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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00152295
First received: September 7, 2005
Last updated: May 27, 2008
Last verified: May 2008
History of Changes
  Purpose

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
Postmenopause
 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

Resource links provided by NLM:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   48 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152295

Sponsors and Collaborators
Abbott
Investigators
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:
Postmenopausal
Amenorrhea
Hormone replacement therapy
 HRT
asoprisnil
Estrogen Replacement Therapy, postmenopause

Additional relevant MeSH terms:
Estrogens, Conjugated (USP)
Estrogens
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013