A Long-Term Study to Evaluate the Safety of Asoprisnil and Estrogen Administration to Postmenopausal Women

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: September 7, 2005
Last updated: May 27, 2008
Last verified: May 2008
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 Intervention Phase
Drug: Asoprisnil/Premarin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Long-Term Extension Safety Study of J867 Administered With Estrogen to Postmenopausal Women

Further study details as provided by Abbott:

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

Secondary Outcome Measures:
  • Frequency and amount of vaginal bleeding assessed via daily diary. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Frequency and severity of hot flushes assessed via daily diary. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Mean change from baseline in endocrine determinations. [ Time Frame: Months 2,4,and 6 ] [ Designated as safety issue: No ]
  • Global efficacy question [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: April 2001
Study Completion Date: December 2001
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Asoprisnil/Premarin
10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months

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.

Ages Eligible for Study:   48 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00152295

Sponsors and Collaborators
Study Chair: Medical Director Abbott
  More Information

No publications provided

Responsible Party: Cynthia Mattia-Goldberg, Abbott
ClinicalTrials.gov Identifier: NCT00152295     History of Changes
Other Study ID Numbers: M01-280 
Study First Received: September 7, 2005
Last Updated: May 27, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Hormone replacement therapy
Estrogen Replacement Therapy, postmenopause

Additional relevant MeSH terms:
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 10, 2016