008
Last Verified: May 2008
Keywords provided by Abbott:
Postmenopausal
Amenorrhea
Hormone replacement therapy
 HRT
asoprisnil
Estrogen Replacement Therapy, postmenopause
Additional relevant MeSH terms:
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Estrogens, Conjugated (USP)
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs